Tags

renal cell carcinoma

  • [Kidney tumor in urolithiasis patients: the current state of the problem].

    Along with an increase in the worldwide prevalence of renal tumors and urolithiasis, recently there has been a clear tendency for co-occurrence of the two diseases. An analysis of the literature has revealed several unresolved issues, including the identification of the causal link between the two diseases and determination of rational therapies for their combination, which necessitates a careful investigation of the problem.

    Published March 5, 2017
  • [Radical nephrectomy in a left pelvic dystopic kidney in a patient with renal cell carcinoma].

    The incidence of the renal cell carcinoma in Russia and worldwide remains high. Current literature reports isolated cases of patients who were diagnosed and treated for malignant neoplasms of dystopic kidneys.

    Published April 21, 2017
  • [What can/should be treated in kidney tumors and when].

    In the treatment of localized renal cell carcinoma, the lack of randomization in controlled trials on thermal ablation is a major limitation. The latter leads to significant study bias and it ultimately remains unclear whether the improved overall survival in favor of partial nephrectomy can actually be attributed to the treatment method.

    Published January 30, 2017
  • 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study

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    177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients With Nonprostate Metastatic Solid Tumors: A Pilot Study


    Condition: Kidney Cancer, Head and Neck Cancer, Breast Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Ovarian Cancer, Esophageal Cancer, Gliomas

    Intervention:

    • Drug: 177Lu-J591

    Purpose: The purpose of this study is to evaluate changes in tumor blood flow and disease response to the investigation agent, 177Lu-J591.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT00967577

    Sponsor: Weill Medical College of Cornell University

    Primary Outcome Measures:

    • Measure: Change in tumor perfusion as based on DCE-MRI study as well as changes in cellularity as assessed using DWI.
    • Time Frame: Performed after administration of 177LuJ591 between Day 6-9 and on Day 29.
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Progression free survival
    • Time Frame: Day 58 after administration with 177Lu-J591 and repeated every 3 months until radiographic progression of disease.
    • Safety Issue:

    Estimated Enrollment: 50

    Study Start Date: July 2009

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Histologically, or cytologically documented, advanced stage, malignant adult solid tumors (except prostate cancer) that are refractory to, or recurrent from, standard therapy or for which no curative standard therapy exists. This will include, but is not limited to patients with cancers of the kidney, urothelium, head and neck, breast, non-small cell lung, colorectal, pancreas, ovary, esophagus and gliomas.
    • Metastatic or recurrent solid tumor malignancy defined by abnormal CT, MRI, PET scan, CXR and/or bone scan
    • Progressive disease manifest by: Development of new lesions or an increase in size of preexisting lesions on imaging study or by physical examination.
    • Subjects must have recovered from the acute toxicities of any prior therapy, and not received chemotherapy, radiation therapy or other investigational anticancer therapeutic drug for at least 4 weeks prior to J591 administration in this trial
    • All subjects must have archived or current tissue (from a primary or metastatic focus) available for PSMA determination.
    • Subjects on bisphosphonate therapy or denosumab must be on a stable dose and must have started therapy > 4 weeks prior to protocol therapy.
    • Subjects will be informed as to the potential risk of procreation while participating on this trial and will be advised to use effective contraception during the entire study period. Females of child-bearing potential must have a negative pregnancy test.

    Exclusion Criteria:

    • Use of red blood cell or platelet transfusions within 4 weeks of treatment.
    • Use of hematopoietic growth factors within 4 weeks of treatment.
    • Prior cytotoxic chemotherapy and/or radiation therapy within 4 weeks of treatment.
    • Prior radiation therapy encompassing >25% of skeleton.
    • Prior treatment with 89Strontium or 153Samarium containing compounds (e.g. Metastron®, Quadramet®)
    • Platelet count <150,000/mm3 or history of platelet count abnormality or dysfunction.
    • Absolute neutrophil count (ANC) <2,000/mm3
    • Hematocrit <30 percent or Hemoglobin < 10 g/dL
    • Abnormal coagulation profile (PT or INR, PTT) > 1.3x upper limit of normal (ULN)
    • Serum creatinine > 2x ULN
    • AST (SGOT) >2.5x ULN
    • Bilirubin (total) >1.5x ULN
    • Active serious infection
    • Active angina pectoris or NY Heart Association Class III-IV
    • ECOG Performance Status > 2
    • Deep vein thrombosis and/or pulmonary embolus within 1 month of enrollment.
    • Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
    • Prior investigational therapy (medications or devices) within 6 weeks of treatment.
    • Known history of HIV.
    • Known leukemia or myelodysplastic syndrome
    • Prior allergic reaction to Gadolinium contrast.

    Contact:

    • GUONC Research Team

    Location:

    • Weill Cornell Medical College
    • New York New York 10021 United States

    View trial on ClinicalTrials.gov


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    Published April 30, 2018
  • A Combination Therapy of Partial Nephrectomy and Cryoablation Achieved Good Cancer Control and Renal Function in Bilateral Synchronous Renal Cell Carcinoma.

    We report the case of a 58-year-old Japanese man with bilateral synchronous renal cell carcinoma (RCC). The diameters of the right and left tumors were 56 and 69 mm, respectively. Both tumors were endophytic.

    Published April 23, 2017
  • A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma.

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    A Multicenter, Open-label, Randomized, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib in Combination With Everolimus or Pembrolizumab Versus Sunitinib Alone in First-Line Treatment of Subjects With Advanced Renal Cell Carcinoma (CLEAR)


    Condition: Renal Cell Carcinoma

    Intervention:

    • Drug: lenvatinib
    • Drug: everolimus
    • Drug: pembrolizumab
    • Drug: Sunitinib

    Purpose: This is a multicenter, randomized, open-label, Phase 3 study to compare the efficacy and safety of lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) versus sunitinib (Arm C) as first-line treatment in participants with advanced renal cell carcinoma.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02811861

    Sponsor: Eisai Inc.

    Primary Outcome Measures:

    • Measure: Progression-free survival (PFS) by independent review
    • Time Frame: up to 43 months approximately
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Objective response rate (ORR)
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: Number of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: Number of participants who discontinued treatment due to toxicity
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: Time to treatment failure due to toxicity
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: Health-Related Quality of Life (HRQoL) scores
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: PFS on next-line of therapy (PFS2)
    • Time Frame: up to approximately 53 months
    • Safety Issue:
    • Measure: PFS by investigator assessment
    • Time Frame: up to 53 Months approximately
    • Safety Issue:
    • Measure: Model-predicted clearance for lenvatinib and everolimus
    • Time Frame: 0.5-4 hours (h) and 6-10 h postdose on Cycle 1 Day 1; predose and 2-12 h postdose on Cycle 1 Day 15; predose and 0.5-4 h and 6-10 h postdose on Cycle 2 Day 1; predose on Day 1 of Cycles 3, 4, 5, and 6
    • Safety Issue:
    • Measure: AUC for lenvatinib and everolimus
    • Time Frame: 0.5-4 h and 6-10 h postdose on Cycle 1 Day 1; predose and 2-12 h postdose on Cycle 1 Day 15; predose and 0.5-4 h and 6-10 h postdose on Cycle 2 Day 1; predose on Day 1 of Cycles 3, 4, 5, and 6
    • Safety Issue:

    Estimated Enrollment: 1050

    Study Start Date: October 13, 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Histological or cytological confirmation of renal cell carcinoma (RCC) with a clear-cell component
    • At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST) 1.1
    • Karnofsky Performance Status (KPS) of ≥70
    • Adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mmHg at Screening and no change in antihypertensive medications within 1 week prior to Cycle 1/Day 1 (C1/D1)
    • Adequate organ function per blood work

    Exclusion Criteria:

    • Participants who have received any systemic anticancer therapy for RCC, including anti-vascular endothelial growth factor (VEGF) therapy, or any systemic investigational anticancer agent
    • Participants with central nervous system (CNS) metastases are not eligible, unless they have completed local therapy (eg, whole brain radiation therapy (WBRT), surgery or radiosurgery) and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (eg, radiologic) or symptoms of CNS metastases must be stable for at least 4 weeks before starting study treatment
    • Active malignancy (except for RCC, definitively treated basal or squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix or bladder) within the past 24 months. Participants with history of localized & low risk prostate cancer are allowed in the study if they were treated with curative intent and there is no prostate specific antigen (PSA) recurrence within the past 5 years
    • Prior radiation therapy within 21 days prior to start of study treatment with the exception of palliative radiotherapy to bone lesions, which is allowed if completed 2 weeks prior to study treatment start
    • Received a live vaccine within 30 days of planned start of study treatment
    • Participants with urine protein ≥1 gram/24 hour
    • Fasting total cholesterol >300 milligram per deciliter (mg/dL) (or ˃7.75 millimole per liter (mmol/L)) and/or fasting triglycerides level ˃2.5 x upper limit of normal (ULN). Note: these participants can be included after initiation or adjustment of lipid-lowering medication
    • Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these participants can be included after initiation or adjustment of glucose-lowering medication
    • Prolongation of corrected QT (QTc) interval to >480 milliseconds (ms)
    • Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
    • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug
    • Significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association Class II, unstable angina, myocardial infarction, cerebrovascular accident, or cardiac arrhythmia associated with hemodynamic instability. The following is also excluded: left ventricular ejection fraction below the institutional normal range as determined by multiple-gated acquisition scan or echocardiogram
    • Active infection (any infection requiring systemic treatment)
    • Participants known to be positive for Human Immunodeficiency Virus (HIV).
    • Known active Hepatitis B (eg, Hepatitis B surface antigen (HBsAg) reactive) or Hepatitis C (eg, hepatitis C virus ribonucleic acid (HCV RNA) [qualitative] is detected)
    • Known history of, or any evidence of, interstitial lung disease
    • Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
    • Participants with a diagnosis of immunodeficiency or who are receiving chronic systemic steroid therapy (doses exceeding 10 mg/day of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment. Physiologic doses of corticosteroids (up to 10 mg/day of prednisone or equivalent) may be used during the study
    • Active autoimmune disease (with the exception of psoriasis) that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
    • Known intolerance to any of the study drugs (or any of the excipients)
    • Participant has had an allogenic tissue/solid organ transplant.

    Contact:

    • Eisai Medical Information
    • 1-888-274-2378

    Locations:

    • Stanford University Medical Center
    • Palo Alto California 94305 United States
    • Stanford School of Medicine
    • Stanford California 94305-5826 United States
    • Boca Raton Community Hospital
    • Boca Raton Florida 33486 United States
    • Florida Cancer Specialists
    • Fort Myers Florida 33901 United States
    • Mount Sinai Medical Center
    • Miami Beach Florida 33136 United States
    • University of Miami
    • Miami Florida 33136 United States
    • Florida Hospital Cancer Institute
    • Orlando Florida 32804 United States
    • Florida Cancer Specialists ( North Region)
    • Saint Petersburg Florida 33705 United States
    • Florida Cancer Specialists
    • West Palm Beach Florida 33401 United States
    • Columbus Regional Research Institute
    • Columbus Georgia 31904 United States
    • Cancer Center of Middle Georgia
    • Dublin Georgia 31021 United States
    • Joliet Oncology - Hematology Associates
    • Joliet Illinois 60435 United States
    • Illinois Cancer Specialists
    • Niles Illinois 60714 United States
    • Healthcare Research Network III, LLC
    • Tinley Park Illinois 60487 United States
    • Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Division, LLC
    • Overland Park Kansas 66209 United States
    • SCRI - Tennessee Oncology
    • Overland Park Kansas 66209 United States
    • Cotton-Oneil Clinical Research Center
    • Topeka Kansas 66604 United States
    • Ochsner Clinic Foundation
    • New Orleans Louisiana 70121 United States
    • Associates in Oncology & Hematology, PC
    • Bethesda Maryland 20817 United States
    • Massachusetts General Hospital- MGH
    • Boston Massachusetts 02214 United States
    • Dana Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Karmanos Cancer Center
    • Detroit Michigan 48201 United States
    • Minnesota Oncology Hematology, P.A
    • Minneapolis Minnesota 55404 United States
    • GU Research Network
    • Omaha Nebraska 68130 United States
    • Nebraska Cancer Specialists
    • Omaha Nebraska 68130 United States
    • Cooper Research Institute
    • Camden New Jersey 08103 United States
    • Hackensack Medical Center
    • Hackensack New Jersey 07601 United States
    • Montefiore Medical Center
    • Bronx New York 10461 United States
    • Rosewell Park Cancer Institute
    • Buffalo New York 14263 United States
    • Broome Oncology
    • Johnson City New York 13790 United States
    • Weill Cornell Medical College New York Presbyterian Hospital
    • New York New York 10021 United States
    • Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States
    • Mission Hospital_ Cancer Care of Western North Carolina
    • Asheville North Carolina 28801 United States
    • Oncology Hematology Care
    • Cincinnati Ohio 45242 United States
    • Mid Ohio Oncology Hematology, Inc
    • Columbus Ohio 43219 United States
    • Providence Portland Medical Center
    • Portland Oregon 97213 United States
    • Medical University of South Carolina
    • Charleston South Carolina 29412 United States
    • SCRI - Tennessee Oncology
    • Nashville Tennessee 37203 United States
    • Texas Oncology, P.A.
    • Dallas Texas 75231 United States
    • Texas Oncology PA
    • Fort Worth Texas 76104 United States
    • Texas Oncology PA - McAllen
    • McAllen Texas 78503 United States
    • Texas Oncology PA - Paris
    • Paris Texas 75460 United States
    • Texas Oncology PA - Tyler
    • Tyler Texas 75702 United States
    • Wenatchee Valley Hospital & Clinics
    • Wenatchee Washington 98801 United States
    • Eastern Clinical Research Unit
    • Box Hill Victoria 3128 Australia
    • Austin Hospital
    • Heidelberg Victoria 3084 Australia
    • Box Hill Hospital
    • Box Hill Australia
    • Austin Health
    • Heidelberg Australia
    • Royal Hobart Hospital
    • Hobart Australia
    • Macquarie University Hospital
    • Macquarie park Australia
    • ICON Cancer Foundation
    • South Brisbane Australia
    • Sunshine Hospital
    • St Albans Australia
    • Medizinische Universitat Innsbruck
    • Innsbruck Austria
    • Krankenhaus der barmherzigen Schwestern Linz
    • Linz Austria
    • AKH - Medizinische Universität Wien
    • Vienna 1090 Austria
    • O.L.V Ziekenhuis
    • Aalst Belgium
    • ZNA Middelheim
    • Antwerpen 2260 Belgium
    • ZNA Middelheim
    • Antwerpen Belgium
    • Imeldaziekenhuis
    • Bonheiden Belgium
    • Institut Jules Bordet
    • Bruxelles Belgium
    • Jessa Ziekenhuis - Campus Virga Jesse
    • Hasselt Belgium
    • Domaine Universitaire
    • Liege 4000 Belgium
    • CHU Sart Tilman
    • Liege Belgium
    • GZA Ziekenhuizen - Campus Sint-Augustinus
    • Wilrijk Belgium
    • CHU UCL Namur, Mont-Godinne
    • Yvoir Belgium
    • Cross Cancer Institute
    • Edmonton Alberta T6G 1Z2 Canada
    • BC Cancer Agency Vancouver Centre
    • Vancouver British Columbia V5Z 1H7 Canada
    • St. Joseph's Healthcare Hamilton
    • Hamilton Ontario L8N 4A6 Canada
    • Ottawa Hospital Cancer Centre
    • Ottawa Ontario K1H 8 Canada
    • Sunnybrook Research Institute - University of Toronto
    • Toronto Ontario M4N 3M5 Canada
    • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
    • Greenfield Park Quebec J4V 2H1 Canada
    • London Institute of Health Sciences
    • London Canada
    • Fakultni nemocnice u sv. Anny v Brne
    • Brno Czechia
    • Masarykuv onkologicky ustav
    • Brno Czechia
    • Masarykuv Onkologicky Ustav
    • Hodonice Czechia
    • Fakultni nemocnice Olomouc
    • Olomouc Czechia
    • Fakultni nemocnice v Motole
    • Praha Czechia
    • Nemocnice Na Bulovce
    • Praha Czechia
    • Thomayerova nemocnice
    • Praha Czechia
    • ICO - Site Paul Papin
    • Angers Maine Et Loire 49055 France
    • Centre Georges François Leclerc
    • Dijon cedex 21079 France
    • Centre Georges Francois Leclerc
    • Dijon cedex France
    • Clinique Victor Hugo - Centre Jean Bernard
    • Le Mans Cedex France
    • Centre Leon Berard - Centre regional de lutte contre le cancer Rhone-Alpes
    • Lyon France
    • Institut Regional du Cancer de Montpellier
    • Montpellier France
    • Centre Rene Gauducheau - Centre de Lutte contre le cancer Nantes - Atlantique
    • Nantes France
    • Hopital la Petie Salpetriere
    • Paris cedex 13 75651 France
    • Hopital Europeen Georges Pompidou
    • Paris France
    • Boulevard du Professeur Jacques Monod
    • Saint Herblain 4805 France
    • CHU Strasbourg - Nouvel Hopital Civil
    • Strasbourg France
    • Klinikum Stuttgart-Katharinenhospital
    • Stuttgart Baden Wuerttemberg 70174 Germany
    • Universitaetsklinikum Tuebingen
    • Tuebingen Baden Wuerttemberg 72076 Germany
    • LMU-Campus Grosshadern
    • München Bayern 81377 Germany
    • Klinikum der Johann Wolfgang Goethe-Universitaet
    • Frankfurt Hessen 60590 Germany
    • Medizinische Hochschule Hannover
    • Hannover Niedersachsen 30625 Germany
    • Universitaetsklinikum Muenster
    • Münster Nordrhein Westfalen 48149 Germany
    • Praxis f. Haematologie und Onkologie Koblenz
    • Koblenz Rheinland Pfalz 56068 Germany
    • Universitaetsklinikum des Saarlandes
    • Homburg/Saar Saarland 66421 Germany
    • Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin
    • Berlin 12200 Germany
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
    • Dresden 01307 Germany
    • General Hospital of Athens "Alexandra"
    • Athens 11528 Greece
    • Metropolitan General Hospital
    • Athens 15562 Greece
    • University of Patras Medical School
    • Patras 26504 Greece
    • Euromedica General Clinic Thessaloniki
    • Thessaloníki 54645 Greece
    • General Hospital Papageorgiou
    • Thessaloníki 56429 Greece
    • Interbalkan Hospital of Thessaloniki
    • Thessaloníki 57001 Greece
    • Cork University Hospital,Wilton
    • Cork Ireland
    • Adelaide and Meath Hospital Incorp The National Children's Hospital
    • Dublin Ireland
    • Beaumont Hospital
    • Dublin Ireland
    • University Hospital Galway
    • Galway Ireland
    • Rambam MC
    • Haifa Israel
    • Hadassah University Hospital - Ein Kerem
    • Jerusalem Israel
    • Sapir Medical Center, Meir Hospital
    • Kfar-Saba Israel
    • Rabin Medical Center
    • Petah Tikva 49100 Israel
    • Chaim Sheba Medical Center
    • Ramat-Gan Israel
    • Assaf Harofeh
    • Rishon Lezion Israel
    • Tel Aviv Sourasky Medical Center
    • Tel Aviv Israel
    • Azienda Unità Sanitaria Locale- Ravenna
    • Faenza Ravenna 48018 Italy
    • Ospedale San Donato
    • Arezzo Italy
    • Azienda Ospedaliera Universitaria Policlinico SantOrsola Malpighi
    • Bologna Italy
    • Istituto Nazionale per la Ricerca sul Cancro di Genova
    • Genova 16132 Italy
    • Presidio Ospedaliero Vito Fazzi
    • Lecce 73100 Italy
    • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST
    • Meldola Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Milano 20133 Italy
    • A.O.U. Policlinico di Modena
    • Modena 41124 Italy
    • Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli
    • Napoli 80131 Italy
    • Istituto Nazionale Tumori Fondazione G. Pascale
    • Napoli Italy
    • Fondazione IRCCS Policlinico San Matteo
    • Pavia Italy
    • Azienda Ospedaliera Santa Maria Degli Angeli
    • Pordenone 33170 Italy
    • Azienda Ospedaliera San Camillo Forlanini
    • Roma Italy
    • Universita Campus Bio-Medico di Roma
    • Rome Italy
    • Facility #1
    • Aichi Japan
    • Facility #2
    • Aichi Japan
    • Facility #1
    • Akita Japan
    • Facility #1
    • Aomori Japan
    • Facility #1
    • Chiba Japan
    • Facility #2
    • Chiba Japan
    • Facility #1
    • Fukuoka Japan
    • Facility #1
    • Hiroshima Japan
    • Facility #1
    • Hokkaido Japan
    • Facility #2
    • Hokkaido Japan
    • Facility #1
    • Hyogo Japan
    • Facility #1
    • Kagawa Japan
    • Facility #1
    • Kanagawa Japan
    • Facility #2
    • Kanagawa Japan
    • Facility #3
    • Kanagawa Japan
    • Facility #1
    • Kyoto Japan
    • Facility #1
    • Nagasaki Japan
    • Facility #1
    • Nara Japan
    • Facility #1
    • Niigata Japan
    • Facility #1
    • Okayama Japan
    • Facility #1
    • Osaka Japan
    • Facility #2
    • Osaka Japan
    • Facility #1
    • Saitama Japan
    • Facility #1
    • Tokushima Japan
    • Facility #1
    • Tokyo Japan
    • Facility #2
    • Tokyo Japan
    • Facility #3
    • Tokyo Japan
    • Facility #4
    • Tokyo Japan
    • Facility #5
    • Tokyo Japan
    • Facility #6
    • Tokyo Japan
    • Kyungpook National University Chilgok Hospital
    • Daegu 41404 Korea, Republic of
    • National Cancer Center
    • Goyang-si Korea, Republic of
    • Seoul National University Bundang Hospital
    • Seongnam-si Korea, Republic of
    • Asan Medical Center: Medical Oncology Department
    • Seoul Korea, Republic of
    • Asan Medical Center: Urology Department
    • Seoul Korea, Republic of
    • Samsung Medical Center
    • Seoul Korea, Republic of
    • Seoul National University Hospital
    • Seoul Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Seoul Korea, Republic of
    • The Catholic University of Korea, Seoul St. Mary's Hospital
    • Seoul Korea, Republic of
    • Antoni van Leeuwenhoek
    • Amsterdam 1066 CX Netherlands
    • VU Medisch Centrum
    • Amsterdam 1081 HV Netherlands
    • UMC Utrecht
    • Utrecht 3584 CX Netherlands
    • Uniwersyteckie Centrum Kliniczne
    • Gdansk Poland
    • Instytut MSF Sp. o.o
    • Lodz Poland
    • Dr n med. Slawomir Mandziuk Specjalistyczna Praktyka Lekarska
    • Lublin Poland
    • SPWSZ w Szczecinie im. Marii Sklodowskiej-Curie
    • Szczecin Poland
    • FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
    • Moscow 115478 Russian Federation
    • FSBI "Moscow scientific research oncology institute n.a. P.A. Gertsen" of MoH of RF
    • Moscow 125284 Russian Federation
    • FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin
    • Moscow Russian Federation
    • FBHI Privolzhskiy District Medical Centre FMBA of Russia
    • Nizhniy Novgorod Russian Federation
    • SBHI of Novosibirsk region "Novosibirsk Regional Oncological Dispensary"
    • Novosibirsk 630108 Russian Federation
    • FSBI "National Medical Research Radiological Center" of the MoH of the RF
    • Obninsk 249036 Russian Federation
    • BHI of Omsk region "Clinical Oncology Dispensary"
    • Omsk 644013 Russian Federation
    • Medicinskiy gorod
    • Tyumen 625041 Russian Federation
    • Hospital Universitario Marques de Valdecilla
    • Santander Cantabria 39008 Spain
    • Hospital Clinic de Barcelona
    • Barcelona 08036 Spain
    • Hospital de la Santa Creu i Sant Pau
    • Barcelona Spain
    • Hospital Universitari Vall d'Hebron
    • Barcelona Spain
    • Complejo Asistencial Universitario de Burgos
    • Burgos 09005 Spain
    • Servicio de Oncologia
    • Caceres 10003 Spain
    • Hospital San Pedro de Alcantara
    • Caceres Spain
    • Hospital Universitario Reina Sofia
    • Cordoba Spain
    • Avinguda Gran Via de l'Hospitalet
    • L'Hospitalet de Llobregat, 08908 Spain
    • ICO l'Hospitalet - Hospital Duran I Reynals
    • L'Hospitalet de Llobregat Spain
    • Hospital Universitario Lucus Augusti
    • Lugo 27003 Spain
    • Servicio Oncologia Médica - planta -2 derecha- Oficina ensayos clínicos
    • Madrid 28034 Spain
    • Hospital General Universitario Gregorio Maranon
    • Madrid Spain
    • Hospital Universitario Clinico San Carlos
    • Madrid Spain
    • Hospital Universitario HM Madrid Sanchinarro
    • Madrid Spain
    • Hospital Universitario Ramon y Cajal
    • Madrid Spain
    • MD Anderson Cancer Centre
    • Madrid Spain
    • Servicio de Oncologia
    • Oviedo 33011 Spain
    • Hospital Universitario Central de Asturias
    • Oviedo Spain
    • Hospital Universitario Virgen del Rocio
    • Seville Spain
    • Oncologia
    • Valencia 46009 Spain
    • Fundacion Instituto Valenciano de Oncologia
    • Valencia Spain
    • Inselspital - Universitaetsspital Bern
    • Bern Switzerland
    • Kantonsspital Winterthur
    • Winterthur Switzerland
    • Royal Bournemouth General Hospital
    • Bournemouth United Kingdom
    • Velindre Cancer Centre
    • Cardiff United Kingdom
    • Western General Hospital
    • Edinburgh United Kingdom
    • Beatson West Of Scotland Cancer Centre
    • Glasgow G12 0YN United Kingdom
    • St. James's University Hospital
    • Leeds LS9 7TF United Kingdom
    • Guy's Hospital
    • London United Kingdom
    • Royal Free Hospital
    • London United Kingdom
    • Christie Hospital NHS Foundation Trust
    • Manchester M20 4BX United Kingdom

    View trial on ClinicalTrials.gov


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    Published June 8, 2017
  • A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (KEYNOTE-037/ ECHO-202)

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    A Phase 1/2 Study Exploring the Safety, Tolerability, and Efficacy of Pembrolizumab (MK-3475) in Combination With Epacadostat (INCB024360) in Subjects With Selected Cancers (KEYNOTE-037/ ECHO-202)


    Condition: Colorectal Cancer (CRC), Endometrial Cancer, Head and Neck Cancer, Hepatocellular Carcinoma (HCC), Gastric Cancer, Lung Cancer, Lymphoma, Renal Cell Carcinoma (RCC), Ovarian Cancer, Solid Tumors, UC (Urothelial Cancer), Breast Cancer, Melanoma

    Intervention:

    • Drug: MK-3475
    • Drug: INCB024360

    Purpose: The purpose of this study is to assess the safety, tolerability, and efficacy when combining MK-3475 and INCB024360 in subjects with certain cancers. This study will be conducted in 2 phases, Phase 1 and Phase 2.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02178722

    Sponsor: Incyte Corporation

    Primary Outcome Measures:

    • Measure: Phase 1: Number of subjects with dose limiting toxicities (DLTs) of INCB024360 in combination with MK-3475
    • Time Frame: 56 days
    • Safety Issue:
    • Measure: Phase 2: Objective response rate
    • Time Frame: Assessed every 9 weeks for duration of study participation which is estimated to be 18 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Progression free survival
    • Time Frame: Response is measured every 9 weeks for duration of study participation which is estimated to be 18 months
    • Safety Issue:
    • Measure: Number of subjects with Adverse Events as a Measure of Safety and Tolerability of INCB024360 in combination with MK-3475
    • Time Frame: Adverse events are assessed every 3 weeks for duration of study participation which is estimated to be 18 months
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: Patients are checked for survival every 12 weeks for duration of study participation which is estimated to be 18 months
    • Safety Issue:

    Estimated Enrollment: 508

    Study Start Date: June 2014

    Phase: Phase 1/Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Subjects with histologically or cytologically NSCLC, melanoma, transitional cell carcinoma of the genitourinary (GU) tract, renal cell cancer, triple negative breast cancer, adenocarcinoma of the endometrium or squamous cell carcinoma of the head and neck (Phase 1).
    • Subjects with histologically confirmed melanoma, NSCLC, transitional cell carcinoma of the GU tract, TNBC, SCCHN, ovarian cancer, MSI high colorectal cancer (CRC), RCC, gastric cancer, HCC and DLBCL (Phase 2).
    • Life expectancy > 12 weeks.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0
    • 1.
    • Presence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 or Lugano Classification for subjects with DLBCL.
    • Laboratory and medical history parameters within protocol-defined range.
    • For Phase 1: Subjects who have advanced or metastatic disease as noted above that have received at least one prior therapy or have advanced or metastatic disease for which no curative treatment is available may be enrolled.
    • For Phase 2 expansion cohorts: Subjects with NSCLC, melanoma (checkpoint inhibitor naïve, primary refractory melanoma, relapsed melanoma), transitional cell carcinoma of the GU tract, SCCHN, ovarian cancer, MSI high CRC, RCC, DLBCL, and TNBC.
    • Phase 2 expansion: NSCLC
    • Subjects who have received at least 1 prior platinum-based therapy. Subjects who have a non-platinum-based regimen may be enrolled with medical monitor approval.
    • Tumors with epidermal growth factor receptor mutation positive or anaplastic lymphoma kinase fusion oncogene positive treated with a tyrosine kinase inhibitor are permitted; however, subjects should have progressed on or be intolerant to the targeted therapy.
    • Subjects must not have received immunotherapy with programmed death receptor-1 (PD-1) or cytotoxic T-lymphocyte antigen (CTLA-4) targeted therapy.
    • Phase 2 expansion: Melanoma
    • Documentation of V600E-activating BRAF mutation status.
    • Prior systemic therapy requirements.
    • Melanoma immune checkpoint-naïve: Subjects must not have received immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy. Exception: Prior anti−CTLA-4 in the adjuvant setting would be permitted.
    • Primary refractory melanoma: Subjects must have received prior treatment with anti-PD-1 or anti-PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and have progressive disease as their best response to treatment that is confirmed 4 weeks later.
    • Relapsed melanoma: Subjects must have received prior anti−PD-1 or anti−PD-L1 therapy (alone or as part of a combination) in the advanced or metastatic setting and achieved partial response ore complete response but later have confirmed progressive disease.
    • Subjects enrolling in the primary refractory or relapsed melanoma must be willing to undergo mandatory pretreatment and on-treatment biopsies.
    • Ocular melanoma is excluded.
    • Phase 2 expansion: Transitional cell carcinoma of the GU tract
    • Metastatic or locally advanced and not amenable to curative therapy with disease progression on or after platinum-based chemotherapy or alternative therapy if platinum-based therapy is not appropriate.
    • Prior PD-1 or CTLA-4 targeted therapies are excluded
    • Phase 2 expansion: SCCHN
    • Histologically confirmed metastatic or recurrent squamous cell carcinoma not amenable to local therapy with curative intent (surgery or radiation with or without chemotherapy). Carcinoma of the nasopharynx, salivary gland, or * *Subjects must have received at least 1 prior systemic chemotherapy regimen that must have included a platinum-based therapy.
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Phase 2 expansion: Ovarian cancer
    • Subjects with FIGO Stage Ic, Stage II, Stage III, Stage IV, recurrent, or persistent (unresectable) histologically confirmed epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube carcinoma.
    • Subjects must have received a platinum-taxane-based regimen as first-line therapy.
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Borderline, low-malignant-potential epithelial carcinoma per histopathology is excluded.
    • Phase 2 expansion: Relapsed or refractory DLBCL
    • Prior allogeneic stem-cell transplantation is excluded.
    • Must have received > or = 1 prior treatment regimen.
    • Not a candidate for curative therapy or hematopoietic stem-cell transplantation (either due to disease burden, fitness, or preference).
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Phase 2 expansion: TNBC
    • Histologically confirmed breast adenocarcinoma that is unresectable loco regional, or metastatic
    • Pathologically confirmed as triple negative, source documented, defined as both of the following:
    • Estrogen receptor (ER) and progesterone receptor (PgR) negative.
    • Human epidermal growth factor receptor 2 (HER2) negative as per American Society of Clinical Oncology/College of American Pathologists guidelines.
    • Subject must have received at least 1 prior systemic regimen for advanced or metastatic disease
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Phase 2 expansion: RCC
    • Subjects with histological or cytological confirmation of clear cell RCC.
    • Not curable by surgery.
    • Subjects must have received prior antiangiogenic therapy.
    • Subjects must not have received prior immunotherapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy.
    • Phase 2 expansion: MSI high CRC
    • Subjects with histological confirmation of locally advanced unresectable or metastatic MSI high CRC.
    • MSI status is, respectively, determined by examining CRC tumor.
    • Subjects may have received no more than 2 lines of prior therapy for advanced disease.
    • Phase 2 expansion: Gastric Cancer
    • Must have histologically or cytologically confirmed diagnosis of gastric or gastroesophageal junction adenocarcinoma.
    • Must have progression on or after therapy containing platinum/fluoropyrimidine or refused standard therapy.
    • Subjects may have received no more than 2 lines of prior therapy for advanced disease.
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Phase 2 expansion: HCC
    • Must have histologically or cytologically confirmed diagnosis of HCC (fibrolamellar and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible).
    • Barcelona Clinic Liver Cancer (BCLC) Stage C disease (Llovet et al 1999), or BCLC Stage B disease.
    • Subjects may have received no more than 2 lines of prior therapy for the advanced disease
    • Must have progressed on, refused, or were intolerant of sorafenib.
    • The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within 28 days of starting study treatment.
    • Prior PD-1 or CTLA-4 targeted therapies are excluded.
    • Tumor biopsies are required. If a subject has inaccessible lesions, such as in ovarian cancer, HCC, or gastric cancer, or highly vascular lesions, such as RCC, enrollment may be considered with medical monitor approval, and archived tissue may be acceptable.
    • Females of child-bearing potential and males who use adequate birth control through 120 days post dose.

    Exclusion Criteria:

    • Subjects who participated in any other study in which receipt of an investigational study drug or device occurred within 2 weeks or 5 half-lives (whichever is longer) prior to first dose.
    • Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). Exception: Prior anti−CTLA-4 in the adjuvant setting for subjects with melanoma would be permitted.
    • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable.
    • Has an active autoimmune disease.
    • Has evidence of noninfectious pneumonitis that required steroids or current pneumonitis.
    • Live vaccine use within 30 days of first dose of study medication.
    • Monoamine oxidase inhibitors.

    Contact:

    • Incyte Call Center
    • 1-855-463-3463

    Locations:

    • UC San Diego Moores Cancer Center
    • La Jolla California 92093 United States
    • The Angeles Clinic and Research Institute
    • Los Angeles California 90025 United States
    • US Davis Cancer Center
    • Sacramento California 95817 United States
    • University Of Colorado Cancer Center
    • Aurora Colorado 80045 United States
    • University of Connecticut Health Center Carole And Ray Neag Comprehensive Cancer Center
    • Farmington Connecticut 06030-1601 United States
    • Miami Cancer Institute at Baptist Health, Inc
    • Miami Florida 33176 United States
    • Georgia Cancer Specialists affiliated with Northside Hospital Cancer Institute
    • Atlanta Georgia 30342 United States
    • The University of Chicago Medicine
    • Chicago Illinois 60637 United States
    • St. Francis Cancer Center
    • Topeka Kansas 66618 United States
    • Greater Baltimore Cancer Center
    • Baltimore Maryland 21204 United States
    • St. Agnes Hospital Cancer Institute
    • Baltimore Maryland 21229 United States
    • The Center for Cancer and Blood Disorders (RCCA MD LLC- Maryland Division)
    • Bethesda Maryland 20817 United States
    • University of Michigan Hospital and Health Systems
    • Ann Arbor Michigan 48109 United States
    • Health Partners Institute
    • Saint Louis Park Minnesota 55426 United States
    • Hackensack University Medical Center - John Theurer Cancer Center
    • Hackensack New Jersey 07601 United States
    • The Christ Hospital Hematology Oncology, Lindner Research Center
    • Cincinnati Ohio 45219 United States
    • University of Pennsylvania Hospital
    • Philadelphia Pennsylvania 19104 United States
    • Fox Chase Cancer Center
    • Philadelphia Pennsylvania 19111-2497 United States
    • University of Pittsburgh Medical Center Hillman Cancer Center
    • Pittsburgh Pennsylvania 15232 United States
    • Greenville Health System Cancer Institute
    • Greenville South Carolina 29605 United States
    • West Cancer Center
    • Germantown Tennessee 38120 United States
    • Sarah Cannon Research Institute at Tennessee Oncology
    • Nashville Tennessee 37203-2173 United States
    • University Of Texas Southwestern Medical Center At Dallas
    • Dallas Texas 75390 United States
    • Virginia Cancer Specialists
    • Arlington Virginia 22031 United States

    View trial on ClinicalTrials.gov


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    Published December 5, 2017
  • A Phase 3, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In The First-line Treatment Of Patients With Advanced Renal

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    A Phase 3, Multinational, Randomized, Open-label, Parallel-arm Study Of Avelumab (msb0010718c) In Combination With Axitinib (Inlyta(Registered)) Versus Sunitinib (Sutent(Registered)) Monotherapy In The First-line Treatment Of Patients With Advanced Renal Cell Carcinoma


    Condition: Renal Cell Cancer

    Intervention:

    • Drug: Avelumab (MSB0010718C)
    • Drug: Axitinib (AG-013736)
    • Drug: Sunitinib

    Purpose: This is a phase 3 randomized trial evaluating the anti-tumor activity and safety of avelumab in combination with axitinib and of sunitinib monotherapy, administered as first-line treatment, in patients with advanced renal cell carcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02684006

    Sponsor: Pfizer

    Primary Outcome Measures:

    • Measure: Progression Free Survival (PFS) in PD-L1 positive patients
    • Time Frame: From randomization up to 30 months.
    • Safety Issue:
    • Measure: Overall Survival in PD-L1 positive patients
    • Time Frame: Every 3 months up to 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall Survival (OS) in unselected patients
    • Time Frame: Every 3 months up to 5 years
    • Safety Issue:
    • Measure: Number of participants with Objective Response (OR)
    • Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 months from randomization
    • Safety Issue:
    • Measure: Disease Control (DC)
    • Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 months from randomization
    • Safety Issue:
    • Measure: Time to Tumor Response (TTR)
    • Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 months from randomization
    • Safety Issue:
    • Measure: Duration of response (DR)
    • Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 months from randomization
    • Safety Issue:
    • Measure: Progression Free Survival (PFS) by Investigator assessment
    • Time Frame: Every 6 weeks up to 18 months from patient enrollment in the study, then every 12 weeks up to 30 months from randomization
    • Safety Issue:
    • Measure: Trough plasma concentration (Ctrough) of avelumab
    • Time Frame: Pre-dose
    • Safety Issue:
    • Measure: Trough plasma concentration (Ctrough) of axitinib
    • Time Frame: Pre-dose
    • Safety Issue:
    • Measure: Maximum plasma concentration (Cmax) of axitinib
    • Time Frame: 2 hours post-dose
    • Safety Issue:
    • Measure: Anti-Drug Antibody (ADA) levels of avelumab/Neutralizing antibodies titers for MSB0010718C
    • Time Frame: Pre-dose
    • Safety Issue:
    • Measure: Tumor tissue biomarker status
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Overall Survival (OS) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Change From Baseline in FACT-Kidney Symptom Index (FKSI)-19
    • Time Frame: Every 6 weeks up to 3 years
    • Safety Issue:
    • Measure: Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Health State Profile
    • Time Frame: Every 6 weeks up to 3 years
    • Safety Issue:
    • Measure: Progression Free Survival (PFS) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Objective Response (OR) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Disease Control (DC) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Time To Response (TTR) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Duration of Response (DR) in biomarker-positive and biomarker-negative subgroups
    • Time Frame: Baseline
    • Safety Issue:
    • Measure: Change from Baseline in European Quality of Life Questionnaire (EQ-5D) - Visual Analogic Scale
    • Time Frame: Every 6 weeks up to 3 years
    • Safety Issue:
    • Measure: Time to treatment discontinuation/failure due to toxicity (TTF)
    • Time Frame: From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
    • Safety Issue:
    • Measure: Treatment discontinuation/failure due to toxicity
    • Time Frame: From Cycle 1 Day 1, every 6 weeks up to the End of Treatment
    • Safety Issue:
    • Measure: PFS on next-line therapy (PFS2)
    • Time Frame: From randomization up to 5 years.
    • Safety Issue:
    • Measure: Progression Free Survival (PFS) in unselected patients
    • Time Frame: From randomization up to 30 months.
    • Safety Issue:

    Estimated Enrollment: 830

    Study Start Date: March 23, 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Histologically or cytologically confirmed advanced or metastatic RCC with clear cell component
    • Availability of a formalin-fixed, paraffin-embedded (FFPE) tumor tissue block from a de novo tumor biopsy during screening (biopsied tumor lesion should not be a RECIST target lesion). Alternatively, a recently obtained archival FFPE tumor tissue block (not cut slides) from a primary or metastatic tumor resection or biopsy can be provided if the following criteria are met: 1) the biopsy or resection was performed within 1 year of randomization AND 2) the patient has not received any intervening systemic anti-cancer treatment from the time the tissue was obtained and randomization onto the current study. If an FFPE tissue block cannot be provided as per documented regulations then, 15 unstained slides (10 minimum) will be acceptable
    • Availability of an archival FFPE tumor tissue from primary tumor resection specimen (if not provided per above). If an FFPE tissue block cannot be providedas per documented regulations 15 unstained slides (10 minimum) will be acceptable
    • At least one measureable lesion as defined by RECIST version 1.1 that has not been previously irradiated
    • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
    • Adequate bone marrow function, renal and liver functions

    Exclusion Criteria:

    • Prior systemic therapy directed at advanced or metastatic RCC
    • Prior adjuvant or neoadjuvant therapy for RCC if disease progression or relapse has occurred during or within 12 months after the last dose of treatment.
    • Prior immunotherapy with IL-2, IFN-α, or anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab), or any other antibody or drug specifically targeting T cell co stimulation or immune checkpoint pathways
    • Prior therapy with axitinib and/or sunitinib as well as any prior therapies with other VEGF pathway inhibitors
    • Newly dignosed or active brain metastasis
    • Known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥3), any history of anaphylaxis, or uncontrolled asthma (ie, 3 or more features of partially controlled asthma Global Initiative for Asthma 2011)
    • Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, LVEF less than LLN, clinically significant pericardial effusion, cerebrovascular accident, transient ischemic attack
    • Any of the following in the previous 6 months: deep vein thrombosis or symptomatic pulmonary embolism
    • Vaccination within 4 weeks of the first dose of avelumab and while on trial is prohibited except for administration of inactivated vaccines (for example, inactivated influenza vaccines)

    Contact:

    • Pfizer CT.gov Call Center
    • 1-800-718-1021

    Locations:

    • Southern Cancer Center
    • Daphne Alabama 36526 United States
    • Southern Cancer Center
    • Mobile Alabama 36607 United States
    • Southern Cancer Center
    • Mobile Alabama 36608 United States
    • Tower Hematology Oncology Medical Group
    • Beverly Hills California 90211 United States
    • City of Hope National Medical Center
    • Duarte California 91010 United States
    • City of Hope
    • Duarte California 91010 United States
    • Keck Hospital of USC
    • Los Angeles California 90033 United States
    • LAC + USC Medical Center
    • Los Angeles California 90033 United States
    • USC/Norris Comprehensive Cancer Center
    • Los Angeles California 90033 United States
    • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    • Los Angeles California 90048 United States
    • Cedars-Sinai
    • Los Angeles California 90048 United States
    • Hematology-Oncology Medical Group of Orange County (HOMG)
    • Orange California 92868 United States
    • Medical Oncology Care Associates (MOCA)
    • Orange California 92868 United States
    • St. Joseph Hospital of Orange
    • Orange California 92868 United States
    • The Center for Cancer Prevention and Treatment at St. Joseph Hospital of Orange
    • Orange California 92868 United States
    • Edward Alexson, MD, Inc.
    • Santa Ana California 92705 United States
    • Rocky Mountain Cancer Centers
    • Aurora Colorado 80012 United States
    • Anschutz Cancer Center Pavilion Pharmacy
    • Aurora Colorado 80045 United States
    • Genitourinary Oncology
    • Aurora Colorado 80045 United States
    • University of Colorado Cancer Center Anschutz Cancer Pavilion
    • Aurora Colorado 80045 United States
    • University of Colorado Cancer Center
    • Aurora Colorado 80045 United States
    • Rocky Mountain Cancer Centers
    • Colorado Springs Colorado 80907 United States
    • Georgetown University Medical Center
    • Washington District of Columbia 20007 United States
    • Moffitt Cancer Center and Research Institute
    • Tampa Florida 33612 United States
    • Moffitt Cancer Center
    • Tampa Florida 33612 United States
    • Emory University Hospital
    • Atlanta Georgia 30322 United States
    • Investigational Drug Service- Emory University
    • Atlanta Georgia 30322 United States
    • The Emory Clinic
    • Atlanta Georgia 30322 United States
    • Winship Cancer Institute, Emory University
    • Atlanta Georgia 30322 United States
    • East Jefferson General - Inpatient Pharmacy
    • Metairie Louisiana 70006 United States
    • East Jefferson General Hospital
    • Metairie Louisiana 70006 United States
    • East Jefferson Hematology-Oncology Metairie Physician Service Inc.
    • Metairie Louisiana 70006 United States
    • New England Cancer Specialists
    • Brunswick Maine 04011 United States
    • New England Cancer Specialists
    • Kennebunk Maine 04043 United States
    • New England Cancer Specialists
    • Scarborough Maine 04074 United States
    • Oncology Investigational Drug Services- The Sidney Kimmel Cancer Center at Johns Hopkins Hospital
    • Baltimore Maryland 21231 United States
    • The Sidney Kimmel Comprehensive Cancer Center
    • Baltimore Maryland 21231 United States
    • Johns Hopkins Hospital
    • Baltimore Maryland 21287 United States
    • Massachusetts General Hospital (MGH)
    • Boston Massachusetts 02114 United States
    • Massachusetts General Hospital Clinical Trials Pharmacy
    • Boston Massachusetts 02114 United States
    • Brigham & Women's Hospital
    • Boston Massachusetts 02115 United States
    • Beth Israel Deaconess Medical Center (BIDMC)
    • Boston Massachusetts 02215 United States
    • Beth Israel Deaconess Medical Center Pharmacy - BIDMC
    • Boston Massachusetts 02215 United States
    • Dana-Farber Cancer Institute
    • Boston Massachusetts 02215 United States
    • Mayo Clinic
    • Rochester Minnesota 55905 United States
    • Barnes-Jewish Hospital, Siteman Cancer Center - West County
    • Creve Coeur Missouri 63141 United States
    • Barnes-Jewish Hospital, Siteman Cancer Center
    • Saint Louis Missouri 63110 United States
    • Washington University Infusion Center Pharmacy
    • Saint Louis Missouri 63110 United States
    • Washington University School of Medicine
    • Saint Louis Missouri 63110 United States
    • Barnes-Jewish Hospital, Siteman Cancer Center - South County
    • Saint Louis Missouri 63129 United States
    • Barnes-Jewish Hospital, Siteman Cancer Center - St. Peters
    • Saint Peters Missouri 63376 United States
    • St. Vincent Healthcare
    • Billings Montana 59101 United States
    • St. Vincent Frontier Cancer Center
    • Billings Montana 59102 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89148 United States
    • Comprehensive Cancer Centers of Nevada
    • Las Vegas Nevada 89169 United States
    • New York Oncology Hematology, P.C.
    • Albany New York 12206 United States
    • New York Oncology Hematology, PC
    • Albany New York 12208 United States
    • New York Oncology Hematology, P.C.
    • Clifton Park New York 12065 United States
    • Laura & Isaac Perlmutter Cancer Center at NYU Langone
    • New York New York 10016 United States
    • NYU Investigational Pharmacy
    • New York New York 10016 United States
    • NYU Langone Medical Center
    • New York New York 10016 United States
    • MSKCC-Monitoring Suite
    • New York New York 10017 United States
    • MSKCC Department of Laboratory Medicine-Main
    • New York New York 10065 United States
    • Sidney Kimmel-Memorial Sloan Kettering Cancer Center
    • New York New York 10065 United States
    • Stony Brook University
    • Stony Brook New York 11794-7007 United States
    • Stony Brook University Medical Center Cancer Center Division of Oncology / Hematology
    • Stony Brook New York 11794 United States
    • Stony Brook University
    • Stony Brook New York 11794 United States
    • Novant Health Oncology Specialists
    • Kernersville North Carolina 27284 United States
    • Novant Health Oncology Specialists
    • Lexington North Carolina 27295 United States
    • Novant Health Oncology Specialists
    • Mount Airy North Carolina 27030 United States
    • Novant Health Oncology Specialists
    • North Wilkesboro North Carolina 28659 United States
    • Novant Health Oncology Specialists
    • Winston-Salem North Carolina 27103 United States
    • Novant Health Winston Salem Health Care
    • Winston-Salem North Carolina 27103 United States
    • Cleveland Clinic Investigational Pharmacy
    • Cleveland Ohio 44195 United States
    • Cleveland Clinic
    • Cleveland Ohio 44195 United States
    • James Cancer Hospital and Solove Research Institute
    • Columbus Ohio 43210 United States
    • The Ohio State University - GU Clinic
    • Columbus Ohio 43210 United States
    • The Ohio State University
    • Columbus Ohio 43210 United States
    • Cancer Care Associates Medical Oncology
    • Allentown Pennsylvania 18104 United States
    • St.Luke's Hospital-Allentown Campus
    • Allentown Pennsylvania 18104 United States
    • Cancer Care Associate Medical Oncology
    • Bethlehem Pennsylvania 18015 United States
    • St.Luke's University Health Network
    • Bethlehem Pennsylvania 18015 United States
    • St.Luke's Cancer Center Anderson
    • Easton Pennsylvania 18045 United States
    • St.Luke's Hospital-Anderson Campus
    • Easton Pennsylvania 18045 United States
    • Investigational Drug Service, University of Pennsylvania
    • Philadelphia PennsyIvania Pennsylvania 19104 United States
    • Hospital of the University of Pennsylvania
    • Philadelphia Pennsylvania 19104 United States
    • St.Luke's Quakertown Hospital
    • Quakertown Pennsylvania 18951 United States
    • Memorial Hospital
    • York Pennsylvania 17405 United States
    • Tennessee Cancer Specialists
    • Harrogate Tennessee 37752 United States
    • Tennessee Cancer Specialists
    • Knoxville Tennessee 37909 United States
    • Tennessee Cancer Specialists
    • Morristown Tennessee 37813 United States
    • Henry-Joyce Cancer Clinic
    • Nashville Tennessee 37232 United States
    • Vanderbilt University Oncology Pharmacy
    • Nashville Tennessee 37232 United States
    • Tennessee Cancer Specialists
    • Newport Tennessee 37821 United States
    • Texas Oncology - Baylor Charles A. Sammons Cancer Center
    • Dallas Texas 75246 United States
    • Investigational Product Center (IPC)
    • Fort Worth Texas 76177 United States
    • Investigational Products Center (IPC) Drug Shipment Only
    • Fort Worth Texas 76177 United States
    • Investigational Products Center (IPC)
    • Fort Worth Texas 76177 United States
    • Investigational Products Center (lPC)
    • Fort Worth Texas 76177 United States
    • Texas Oncology- Memorial City
    • Houston Texas 77024 United States
    • The University of Texas MD Anderson Cancer Center
    • Houston Texas 77030 United States
    • Joe Arrington Cancer Research and Treatment Center
    • Lubbock Texas 79410 United States
    • Rainier Hematology-Oncology, PC
    • Puyallup Washington 98373 United States
    • Seattle Cancer Care Alliance / University of Washington
    • Seattle Washington 98109 United States
    • Seattle Cancer Care Alliance
    • Seattle Washington 98109 United States
    • Northwest Medical Specialties, PLLC
    • Tacoma Washington 98405 United States
    • Macquarie University Hospital Pharmacy
    • Macquarie University New South Wales 2109 Australia
    • Macquarie University
    • Macquarie University New South Wales 2109 Australia
    • Nuclear Medicine Department
    • Randwick New South Wales 2031 Australia
    • Pharmacy Department, Clinical Trials
    • Randwick New South Wales 2031 Australia
    • Prince of Wales Hospital
    • Randwick New South Wales 2031 Australia
    • Spectrum Medical Imaging
    • Randwick New South Wales 2031 Australia
    • Division of Cancer Services
    • Woolloongabba Queensland 4102 Australia
    • Main Pharmacy
    • Woolloongabba Queensland 4102 Australia
    • Metro South Health Queensland
    • Woolloongabba Queensland 4102 Australia
    • Lake Imaging
    • Ballarat Victoria 3350 Australia
    • Box Hill Hospital
    • Box Hill Victoria 3128 Australia
    • Eastern Health
    • Box Hill Victoria 3128 Australia
    • Monash Health Translational Precinct
    • Clayton Victoria 3168 Australia
    • Moorabbin Radiology
    • East Bentleigh Victoria 3156 Australia
    • Monash Cancer Centre
    • East Bentleigh Victoria 3165 Australia
    • Ballarat Day Procedure Centre
    • Wendouree Victoria 3355 Australia
    • Ballarat Oncology & Haematology Services
    • Wendouree Victoria 3355 Australia
    • Nova Pharmacy
    • Wendouree Victoria 3355 Australia
    • Slade Health
    • West Melbourne Victoria 3003 Australia
    • SKG Radiology
    • Murdoch Western Australia 6050 Australia
    • Fiona Stanley Hospital
    • Murdoch Western Australia 6150 Australia
    • SKG Radiology
    • Murdoch Western Australia 6150 Australia
    • St John of God Murdoch Hospital
    • Murdoch Western Australia 6150 Australia
    • EPIC Pharmacy Murdoch
    • Perth Western Australia 6150 Australia
    • Krankenhaus der Barmherzigen Schwestern Wien
    • Wien 1060 Austria
    • Allgemeines Krankenhaus Wien
    • Wien 1090 Austria
    • Medizinische Universitaet Wien
    • Wien 1090 Austria
    • Universitaetsklinik fur Radiologie und Nuklearmedizin
    • Wien 1090 Austria
    • Cliniques Universitaires Saint-Luc
    • Brussels 1200 Belgium
    • Hôpital Erasme
    • Bruxelles 1070 Belgium
    • Cliniques Universitaires Saint-Luc
    • Bruxelles 1200 Belgium
    • Universitair Ziekenhuis Antwerpen (UZA)
    • Edegem 2650 Belgium
    • UZA - Apotheek
    • Edegem 2650 Belgium
    • UZ Gent
    • Gent 9000 Belgium
    • AZ Groeninge
    • Kortrijk 8500 Belgium
    • CHU de Liège
    • Liège 4000 Belgium
    • Foothills Medical Centre
    • Calgary Alberta T2N 2T9 Canada
    • Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
    • Calgary Alberta T2N 4N2 Canada
    • Cross Cancer Institute
    • Edmonton Alberta T6G 1Z2 Canada
    • British Columbia Cancer Agency - Sindi Ahluwalia Hawkins Centre for the Southern Interior
    • Kelowna British Columbia V1Y 5L3 Canada
    • British Columbia Cancer Agency
    • Vancouver British Columbia V5Z 4E6 Canada
    • CancerCare Manitoba
    • Winnipeg Manitoba R3E 0V9 Canada
    • London Regional Cancer Program, London Health Sciences Centre
    • London Ontario N6A 4L6 Canada
    • R.S. McLaughlin Durham Cancer Centre, Lakeridge Health
    • Oshawa Ontario L1G 2B9 Canada
    • R.S. McLaughlin Durham Regional Cancer Centre, Lakeridge Health
    • Oshawa Ontario L1G 2B9 Canada
    • Sunnybrook Research Institute
    • Toronto Ontario M4N 3M5 Canada
    • Jewish General Hospital
    • Montreal Quebec H3T 1E2 Canada
    • CIUSSS de l'Estrie-Centre hospitalier universitaire de Sherbrooke
    • Sherbrooke Quebec J1H 5N4 Canada
    • Herlev Hospital, Onkologisk Afdeling R
    • Herlev 2730 Denmark
    • Odense Universitetshospital
    • Odense C 5000 Denmark
    • Centre Eugene Marquis Service Pharmacie - Essais Cliniques
    • Rennes Cedex 35042 France
    • Centre FRANCOIS BACLESSE
    • CAEN cedex 05 14076 France
    • Centre Francois Baclesse
    • Caen, Cedex 05 14076 France
    • Clinique Victor Hugo - Centre Jean Bernard
    • Le Mans 72000 France
    • Clinique Victor Hugo
    • Le Mans 72000 France
    • Centre Léon Bérard
    • Lyon cedex 8 69008 France
    • Centre Léon Bérard
    • LYON cedex 8 69373 France
    • Institut Paoli Calmettes
    • Marseille 13009 France
    • Centre Eugene Marquis
    • Rennes cedex 35042 France
    • Institut de Cancérologie de l'Ouest - Centre René Gauducheau
    • Saint-Herblain Cedex 44805 France
    • Institut de Cancerologie de Lorraine (ICL)
    • Vandoeuvre les Nancy 54519 France
    • Institut de Cancerologie de Lorraine
    • Vandoeuvre les Nancy 54519 France
    • Institut Gustave Roussy
    • Villejuif 94805 France
    • Universitaetsklinikum Heidelberg
    • Heidelberg Baden-wuerttemberg 69120 Germany
    • Universitaetsklinikum Tuebingen
    • Tuebingen Baden-wuerttemberg 072076 Germany
    • Universitaetsklinikum Tuebingen
    • Tuebingen Baden-wuerttemberg 72076 Germany
    • Universitaetsklinikum Koeln
    • Koeln North Rhine-westphalia 50931 Germany
    • Universitaetsklinikum Koeln
    • Koeln North Rhine-westphalia 50937 Germany
    • Universitaetsklinikum Muenster
    • Muenster North Rhine-westphalia 48149 Germany
    • Universitaetsklinikum Jena
    • Jena Thuringia 07743 Germany
    • Universitaetsklinikum Jena Klinik und Poliklinik fuer Urologie
    • Jena Thuringia 07747 Germany
    • Universitaetsklinikum Jena
    • Jena Thuringia 07747 Germany
    • Egyesitett Szent Istvan es Szent Laszlo Korhaz - Rendelointezet
    • Budapest 1097 Hungary
    • Országos Onkológiai Intézet
    • Budapest 1122 Hungary
    • Uzsoki Utcai Korhaz
    • Budapest 1145 Hungary
    • Somogy Megyei Kaposi Mor Oktato Korhaz
    • Kaposvar 7400 Hungary
    • The Chaim Sheba Medical Center
    • Tel-Hashomer Ramat - GAN 5265601 Israel
    • Assaf Harofe MC
    • Beer Yaakov 70300 Israel
    • Rambam Health Care Campus
    • Haifa 31096 Israel
    • Rambam Healthcare Campus
    • Haifa 31096 Israel
    • Meir Medical Center
    • Kfar Saba 44281 Israel
    • Rabin Medical Center
    • Petach Tikva 49100 Israel
    • The Chaim Sheba Medical Center
    • Ramat - Gan 5265601 Israel
    • Pharmacy - clinical unit, Tel Aviv Sourasky Medical Center
    • Tel Aviv 6423906 Israel
    • Tel Aviv Sourasky Medical Center
    • Tel Aviv 6423906 Israel
    • Centro di Riferimento Oncologico - IRCCS
    • Aviano (pn) 33081 Italy
    • S.O.C. di Farmacia
    • Aviano (pn) 33081 Italy
    • Farmacia Studi Clinici
    • Rozzano Milan 20089 Italy
    • Istituto Clinico Humanitas
    • Rozzano Milan 20089 Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori
    • Milan 20133 Italy
    • SC Farmacia
    • Milan 20133 Italy
    • Istituto Europeo di Oncologia
    • Milan 20141 Italy
    • Servizio di Farmacia
    • Milan 20141 Italy
    • Azienda Ospedaliera San Camillo Forlanini
    • Rome 00152 Italy
    • U.O.C. Farmacia
    • Rome 00152 Italy
    • Nagoya University Hospital
    • Nagoya Aichi 466-8560 Japan
    • Hirosaki University School of Medicine & Hospital
    • Hirosaki Aomori 036-8563 Japan
    • Hokkaido University Hospital
    • Sapporo Hokkaidô 060-8648 Japan
    • Iwate Medical University
    • Morioka Iwate 020-8505 Japan
    • Yokohama City University Hospital
    • Yokohama Kanagawa 236-0004 Japan
    • Kindai University Hospital
    • Osakasayama Osaka 589-8511 Japan
    • Osaka University Hospital
    • Suita Osaka 565-0871 Japan
    • Hamamatsu University School of Medicine, University Hospital
    • Hamamatsu Shizuoka 431-3192 Japan
    • Keio University Hospital
    • Shinjuku-ku Tokyo 160-8582 Japan
    • Tokyo Women's Medical University Hospital
    • Shinjuku-ku Tokyo 162-8666 Japan
    • Akita University Hospital
    • Akita 010-8543 Japan
    • Chiba Cancer Center
    • Chiba 260-8717 Japan
    • Kyushu University Hospital
    • Fukuoka 812-8582 Japan
    • Niigata University Medical & Dental Hospital
    • Niigata 951-8520 Japan
    • Tokushima University Hospital
    • Tokushima 770-8503 Japan
    • Yamagata University Hospital
    • Yamagata 990-9585 Japan
    • Clinical Trial Pharmacy, National Cancer Center
    • Goyang-si Gyeonggi-do 10408 Korea, Republic of
    • National Cancer Center
    • Goyang-Si Gyeonggi-do 10408 Korea, Republic of
    • Seoul National University Bundang Hospital, Clinical Pharmacy
    • Seongnam-si Gyeonggido 13620 Korea, Republic of
    • Seoul National University Bundang Hospital
    • Seongnam-si Gyeonggido 13620 Korea, Republic of
    • Kyungpook National University Medical Center, Clinical Pharmacy
    • Daegu 41404 Korea, Republic of
    • Kyungpook National University Medical Center
    • Daegu 41404 Korea, Republic of
    • Chungnam National University Hospital, Clinical Pharmacy
    • Daejeon 35015 Korea, Republic of
    • Chungnam National University Hospital
    • Daejeon 35015 Korea, Republic of
    • Seoul National University Hospital, Clinical Pharmacy
    • Seoul 03080 Korea, Republic of
    • Seoul National University Hospital
    • Seoul 03080 Korea, Republic of
    • Severance Hospital, Yonsei University Health System, Clinical Pharmacy
    • Seoul 03722 Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Seoul 03722 Korea, Republic of
    • Asan Medical Center
    • Seoul 05505 Korea, Republic of
    • Clinical Trail Pharmcy
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center Clinical Trial Pharmacy
    • Seoul 06351 Korea, Republic of
    • Samsung Medical Center
    • Seoul 06351 Korea, Republic of
    • Instituto Nacional de Cancerologia
    • Mexico Ciudad DE Mexico 14080 Mexico
    • Hospital Universitario Dr. Jose Eleuterio Gonzalez, Centro Universitario Contra el Cancer
    • Monterrey Nuevo LEON 64460 Mexico
    • Oaxaca Site Management Organization S.C.
    • Oaxaca 68000 Mexico
    • Netherlands Cancer Institute/Antoni van Leeuwenhoek Hospital
    • Amsterdam Noord-holland 1066 CX Netherlands
    • Netherlands Cancer Institute / Apotheek MC Slotervaart
    • Amsterdam Noord-holland 1066 EC Netherlands
    • VU University Medical Center (VUmc)
    • Amsterdam Noord-holland 1081 BT Netherlands
    • VU University Medical Center (VUmc)
    • Amsterdam Noord-holland 1081 HZ Netherlands
    • Sint Franciscus Gasthuis, Pharmacy
    • Rotterdam Zuid-holland 3045 PM Netherlands
    • Sint Franciscus Gasthuis
    • Rotterdam Zuid-holland 3045 PM Netherlands
    • Maxima Medisch Centrum
    • Eindhoven 5631 BM Netherlands
    • St Apotheek der Haarlemse Ziekenhuizen
    • Haarlem 2035 RC Netherlands
    • Spaarne Gasthuis
    • Hoofddorp 2134 TM Netherlands
    • Maastricht University Medical Center
    • Maastricht 6229 HX Netherlands
    • Maxima Medisch Centrum
    • Veldhoven 5504 DB Netherlands
    • Maxima Medisch Centrum
    • Veldhoven 5504 DL Netherlands
    • Auckland City Hospital
    • Grafton Auckland 1023 New Zealand
    • Tauranga Hospital, Bay of Plenty Clinical Trials Unit
    • Tauranga BAY OF Plenty 3143 New Zealand
    • Palmerston North Hospital
    • Palmerston North Manawatu-wanganui 4414 New Zealand
    • Tauranga Hospital
    • Tauranga Bay Of Plenty Tauranga 3112 New Zealand
    • Auckland City Hospital Pharmacy
    • Auckland 1023 New Zealand
    • Baxter Healthcare New Zealand
    • Auckland 1060 New Zealand
    • Christchurch Hospital
    • Christchurch 8140 New Zealand
    • Waikato Hospital Pharmacy Services
    • Hamilton 3240 New Zealand
    • Waikato Hospital
    • Hamilton 3240 New Zealand
    • Broadway Radiology
    • Palmerston North 4410 New Zealand
    • "Prof. Dr. Ion Chiricuta" Oncology Institute
    • Cluj-Napoca 400015 Romania
    • S.C. Medisprof S.R.L.
    • Cluj-Napoca 400058 Romania
    • "Sfantul Nectarie" Oncology Center
    • Craiova 200347 Romania
    • Oncomed SRL
    • Timisoara 300239 Romania
    • "Pius Brînzeu" Emergency Clinical County Hospital
    • Timisoara 300736 Romania
    • FSBI "National Medical Radiology Research Center" of MoH of RF
    • Obninsk Kaluga Region 249036 Russian Federation
    • RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR (legal address)
    • Kursk Kursk Region 305035 Russian Federation
    • RBHI "Kursk Regional Clinical Oncology Dispensary" of HCKR
    • Kursk Kursk Region 305524 Russian Federation
    • FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF (IP shipment)
    • Saint-Petersburg Poselok Pesochniy 197758 Russian Federation
    • FSBI "Research Institute of Oncology n.a. N.N. Petrov" MoH RF
    • Saint-Petersburg Poselok Pesochniy 197758 Russian Federation
    • Private medical institution "Euromedservice"
    • Pushkin Saint-petersburg 196603 Russian Federation
    • Moscow Scientific Research Oncology Institute n.a. P.A. Hertzen
    • Moscow 125284 Russian Federation
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
    • Nizhniy Novgorod 603001 Russian Federation
    • SBIH of Nizhegorodskaya region "Clinical-Diagnostics center"
    • Nizhniy Novgorod 603006 Russian Federation
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
    • Nizhniy Novgorod 603032 Russian Federation
    • FBIH "Privolzhskiy Regional Medical Center" of FMBA
    • Nizhniy Novgorod 603109 Russian Federation
    • SBIH of Nizhegorodskaya region "Nizhniy Novgorod Regional Clinical Oncology Dispensary"
    • Nizhniy Novgorod 603126 Russian Federation
    • NS HI "Road Clinical Hospital of JSC "Russian Railways""
    • Saint Petersburg 195271 Russian Federation
    • SHI YR Regional Clinical Oncology Hospital
    • Yaroslavl 150040 Russian Federation
    • Clinica Universidad de Navarra
    • Pamplona Navarra 31008 Spain
    • Gabinete Radiologico Doctor Pita
    • Madrid 28006 Spain
    • Hospital Universitario Ramon y Cajal
    • Madrid 28034 Spain
    • Hospital Universitario Ramón y Cajal
    • Madrid 28034 Spain
    • Hospital Universitario 12 de Octubre
    • Madrid 28041 Spain
    • Hospital Universitario Virgen del Rocio
    • Sevilla 41013 Spain
    • Sahlgrenska University Hospital, Dept of Oncology
    • Gothenburg 413 45 Sweden
    • Cambridge University Hospital NHS Foundation Trust, Addenbrooke's Hospital
    • Cambridge Cambridgeshire CB2 0QQ United Kingdom
    • Mount Vernon Cancer Centre, East & North Herts NHS Trust
    • London Middlesex HA6 2RN United Kingdom
    • Mount Vernon Cancer Centre, Pharmacy
    • Northwood Middlesex HA6 2RN United Kingdom
    • The Royal Marsden NHS Foundation Trust
    • Sutton Surrey, London SM2 5PT United Kingdom
    • The Royal Marsden NHS Foundation Trust
    • Sutton Surrey SM2 5PT United Kingdom
    • Addenbrooke's Hospital, Central Pharmacy, Level 1
    • Cambridge CB2 0QQ United Kingdom
    • Beatson WOSCC
    • Glasgow G12 0YN United Kingdom
    • Beatson West of Scotland Cancer Centre, Gartnavel General Hospital,
    • Glasgow G120YN United Kingdom
    • St Bartholomew's Hospital, Barts Health NHS Trust
    • London EC1A 7BE United Kingdom
    • The Royal Marsden NHS Foundation Trust
    • London SW3 6JJ United Kingdom
    • Clinical Trials Pharmacy, The Christie
    • Manchester M20 4BX United Kingdom
    • Department of Medical Oncology, The Christie NHS Foundation Trust
    • Manchester M20 4BX United Kingdom
    • Academic Unit of Oncology, Nottingham University Hospitals NHS Trust-City Campus
    • Nottingham NG5 1PB United Kingdom
    • Nottingham University Hospitals, Nottingham City Hospital, Nottingham Trials Pharmacy
    • Nottingham NG5 1PB United Kingdom

    View trial on ClinicalTrials.gov


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    Published June 8, 2017
  • A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen

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    A Phase II Safety Trial of Nivolumab in Patients With Metastatic Renal Cell Carcinoma Who Have Progresses During or After Prior Systemic Anti-angiogenic Regimen


    Condition: Metastatic Renal Cell Carcinoma

    Intervention:

    • Drug: Nivolumab

    Purpose: The primary objective of this study is to evaluate the incidence of high-grade (i.e. Grade 3-4 and Grade 5 of CTCAE v4.0) adverse reactions of interest in patients with metastatic RCC who have progressed during or after receiving at least one prior systemic anti-angiogenic treatment and who are eligible for nivolumab monotherapy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03013335

    Sponsor: UNICANCER

    Primary Outcome Measures:

    • Measure: Incidence for high-grade (Grade3-4-5) adverse reactions of interest
    • Time Frame: 5 years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Assessment of Overall Survival (OS) by Follow-up continued
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Number of patients with a Best Overall Response (BOR) by RECIST v1.1
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Percentage of patients who received immune modulating concomitant medication
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Percentage of patients who received hormonal replacement therapy
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Median time to resolution of adverse reactions of interest
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Assessment of quality of life by questionnaire FACT-G
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Assessment of quality of life by questionnaire FKSI-19
    • Time Frame: 5 years
    • Safety Issue:
    • Measure: Assessment of quality of life by questionnaire EQ-5D
    • Time Frame: 5 years
    • Safety Issue:

    Estimated Enrollment: 450

    Study Start Date: January 2016

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    1. Adult men and women ≥ 18 years.
    2. Patients with a histologically confirmed Renal Cell Carcinoma with a clear-cell component
    3. Patients with metastatic (AJCC stage IV) Renal Cell Carcinoma, with at least one measurable lesion by CT Scan or MRI according to RECIST 1.1 or with clinically apparent disease that can be reliably monitored by the investigator.
    4. Patients having received at least one prior systemic anti-angiogenic treatment including but not limited to: sunitinib, sorafenib, pazopanib, axitinib, and bevacizumab, in the advanced or metastatic setting. Prior cytokine therapies (e.g. IL-2, IFN-α), vaccine therapy or treatment with cytotoxics are allowed. Patients intolerant to prior systemic anti-angiogenic treatment can also be eligible (except hypersensitivity to other monoclonal antibodies). A maximum of 25% of patients with more than 2 prior systemic treatments will be recruited per sites.
    5. Patients with Eastern Cooperative Oncology Group (ECOG) performance status ≤
    6. (Appendix 3)
    7. Favorable, intermediate or poor risk group patients measured by the IMDC model (Appendix 2).
    8. Patients with brain metastases will be eligible if they are: asymptomatic, without edema, not on corticosteroids, not be eligible for radiation therapy/surgery and not receiving active treatments.
    9. Patients who have progressed following radiation therapy. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids, except replacement organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks prior to the first nivolumab administration.
    10. Potentially reproductive patients must agree to use an effective contraceptive method or practice adequate methods of birth control or practice complete abstinence while on treatment, and for at least 31 weeks (≈ 7 months) for males and 23 weeks (≈ 5 months) for females after the last dose of study drug. Azoospermic males and women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
    11. Women of childbearing potential must have a negative serum pregnancy test done within 24 hours prior to the first dosing.
    12. Women who are breastfeeding should discontinue nursing prior to the first dose of study drug and until 6 months after the last dose.
    13. Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses.
    14. Patients with social insurance coverage.

    Exclusion Criteria:

    • 1. Patients with any active autoimmune disease or a history of known autoimmune disease (Patients with type I diabetes mellitus, residual hypothyroidism due to an autoimmune condition requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are however eligible for this trial). 2. Patients with uncontrolled adrenal insufficiency. 3. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). 4. Patients with positive tests for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. 5. Patients having received prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways). 6. Patients having received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal (influenza) vaccinations within 4 weeks of the first dose of study drug. 7. Patients receiving anti-cancer therapies must be discontinued at least 2 weeks prior to administration of study drug. Palliative, focal radiation therapy, and immunosuppressive doses of systemic corticosteroids, except replacement organotherapy (hydrocortisone and fludrocortisone), must be discontinued at least 2 weeks before administration of study drug. All toxicities attributed to prior anti-cancer therapy other than alopecia must have resolved to grade 1 (NCI CTCAE version 4) or baseline before administration of study drug. 8. Patients with other prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast. 9. Patients with altered hematopoietic or organ function, as indicated by the following criteria (assessed within -14 days prior the first dosing):
    • WBC < 2000/µL
    • Polynuclear neutrophils < 1.5 x 109/L
    • Platelets < 100 x 109/L
    • Hemoglobin < 8.0 g/mL
    • ALAT/ASAT > 3.0 x ULN in the absence of liver metastases or > 5x ULN in the presence of liver metastases
    • Bilirubin > 1.5 x ULN (except Gilbert Syndrome : < 3.0 mg/dL)
    • Creatinine clearance ≤ 40 mL/min (measured or calculated by Cockroft and Gault formula) or serum creatinine > 2.0 x ULN 10. Patients with a history of hypersensitivity to other monoclonal antibodies or to the active or inactive excipients of study drug. 11. Known drug or alcohol abuse. 12. Known or underlying medical condition (e.g., a condition associated with diarrhea or acute diverticulitis) that, in the investigator's opinion, would make the administration of study drug hazardous to the patient or obscure the interpretation of toxicity determination or adverse events. 13. History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant, precluding informed consent, or interfering with compliance of oral drug intake. 14. Unwillingness to give written informed consent, unwillingness to participate, or inability to comply with the protocol for the duration of the study. 15. Individuals deprived of liberty or placed under the authority of a tutor. 16. Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment and during the treatment period

    Contact:

    • Muriel HABIBIAN
    • +33 (0) 1 76 64 78 07

    Locations:

    • Centre Francois Baclesse
    • Caen 14076 France
    • Centre Georges-Francois Leclerc
    • Dijon 21079 France
    • Centre Leon Berard
    • Lyon 69373 France
    • Institut Paoli-Calmettes
    • Marseille 13273 Cedex 9 France
    • Centre Antoine Lacassagne
    • Nice 06189 Cedex 2 France
    • Institut de Cancerologie de Lorraine
    • Vandoeuvre Les Nancy 54500 France
    • Gustave Roussy Cancer Campus Grand Paris
    • Villejuif 94800 France

    View trial on ClinicalTrials.gov


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    Published June 2, 2018
  • A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE

    {{header-clinical-trials-navigation}}

    A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)


    Condition: Renal Cell Carcinoma

    Intervention:

    • Biological: Pembrolizumab
    • Drug: Axitinib
    • Drug: Sunitinib

    Purpose: The purpose of this study is to evaluate the efficacy and safety of pembrolizumab (MK-3475) in combination with axitinib versus sunitinib monotherapy as a first-line treatment for participants with advanced/metastatic renal cell carcinoma (mRCC). The primary hypotheses of this study are: 1) The combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Progression-Free Survival (PFS) as assessed by blinded independent central imaging review per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) and 2) the combination therapy of pembrolizumab plus axitinib is superior to sunitinib monotherapy with respect to Overall Survival (OS).

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02853331

    Sponsor: Merck Sharp & Dohme Corp.

    Primary Outcome Measures:

    • Measure: Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Imaging Review
    • Time Frame: Up to approximately 2 years
    • Safety Issue:
    • Measure: Overall Survival (OS)
    • Time Frame: Up to approximately 39 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review
    • Time Frame: Up to approximately 2 years
    • Safety Issue:
    • Measure: Disease Control Rate (DCR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review
    • Time Frame: Up to approximately 2 years
    • Safety Issue:
    • Measure: Number of Participants Who Experience an Adverse Event (AE)
    • Time Frame: Up to approximately 39 months
    • Safety Issue:
    • Measure: Number of Participants Who Discontinue Study Drug Due to an AE
    • Time Frame: Up to approximately 39 months
    • Safety Issue:
    • Measure: Duration of Response (DOR) Per RECIST 1.1 as Assessed by Blinded Independent Central Imaging Review
    • Time Frame: Up to approximately 2 years
    • Safety Issue:

    Estimated Enrollment: 840

    Study Start Date: September 16, 2016

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features.
    • Has locally advanced/metastatic disease (i.e., newly diagnosed Stage IV RCC per American Joint Committee on Cancer) or has recurrent disease.
    • Has measurable disease per RECIST 1.1 as assessed by the investigator/site radiologist.
    • Has received no prior systemic therapy for advanced RCC.
    • Has provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated.
    • Has Karnofsky performance status (KPS) ≥ 70% as assessed within 10 days prior to randomization.
    • If receiving bone resorptive therapy (including but not limited to bisphosphonate or RANK-L inhibitor) must have therapy initiated at least 2 weeks prior to randomization.
    • Demonstrates adequate organ function.
    • Female participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug.
    • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study drug through 120 days after the last dose of study drug.

    Exclusion Criteria:

    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization.
    • Has had major surgery within 4 weeks, received radiation therapy within 2 weeks prior to randomization, or has not recovered (i.e., ≤ Grade 1 or at baseline) from AEs due to prior treatment.
    • Has had prior treatment with any anti-programmed cell death (anti-PD-1), or programmed cell death ligand 1 (PD-L1), or PD-L2 agent or an antibody targeting any other immune-regulatory receptors or mechanisms.
    • Has received prior systemic anti-cancer therapy for RCC with vascular endothelial growth factor (VEGF)/VEGF receptors (VEGFR) or mechanistic target of rapamycin (mTOR) targeting agents.
    • Has a history of severe hypersensitivity reaction (e.g., generalized rash/erythema, hypotension, bronchospasm, angioedema or anaphylaxis) to axitinib or sunitinib.
    • Has a diagnosis of immunodeficiency OR is receiving a systemic steroid therapy exceeding physiologic corticosteroid dose or any other form of immunosuppressive therapy within 7 days prior to randomization, except in the case of central nervous system (CNS) metastases.
    • Has an active autoimmune disease requiring systemic treatment with in the past 2 years OR a documented history of clinically severe autoimmune disease. Note: Participants with vitiligo, Sjøgren's syndrome, Type 1 diabetes, resolved childhood asthma/atopy, hypothyroidism or adrenal or pituitary insufficiency who are stable on hormone replacement, are not excluded.
    • Has a known additional malignancy that has progressed or has required active treatment in the last 3 years. Note: Basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer in situ are acceptable if they have undergone potentially curative therapy.
    • Has known active CNS metastases and/or carcinomatous meningitis.
    • Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.
    • Has an active infection requiring systemic therapy.
    • Has a known history of Human Immunodeficiency Virus (HIV).
    • Has known active Hepatitis B or Hepatitis C infection.
    • Has received a live virus vaccine within 30 days of randomization.
    • Has a clinically significant gastrointestinal (GI) abnormality including:
    • Malabsorption, total gastric resection
    • Or any condition that might affect the absorption of orally taken medication
    • Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy
    • Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation
    • Has QT interval corrected for heart rate (QTc) ≥480 msec.
    • Has a history of any of the following cardiovascular conditions within 12 months of randomization:
    • Myocardial infarction
    • Unstable angina pectoris
    • Cardiac angioplasty or stenting
    • Coronary/peripheral artery bypass graft
    • Class III or IV congestive heart failure per New York Heart Association
    • Cerebrovascular accident or transient ischemic attack
    • Has a history of deep vein thrombosis or pulmonary embolism within 6 months of screening.
    • Has poorly controlled hypertension defined as systolic blood pressure (SBP) ≥150 mm Hg and/or diastolic blood pressure (DBP) ≥90 mm Hg.
    • Has evidence of inadequate wound healing.
    • Has active bleeding disorder or other history of significant bleeding episodes within 30 days of randomization.
    • Has hemoptysis within 6 weeks prior to randomization.
    • Has current use (within 7 days of randomization) or anticipated need for treatment with drugs or foods that are known strong cytochrome P450 (CYP3A4/5) inhibitors.
    • Has current use (within 7 days of randomization) or anticipated need for treatment with drugs that are known strong CYP3A4/5 inducers, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, and St. John's wort; or drugs that are known with proarrhythmic potential.
    • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.
    • Has had a prior solid organ transplant.
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug.

    Contact:

    • Toll Free Number
    • 1-888-577-8839

    Locations:

    • Call for Information (Investigational Site 0086)
    • Orange California 92868 United States
    • Call for Information (Investigational Site 8001)
    • Denver Colorado 80218 United States
    • Call for Information (Investigational Site 0095)
    • Washington District of Columbia 20007 United States
    • Call for Information (Investigational Site 0091)
    • Marietta Georgia 30060 United States
    • Call for Information (Investigational Site 0078)
    • Chicago Illinois 60611 United States
    • Call for Information (Investigational Site 0041)
    • Chicago Illinois 60612 United States
    • Call for Information (Investigational Site 0035)
    • New Orleans Louisiana 70121 United States
    • Call for Information (Investigational Site 0046)
    • Lincoln Nebraska 68510 United States
    • Call for Information (Investigational Site 0088)
    • Buffalo New York 14263 United States
    • Call for Information (Investigational Site 0032)
    • New York New York 10016 United States
    • Call for Information (Investigational Site 0020)
    • Rochester New York 14642 United States
    • Call for Information (Investigational Site 0087)
    • Charlotte North Carolina 28204 United States
    • Call for Information (Investigational Site 0805)
    • Cleveland Ohio 44111 United States
    • Call for Information (Investigational Site 0009)
    • Cleveland Ohio 44195 United States
    • Call for Information (Investigational Site 0806)
    • Mayfield Heights Ohio 44124 United States
    • Call for Information (Investigational Site 0037)
    • Portland Oregon 97239 United States
    • Call for Information (Investigational Site 8010)
    • Tualatin Oregon 97062 United States
    • Call for Information (Investigational Site 0093)
    • Allentown Pennsylvania 18103 United States
    • Call for Information (Investigational Site 0013)
    • Philadelphia Pennsylvania 19111 United States
    • Call for Information (Investigational Site 0062)
    • Pittsburgh Pennsylvania 15232 United States
    • Call for Information (Investigational Site 8004)
    • Charleston South Carolina 29414 United States
    • Call for Information (Investigational Site 0089)
    • Sioux Falls South Dakota 57104 United States
    • Call for Information (Investigational Site 0090)
    • Chattanooga Tennessee 37403 United States
    • Call for Information (Investigational Site 0070)
    • Germantown Tennessee 38138 United States
    • Call for Information (Investigational Site 0064)
    • Dallas Texas 75390 United States
    • Call for Information (Investigational Site 8002)
    • Houston Texas 77024 United States
    • Call for Information (Investigational Site 8003)
    • San Antonio Texas 78217 United States
    • Call for Information (Investigational Site 0072)
    • Salt Lake City Utah 84106 United States
    • Call for Information (Investigational Site 0082)
    • Fairfax Virginia 22031 United States
    • MSD Brasil
    • Sao Paulo Brazil
    • Merck Canada
    • Kirkland Quebec H9H 4M7 Canada
    • MSD SRO Czech
    • Prague Prague 6 Czechia
    • MSD France
    • Paris France
    • MSD Ireland (Human Health) Ltd.
    • Dublin Ireland
    • MSD K.K.
    • Chiyoda-Ku, Tokyo 102-8667 Japan
    • MSD Korea LTD
    • Seoul 4130 Korea, Republic of
    • MSD Polska Sp. Z o.o.
    • Warsaw Poland
    • Merck Sharp and Dohme de Espana S.A.
    • Madrid Spain
    • MSD Ukraine LLC
    • Kiev Ukraine
    • Merck Sharp & Dohme Ltd.
    • Hoddesdon United Kingdom

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 8, 2017
  • A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy

    {{header-clinical-trials-navigation}}

    A Phase III, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study of Atezolizumab (Anti−PD-L1 Antibody) as Adjuvant Therapy in Patients With Renal Cell Carcinoma at High Risk of Developing Metastasis Following Nephrectomy


    Condition: Renal Cell Carcinoma

    Intervention:

    • Drug: Atezolizumab
    • Other: Placebo

    Purpose: This is a Phase III, multicenter, randomized, placebo-controlled, double-blind study to evaluate the efficacy and safety of atezolizumab versus placebo in participants with RCC who are at high risk of disease recurrence following nephrectomy.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03024996

    Sponsor: Hoffmann-La Roche

    Primary Outcome Measures:

    • Measure: IRF-assessed Disease-Free Survival (DFS)
    • Time Frame: From Baseline until first documented recurrence event (up to approximately 88 months)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall Survival
    • Time Frame: From Baseline up to death due to any cause (up to approximately 88 months)
    • Safety Issue:
    • Measure: Investigator-assessed DFS
    • Time Frame: From Baseline up to first occurence of event by investigator assessment (up to approximately 88 months)
    • Safety Issue:
    • Measure: IRF-assessed DFS in Participants With Tumor-Infiltrating Immune Cell (IC) 1/2/3
    • Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months)
    • Safety Issue:
    • Measure: Investigator-assessed DFS in Participants With Tumor-Infiltrating IC 1/2/3
    • Time Frame: From Baseline until first occurrence of DFS event (up to approximately 88 months)
    • Safety Issue:
    • Measure: Disease-Specific Survival
    • Time Frame: From Baseline up to death due to RCC (up to approximately 88 months)
    • Safety Issue:
    • Measure: Distant Metastasis-Free Survival
    • Time Frame: From Baseline up to date of diagnosis of distant metastases or death due to any cause (up to approximately 88 months)
    • Safety Issue:
    • Measure: Percentage of Participants Who Are Alive and IRF-assessed Recurrence Free at Year 3
    • Time Frame: Year 3
    • Safety Issue:
    • Measure: Percentage of Participants Who Are Alive and Investigator-assessed Recurrence Free at Year 3
    • Time Frame: Year 3
    • Safety Issue:
    • Measure: Percentage of Participants With Adverse Events
    • Time Frame: From Baseline up to 90 days after last dose of study drug or until initiation of new systemic anti-cancer therapy, whichever occurs first (last dose = up to approximately 1 year)
    • Safety Issue:
    • Measure: Maximum Serum Concentration (Cmax) of Atezolizumab
    • Time Frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
    • Safety Issue:
    • Measure: Minimum Serum Concentration (Cmin) of Atezolizumab
    • Time Frame: Predose (Hour[hr]0), 0.5 hr after end of infusion (infusion duration=1 hr) on Cycle 1 Day 1; predose (hr 0) on Day 1 of Cycles 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
    • Safety Issue:
    • Measure: Percentage of Participants With Anti-Therapeutic Antibodies (ATA) to Atezolizumab
    • Time Frame: Predose (hr 0) on Day 1 of Cycles 1, 2, 3, 4, 8; at treatment discontinuation (up to 1 year); 90-120 days after last dose (last dose = up to 1 year) (Cycle=21 days)
    • Safety Issue:

    Estimated Enrollment: 664

    Study Start Date: January 3, 2017

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • ECOG performance status of less than or equal to (
    • Pathologically confirmed RCC with a component of either clear cell histology or sarcomatoid histology that has not been previously treated in the adjuvant or neoadjuvant setting and classified as being at high risk of RCC recurrence
    • Radical or partial nephrectomy with lymphadenectomy in select participants
    • Absence of residual disease and absence of metastasis, as confirmed by a negative baseline computed tomography (CT) of the pelvis, abdomen, and chest no more than 4 weeks prior to randomization. Confirmation of disease-free status will be assessed by an independent central radiologic review of imaging data.
    • Absence of brain metastasis, as confirmed by a negative CT with contrast or magnetic resonance imaging (MRI) scan of the brain, no more than 4 weeks prior to randomization. Applicable only to metastasectomy participants
    • Full recovery from nephrectomy or metastasectomy within 12 weeks from randomization following surgery

    Exclusion Criteria:

    • Bilateral synchronous tumors with inheritable forms of RCC including von Hippel-Lindau
    • Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment
    • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days or five half-lives of the investigational agent, whichever is longer, prior to enrollment
    • Malignancies other than RCC within 5 years prior to Cycle 1, Day 1
    • History of autoimmune disease
    • Participants with prior allogeneic stem cell or solid organ transplantation
    • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan
    • Positive test for HIV
    • Participants with active hepatitis B or hepatitis C
    • Active tuberculosis
    • Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
    • Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
    • Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the participant at high risk from treatment complications
    • Prior treatment with cluster of differentiation (CD)137 agonists, anti-cytotoxic T-lymphocyte-associated protein-4 (anti-CTLA-4), anti-programmed death-1 (anti-PD−1), or anti-programmed death-ligand 1 (anti-PD-L1) therapeutic antibody or pathway-targeting agents
    • Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin-2) within 6 weeks or five half-lives of the drug, whichever is shorter, prior to randomization
    • Treatment with systemic immunosuppressive medications (including but not limited to corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis factor agents) within 2 weeks prior to randomization or anticipated need for systemic immunosuppressive medications during the study

    Contact:

    • Reference Study ID Number: WO39210 www.roche.com/about_roche/roche_worldwide.htm
    • 888-662-6728 (U.S. and Canada)

    Locations:

    • Banner MD Anderson Cancer Center
    • Gilbert Arizona 85234 United States
    • Mayo Clinic- Scottsdale
    • Scottsdale Arizona 85259 United States
    • City of Hope National Medical Center
    • Duarte California 91010 United States
    • Moores Cancer Center at UC San Diego Health
    • La Jolla California 92093 United States
    • City of Hope, Antelope Valley
    • Lancaster California 93534 United States
    • Cedars-Sinai Medical Center
    • Los Angeles California 90048 United States
    • UCLA Urology; Urology
    • Los Angeles California United States
    • University of California Irvine Medical Center
    • Orange California 92868 United States
    • City of Hope; Rancho Cucamonga
    • Rancho Cucamonga California 91730 United States
    • City of Hope-South Pasadena
    • South Pasadena California 91030 United States
    • University of Colorado Cancer Center
    • Aurora Colorado 80045 United States
    • The Urology Center of Colorado
    • Denver Colorado 80211 United States
    • Yale School of Medicine
    • New Haven Connecticut 06510 United States
    • Florida Cancer Specialists-Broadway, Fort Myers
    • Fort Myers Florida 33908 United States
    • University of Florida
    • Gainesville Florida 32607 United States
    • Mayo Clinic-Jacksonville
    • Jacksonville Florida 32224 United States
    • Univ of Miami, School of Med; Hem/Onc
    • Miami Florida 33136 United States
    • Moffitt Cancer Center
    • Tampa Florida 33647 United States
    • Emory Uni - Winship Cancer Center; Hematology/Oncology
    • Atlanta Georgia 30322 United States
    • Emory University Clinic
    • Atlanta Georgia 30322 United States
    • The University of Chicago Biological Sciences; Dept. of Medicine, Section of Hematology/Oncology
    • Chicago Illinois 60637 United States
    • Loyola University Medical Center, Cardinal Bernardin Cancer Center
    • Maywood Illinois 60151 United States
    • University of Iowa Hospitals & Clinics; Internal Medicine
    • Iowa City Iowa 52242 United States
    • Norton Cancer Institute
    • Louisville Kentucky 40202 United States
    • Tulane Uni Health Sciences Center
    • New Orleans Louisiana 70112 United States
    • Ochsner Clinic Foundation
    • New Orleans Louisiana 70121 United States
    • New England Cancer Specialists
    • Scarborough Maine 04074 United States
    • Chesapeake Urology Research Associates
    • Towson Maryland 21204 United States
    • Mayo Clinic - Rochester
    • Rochester Minnesota 55905 United States
    • Sarah Cannon Research Institute - Kansas City - HCA Midwest Health
    • Kansas City Missouri 64132 United States
    • Southeast Nebraska Cancer Center;; Southeast Nebraska Hematology and Oncology
    • Lincoln Nebraska 68510 United States
    • Garden State Urology
    • Whippany New Jersey United States
    • New York Oncology Hematology at Albany Medical Center
    • Albany New York 12208 United States
    • New York Oncology Hematology, P.C.
    • Albany New York 12208 United States
    • Bellevue Hospital
    • New York New York 10016 United States
    • Laura and ISAAC Perlmutter Cancer Center at NYU Langone.
    • New York New York 10016 United States
    • Mount SInai Medical Center
    • New York New York 10029 United States
    • Columbia University Medical Center
    • New York New York 10032 United States
    • University of Rochester Medical Center; Urology
    • Rochester New York 14642 United States
    • Stony Brook University Medical Center
    • Stony Brook New York 11794 United States
    • SUNY Upstate Medical University
    • Syracuse New York 13210 United States
    • University of North Carolina at Chapel Hill
    • Chapel Hill North Carolina 27514 United States
    • Levine Cancer Institute
    • Charlotte North Carolina 28204 United States
    • Duke Cancer Center
    • Durham North Carolina 27710 United States
    • Fairview Hospital; Cleveland Clinic Cancer Center
    • Cleveland Ohio 44111 United States
    • Cleveland Clinic Foundation; Hematology and Oncology
    • Cleveland Ohio 44195 United States
    • Hillcrest Hospital; Hirsch Cancer Center
    • Mayfield Heights Ohio 44124 United States
    • University of Oklahoma; Stephenson Oklahoma Canc Ctr
    • Oklahoma City Oklahoma 73104 United States
    • Oregon Health & Science Uni
    • Portland Oregon 97239 United States
    • Penn State Hershey Cancer Institute
    • Hershey Pennsylvania 17033 United States
    • Lancaster Urology
    • Lancaster Pennsylvania 17604 United States
    • Thomas Jefferson University Hospital;Medical Oncology
    • Philadelphia Pennsylvania 19107 United States
    • Fox Chase Cancer Center; Hematology/Oncology
    • Philadelphia Pennsylvania 19111 United States
    • UPMC Cancer Centers
    • Pittsburgh Pennsylvania 15232 United States
    • Carolina Urologic Research Center
    • Myrtle Beach South Carolina 29572 United States
    • Sanford Cancer Cnt Onco Clinic
    • Sioux Falls South Dakota 57104 United States
    • Erlanger Health Systems
    • Chattanooga Tennessee 37403 United States
    • Urology Associates of Kingsport, P.C.
    • Kingsport Tennessee United States
    • Sarah Cannon Research Institute
    • Nashville Tennessee 37203 United States
    • Vanderbilt University Medical Center; Vanderbilt University
    • Nashville Tennessee 37232 United States
    • University of Texas Southwestern Medical Center
    • Dallas Texas 75390 United States
    • MD Anderson Cancer Center
    • Houston Texas 77030-4095 United States
    • University of Utah; Huntsman Cancer Hospital
    • Salt Lake City Utah 84112 United States
    • Seattle Cancer Care Alliance
    • Seattle Washington 98109 United States
    • West Virginia University Hospitals Inc
    • Morgantown West Virginia 26056 United States
    • Hospital Britanico; Oncologia
    • Buenos Aires C1280AEB Argentina
    • Hospital Aleman
    • Caba C1118AAT Argentina
    • Centro Oncologico Riojano Integral (CORI)
    • La Rioja F5300COE Argentina
    • Calvary Mater Newcastle; Medical Oncology
    • Waratah New South Wales 2298 Australia
    • Royal Brisbane & Women's Hosp; Cancer Care Serv
    • Herston Queensland 4029 Australia
    • Ashford Cancer Center Research
    • Kurralta Park South Australia 5037 Australia
    • Austin Hospital; Medical Oncology
    • Heidelberg Victoria 3084 Australia
    • LKH-UNIV. KLINIKUM GRAZ; Klinische Abteilung für Onkologie
    • Graz 8036 Austria
    • Ordensklinikum Linz Elisabethinen; Abteilung für Urologie und Andrologie
    • Linz 4020 Austria
    • Landeskrankenhaus Salzburg; Universitätsklinik für Urologie und Andrologie der PMU
    • Salzburg 5020 Austria
    • Medizinische Universität Wien; Univ.Klinik für Innere Medizin I
    • Wien 1090 Austria
    • Cliniques Universitaires St-Luc
    • Bruxelles 1200 Belgium
    • Grand Hôpital de Charleroi Notre Dame
    • Charleroi 6000 Belgium
    • AZ Groeninge
    • Kortrijk 8500 Belgium
    • UZ Leuven Gasthuisberg
    • Leuven 3000 Belgium
    • CHU UCL Mont-Godinne
    • Mont-godinne 5530 Belgium
    • Cetus Hospital Dia Oncologia
    • Belo Horizonte MG 30110-022 Brazil
    • Hospital Luxemburgo; Oncologia
    • Belo Horizonte MG 31190-131 Brazil
    • Hospital Erasto Gaertner
    • Curitiba PR 81520-060 Brazil
    • Hospital das Clinicas - UFRGS
    • Porto Alegre RS 90035-003 Brazil
    • Hospital Sao Lucas - PUCRS
    • Porto Alegre RS 90610-000 Brazil
    • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo SP 01246-000 Brazil
    • Hospital Alemao Oswaldo Cruz
    • Sao Paulo SP 01323-903 Brazil
    • Tom Baker Cancer Centre-Calgary
    • Calgary Alberta T2N 4N2 Canada
    • Cross Cancer Institute
    • Edmonton Alberta T6G 1Z2 Canada
    • Bcca - Cancer Center Southern Interior
    • Kelowna British Columbia V1Y 5L3 Canada
    • BCCA-Vancouver Cancer Centre
    • Vancouver British Columbia V5Z 4E6 Canada
    • Queen Elizabeth II Health Sciences Centre; Oncology
    • Halifax Nova Scotia B3H 2Y9 Canada
    • Hamilton Health Sciences - Juravinski Cancer Centre
    • Hamilton Ontario L8V 5C2 Canada
    • The Ottawa Hospital Cancer Centre; Oncology
    • Ottawa Ontario K1H 8L6 Canada
    • North York General Hospital; Inpatient Pharmacy
    • Toronto Ontario M2K 1E1 Canada
    • Sunnybrook Odette Cancer Centre
    • Toronto Ontario M4N 3M5 Canada
    • Princess Margaret Cancer Center
    • Toronto Ontario M5G 1Z5 Canada
    • McGill University Health Center
    • Montreal Quebec H4A 3J1 Canada
    • CHUS (Centre Hospitalier Universitaire de Sherbrooke)
    • Sherbrooke Quebec J1H 5N4 Canada
    • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
    • Quebec G1R 3S1 Canada
    • Bradford Hill Centro de Investigaciones Clinicas; Bradford Hill Centro de Investigaciones Clinicas
    • Recoleta 8420383 Chile
    • Sociedad de Investigaciones Medicas Ltda (SIM)
    • Temuco 4810469 Chile
    • ONCOCENTRO APYS; Oncología
    • Vina Del Mar 2520598 Chile
    • Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University)
    • Nanjing City 210029 China
    • Jiangsu Cancer Hospital
    • Nanjing 210009 China
    • Fudan University Shanghai Cancer Center; Medical Oncology
    • Shanghai 200032 China
    • Masarykuv onkologicky ustav
    • Brno 656 53 Czechia
    • Fakultni nemocnice Olomouc; Onkologicka klinika
    • Olomouc 779 00 Czechia
    • General University Hospital; CLINIC OF ONCOLOGY
    • Praha 2 128 08 Czechia
    • Thomayerova nemocnice
    • Praha 4 - Krc 140 59 Czechia
    • Fakultni nemocnice Kralovske Vinohrady
    • Praha 110 34 Czechia
    • Aarhus Universitetshospital; Kræftafdelingen
    • Aarhus N 8200 Denmark
    • Herlev Hospital; Onkologisk afdeling
    • Herlev 2730 Denmark
    • Odense Universitetshospital, Onkologisk Afdeling R
    • Odense C 5000 Denmark
    • CHU d'Angers
    • Angers 49033 France
    • CHU Henri Mondor; Service d'Oncologie Medicale
    • Creteil 94010 France
    • CHU Grenoble Hopital Albert Michallon; Urologie et Transplantation rénale
    • La Tronche 38700 France
    • Polyclinique de Limoges - Site Chenieux; Oncologie Medicale
    • Limoges 87039 France
    • CHU de Nantes - Hotel Dieu
    • Nantes 44093 France
    • Institut Mutualiste Montsouris; Oncologie
    • Paris 75674 France
    • CHU Pontchaillou
    • Rennes 35000 France
    • CHU de Rouen - Hôpital Charles Nicolle
    • Rouen 76031 France
    • Nouvel Hopital Civil - CHU Strasbourg; Urologie
    • Strasbourg 67091 France
    • Institut Gustave Roussy
    • Villejuif 94805 France
    • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
    • Dresden 01307 Germany
    • Kliniken Essen-Mitte; Klinik für Urologie, Kinderurologie und Urologische Onkologie
    • Essen 45136 Germany
    • Universitätsklinikum Hamburg-Eppendorf Onkologisches Zentrum Medizinische Klinik II
    • Hamburg 20246 Germany
    • Medizinische Hochschule; Zentrum Innere Medizin; Abt. Hämatologie u. Onkologie
    • Hannover 30625 Germany
    • Universitatsklinik Heidelberg; Universitätshautklinik und Nationales Centrum für Tumorerkrankungen
    • Heidelberg 69120 Germany
    • Universitätsklinikum des Saarlandes; Klinik für Urologie und Kinderurologie
    • Homburg/Saar 66424 Germany
    • Uniklinik Köln, Klinik für Urologie, Uro-Onkologie und spezielle urologische Chirurgie
    • Köln 50937 Germany
    • Klinikum rechts der Isar der TU München; Urologische Klinik und Poliklinik
    • München 81675 Germany
    • Universitätsklinikum Tübingen; Klinik für Urologie
    • Tübingen 72076 Germany
    • Universitätsklinikum Ulm; Klinik für Urologie
    • Ulm 89081 Germany
    • Cork Uni Hospital; Oncology Dept
    • Cork Ireland
    • Adelaide & Meath Hospital, Dublin, Incorporating the National Children's Hospital; Oncology Day Unit
    • Dublin 24 Ireland
    • Soroka Medical Center; Oncology Dept
    • Beer Sheva 8410101 Israel
    • Rambam Health Care Campus; Oncology
    • Haifa 3109601 Israel
    • Hadassah Ein Karem Hospital; Oncology Dept
    • Jerusalem 9112001 Israel
    • Meir Medical Center; Oncology
    • Kfar-Saba 4428164 Israel
    • Belinson Medical Center, Division of Oncology
    • Petach Tikva 4941492 Israel
    • Chaim Sheba medical center, Oncology division
    • Ramat Gan 5262000 Israel
    • Sourasky Medical Center; Oncology Department
    • Tel-Aviv 6423900 Israel
    • Az. Osp. Cardarelli; Divisione Di Oncologia
    • Napoli Campania 80131 Italy
    • Azienda Ospedaliero-Universitaria S.Orsola-Malpighi; Unità Operativa Oncologia Medica
    • Bologna Emilia-Romagna 40138 Italy
    • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Meldola Emilia-Romagna 47014 Italy
    • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Modena Emilia-Romagna 41100 Italy
    • Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2
    • Milano Lombardia 20133 Italy
    • Fondazione IRCCS Policlinico San Matteo, Oncologia
    • Pavia Lombardia 27100 Italy
    • Istituti Clinici Scientifici Maugeri SpA-SB
    • Pavia Lombardia 27100 Italy
    • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
    • Arezzo Toscana 52100 Italy
    • IRCCS Istituto Oncologico Veneto (IOV); Oncologia Medica Prima
    • Padova Veneto 35128 Italy
    • Nagoya University Hospital
    • Aichi 466-8560 Japan
    • Hirosaki University Hospital
    • Aomori 036-8563 Japan
    • Kyushu University Hospital
    • Fukuoka 812-8582 Japan
    • Hiroshima City Hiroshima Citizens Hospital
    • Hiroshima 730-8518 Japan
    • Kobe University Hospital
    • Hyogo 650-0017 Japan
    • University of Tsukuba Hospital
    • Ibaraki 305-8576 Japan
    • Kagoshima City Hospital
    • Kagoshima 890-8760 Japan
    • Mie University Hospital
    • Mie 514-8507 Japan
    • Niigata University Medical & Dental Hospital
    • Niigata 951-8520 Japan
    • Okayama University Hospital
    • Okayama 700-8558 Japan
    • Kindai University Hospital
    • Osaka 589-8511 Japan
    • Jichi Medical University Hospital
    • Tochigi 329-0498 Japan
    • Tokushima University Hospital
    • Tokushima 770-8503 Japan
    • Toranomon Hospital
    • Tokyo 105-8470 Japan
    • Tokyo Medical & Dental University Hospital
    • Tokyo 113-8519 Japan
    • Nippon Medical School Hospital
    • Tokyo 113-8603 Japan
    • Tokyo Women's Medical University Medical Center East
    • Tokyo 116-8567 Japan
    • The Cancer Institute Hospital of JFCR
    • Tokyo 135-8550 Japan
    • Keio University Hospital
    • Tokyo 160-8582 Japan
    • National Cancer Center; Neurology
    • Gyeonggi-do 10408 Korea, Republic of
    • Asan Medical Center - Oncology
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center - Neurology
    • Seoul 6351 Korea, Republic of
    • VU Medisch Centrum; VU University Medical Center
    • Amsterdam 1007 MB Netherlands
    • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
    • Amsterdam 1066 CX Netherlands
    • Academ Ziekenhuis Groningen; Medical Oncology
    • Groningen 9713 GZ Netherlands
    • UMC Radboud Nijmegen
    • Nijmegen 6500 HB Netherlands
    • Sint Franciscus Gasthuis; Inwendige Geneeskunde
    • Rotterdam 3045 PM Netherlands
    • St. Antonius locatie Leidsche Rijn
    • Utrecht 3543 AZ Netherlands
    • Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Kliniki Onkologii
    • Krakow 31-531 Poland
    • Klinika Onkologii Klinicznej CO-I Kraków
    • Krakow Poland
    • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
    • Lublin 20-090 Poland
    • Szpital Kliniczny Przemienienia Pańskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego
    • Poznan 60-570 Poland
    • Centralny Szpital Kliniczny MSWiA; Klinika Onkologii i Hematologii
    • Warsaw 02-507 Poland
    • Saint Elizabeth's Hospital
    • Warsaw 02-616 Poland
    • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu
    • Wroclaw 50-556 Poland
    • Moscow City Clinical Hospital #57; Oncourology
    • Moskva Moskovskaja Oblast 105077 Russian Federation
    • Altai Region Oncology Dispensory; Oncology
    • Barnaul 656049 Russian Federation
    • Sverdlovsk Regional Clinical Hospital 1
    • Ekaterinburg 620102 Russian Federation
    • Ivanovo Regional Oncology Dispensary
    • Ivanovo 153040 Russian Federation
    • Blokhin Cancer Research Center; Urological Dept
    • Moscow 115478 Russian Federation
    • First Moscow State Medical University n.a. I.M. Sechenov
    • Moscow 119991 Russian Federation
    • P.A. Herzen Oncological Inst. ; Oncology
    • Moscow 125284 Russian Federation
    • City Clinical Oncology Hospital
    • Moscow 143423 Russian Federation
    • Privolzhsk Regional Medical Center
    • Nizhny Novgorod 603001 Russian Federation
    • City Clinical Oncology Dispensary
    • Saint-Petersburg 197022 Russian Federation
    • Multidisciplinary clinic Reaviz
    • Samara 443011 Russian Federation
    • Scientific Research Oncology Institute named after N.N. Petrov; Oncology
    • St. Petersburg 197758 Russian Federation
    • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
    • Belgrade 11000 Serbia
    • Clinic for Urology; Military Medical Academy
    • Belgrade 11000 Serbia
    • Institute for Oncology and Radiology of Serbia; Medical Oncology
    • Belgrade 11000 Serbia
    • Oncology Institute of Vojvodina
    • Sremska Kamenica 21204 Serbia
    • Hospital Univ. Central de Asturias; Servicio de Oncologia
    • Oviedo Asturias 33011 Spain
    • Hospital Universitario Reina Sofia; Servicio de Oncologia
    • Córdoba Cordoba 14004 Spain
    • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia
    • Santiago de Compostela LA Coruña 15706 Spain
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
    • Barcelona 08035 Spain
    • Hospital Clínic i Provincial; Servicio de Oncología
    • Barcelona 08036 Spain
    • Institut Catala d Oncologia Hospital Duran i Reynals
    • Barcelona 08908 Spain
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
    • Madrid 28007 Spain
    • Hospital Ramon y Cajal; Servicio de Oncologia
    • Madrid 28034 Spain
    • Hospital Universitario Clínico San Carlos; Servicio de Oncologia
    • Madrid 28040 Spain
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
    • Madrid 28041 Spain
    • China Medical University Hospital; Urology
    • Taichung 40447 Taiwan
    • Taichung Veterans General Hospital; Division of Urology
    • Taichung 407 Taiwan
    • National Taiwan University Hospital, Department of Urology
    • Taipei 10048 Taiwan
    • TAIPEI VETERANS GENERAL HOSPITAL, Urology
    • Taipei 11217 Taiwan
    • Chang Gung Medical Foundation-Linkou, Urinary Oncology
    • Taoyuan 333 Taiwan
    • Division of Urological surgery; Department of surgery, Chulalongkorn University
    • Bangkok 10330 Thailand
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
    • Bangkok 10400 Thailand
    • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
    • Chiangmai 50200 Thailand
    • Adana City Hospital, Medical Oncology
    • Adana 01060 Turkey
    • Baskent University Adana Dr. Turgut Noyan Practice and Research Hospital; Medical Oncology
    • Adana 01250 Turkey
    • Gazi University Medical Faculty; Department of İnternal Medicine
    • Ankara 06500 Turkey
    • Ankara Uni School of Medicine; Medical Oncology
    • Ankara 06590 Turkey
    • Trakya University Medical Faculty
    • Edirne 22030 Turkey
    • Hacettepe Uni Medical Faculty Hospital; Oncology Dept
    • Sıhhiye, Ankara 06100 Turkey
    • Regional Clinical Center of Urology and Nephrology n.a. V.I. Shapoval Department of Urology #4
    • Kharkiv Kharkiv Governorate 61037 Ukraine
    • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
    • Dnipropetrovsk 49102 Ukraine
    • GU "Institution of urology of Academy Medical science of Ukraine"
    • Kiev 04053 Ukraine
    • National Institute of Cancer
    • Kyiv 03022 Ukraine
    • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
    • Lviv 79031 Ukraine
    • Regional Municipal Institution Sumy Regional Clinical Oncology Dispensary
    • Sumy 40005 Ukraine
    • Zaporizhzhia Regional Clinic
    • Zaporizhzhia 69600 Ukraine
    • Leicester Royal Infirmary
    • Leicester LE1 5WW United Kingdom
    • Royal Free Hospital
    • London NW3 2QS United Kingdom
    • Christie Hospital
    • Manchester M20 3BG United Kingdom
    • Freeman Hospital
    • Newcastle upon Tyne NE7 7DN United Kingdom
    • Weston Park Hospital
    • Sheffield S10 2SJ United Kingdom
    • Singleton Hospital; Pharmacy Department
    • Swansea SA2 8QA United Kingdom

    View trial on ClinicalTrials.gov


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    Published August 3, 2018
  • A Phase III, Open-Label, Randomized Study Of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma

    {{header-clinical-trials-navigation}}

    A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) in Combination With Bevacizumab Versus Sunitinib in Patients With Untreated Advanced Renal Cell Carcinoma


    Condition: Renal Cell Carcinoma

    Intervention:

    • Drug: Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody
    • Drug: Bevacizumab
    • Drug: Sunitinib

    Purpose: This multi-center, randomized, open-label study will evaluate the efficacy and safety of atezolizumab (MPDL3280A) plus bevacizumab versus sunitinib in participants with inoperable, locally advanced, or metastatic renal cell carcinoma (RCC) who have not received prior systemic active or experimental therapy, either in the adjuvant or metastatic setting.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT02420821

    Sponsor: Hoffmann-La Roche

    Primary Outcome Measures:

    • Measure: Progression-Free Survival (PFS) as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in Participants with Detectable Programmed Death-Ligand 1 (PD-L1)
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: Overall Survival (OS) in all Randomized Participants
    • Time Frame: Baseline until death due to any cause (up to 63 months)
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: OS in Participants with Detectable PD-L1
    • Time Frame: Baseline until death due to any cause (up to 63 months)
    • Safety Issue:
    • Measure: PFS as Determined by an Independent Review Committee (IRC) According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: Percentage of Participants With an Objective Response of Complete Response (CR) or Partial Response (PR) as Determined by the Investigator According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: Duration of Response (DOR) as Determined by the Investigator According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: Percentage of Participants With an Objective Response of CR or PR as Determined by an IRC According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: DOR as Determined by an IRC According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: PFS as Determined by the Investigator According to Modified RECIST
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: Percentage of Participants With an Objective Response of CR or PR as Determined by the Investigator According to Modified RECIST
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: DOR as Determined by the Investigator According to Modified RECIST
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: PFS in All Randomized Participants as Determined by the Investigator According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: PFS in Participants With Sarcomatoid Histology as Determined by the Investigator According to RECIST v1.1
    • Time Frame: Baseline until confirmed disease progression or death, whichever occurs first (assessed at baseline, Week 12, then every 6 weeks through Week 78 and then every 12 weeks thereafter until disease progression [up to 63 months])
    • Safety Issue:
    • Measure: OS in Participants With Sarcomatoid Histology
    • Time Frame: Baseline until death due to any cause (up to 63 months)
    • Safety Issue:
    • Measure: Change From Baseline in Symptom Interference as Determined by M.D. Anderson Symptom Inventory (MDASI) Part II
    • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Change From Baseline in Symptom Severity as Determined by MDASI
    • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Change From Baseline in Symptom Severity as Determined by Brief Fatigue Inventory (BFI)
    • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle and weekly during the first 12 weeks, up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Change From Baseline in Treatment Side Effects Subscale From Functional Assessment of Cancer Therapy Kidney Symptom Index (FKSI-19)
    • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Change From Baseline in Health-Related Quality of Life as Determined by European Quality of Life 5-Dimension (EQ-5D) Scores
    • Time Frame: Baseline up to 63 months (assessed on Day 1 and Day 22 of each cycle up to treatment discontinuation [up to 63 months], at 6, 12, 24, and 36 weeks after treatment discontinuation [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Percentage of Participants With Adverse Events (AEs) or Serious AEs (SAEs)
    • Time Frame: Baseline up to 63 months
    • Safety Issue:
    • Measure: Percentage of Participants With Anti--Therapeutic Antibodies (ATAs) Against Atezolizumab
    • Time Frame: Baseline up to 63 months (assessed at pre-dose [Hour 0] on Day 1 of Cycles 1, 2, 4, 8, and every 8 cycles thereafter up to treatment discontinuation [up to 63 months] , and 120 days after last dose [up to 63 months]) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Maximum Serum Concentration (Cmax) for Atezolizumab
    • Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-60 minutes) on Cycle 1, Day 1 (Cycle = 42 days)
    • Safety Issue:
    • Measure: Minimum Serum Concentration (Cmin) for Atezolizumab
    • Time Frame: Pre-dose (Hour 0) on Days 1 and 22 of Cycles 1, 2, and 4; pre-dose (Hour 0) on Day 1 of Cycle 8 and every 8 cycles thereafter up to treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days)
    • Safety Issue:
    • Measure: Cmax for Bevacizumab
    • Time Frame: 30 minutes after the end of atezolizumab infusion (infusion duration: 30-90 minutes) on Cycle 1, Day 1 and Cycle 3, Day 1 (Cycle = 42 days)
    • Safety Issue:
    • Measure: Cmin for Bevacizumab
    • Time Frame: Pre-dose (Hour 0) on Cycle 1, Day 1 and Cycle 3, Day 1, at the treatment discontinuation (up to 63 months), and 120 days after last dose (up to 63 months) (Cycle = 42 days)
    • Safety Issue:

    Estimated Enrollment: 915

    Study Start Date: May 31, 2015

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Definitive diagnosis of unresectable locally advanced or metastatic RCC with clear-cell histology and/or a component of sarcomatoid carcinoma, with no prior treatment in the metastatic setting
    • Evaluable Memorial Sloan Kettering Cancer Center risk score
    • Measurable disease, as defined by RECIST v1.1
    • Karnofsky performance status greater than or equal to 70%
    • Adequate hematologic and end-organ function prior to randomization Exclusion Criteria: Disease-Specific Exclusions:
    • Radiotherapy for RCC within 14 days prior to treatment
    • Active central nervous system disease
    • Uncontrolled pleural effusion, pericardial effusion, or ascites
    • Uncontrolled hypercalcemia
    • Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death General Medical Exclusions:
    • Life expectancy less than 12 weeks
    • Participation in another experimental drug study within 4 weeks prior to treatment
    • Pregnant or lactating women
    • Known hypersensitivity to any component of atezolizumab or other study medication
    • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
    • Positive human immunodeficiency virus test
    • Active or chronic hepatitis B or C
    • Severe infections within 4 weeks prior to treatment
    • Exposure to oral or IV antibiotics within 2 weeks prior to treatment
    • Live attenuated vaccines within 4 weeks prior to treatment, 28 days prior to randomization, during treatment, or within 5 months following last dose of atezolizumab
    • Significant cardiovascular disease
    • Prior allogeneic stem cell or solid organ transplantation

    Exclusion Criteria:

    • Disease-Specific Exclusions:
    • Radiotherapy for RCC within 14 days prior to treatment
    • Active central nervous system disease
    • Uncontrolled pleural effusion, pericardial effusion, or ascites
    • Uncontrolled hypercalcemia
    • Any other malignancies within 5 years except for low-risk prostate cancer or those with negligible risk of metastasis or death General Medical Exclusions:
    • Life expectancy less than 12 weeks
    • Participation in another experimental drug study within 4 weeks prior to treatment
    • Pregnant or lactating women
    • Known hypersensitivity to any component of atezolizumab or other study medication
    • History of autoimmune disease except controlled, treated hypothyroidism or type I diabetes mellitus
    • History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis
    • Positive human immunodeficiency virus test
    • Active or chronic hepatitis B or C
    • Severe infections within 4 weeks prior to treatment
    • Exposure to oral or IV antibiotics within 2 weeks prior to treatment
    • Live attenuated vaccines within 4 weeks prior to treatment, 28 days prior to randomization, during treatment, or within 5 months following last dose of atezolizumab
    • Significant cardiovascular disease
    • Prior allogeneic stem cell or solid organ transplantation Exclusion Criteria Related to Medications:
    • Prior treatment with cluster of differentiation 137 agonists, anti-cytotoxic T-lymphocyte associated protein-4, anti-programmed death (PD)-1, or anti-PD-L1 therapeutic antibody or pathway-targeting agents
    • Treatment with immunostimulatory agents for non-malignant conditions within 6 weeks or immunosuppressive agents within 2 weeks prior to treatment Bevacizumab- and Sunitinib-Specific Exclusions:
    • History of hypertensive crisis or hypertensive encephalopathy
    • Baseline electrocardiogram showing corrected QT interval greater than 460 milliseconds

    Contact:

    • Reference Study ID Number: WO29637 www.roche.com/about_roche/roche_worldwide.htm
    • 888-662-6728 (U.S. and Canada)

    Locations:

    • University of Arizona Cancer Center
    • Tucson Arizona 85719 United States
    • Univ of Calif, Los Angeles; Hematology/Oncology
    • Los Angeles California 90095 United States
    • University of California at Irvine Medical Center; Department of Oncology
    • Orange California 92868 United States
    • University of California
    • San Francisco California 94158 United States
    • University of Colorado; Anschutz Cancer Pavilion
    • Aurora Colorado 80045 United States
    • Rocky Mountain Cancer Center; Medical Oncology
    • Denver Colorado 80218 United States
    • Yale School of Medicine
    • New Haven Connecticut 06510 United States
    • Washington Cancer Institute at MedStar Washington Hospital Center.
    • Washington District of Columbia 20010 United States
    • Georgetown U; Lombardi Comp Can
    • Washington District of Columbia 20016-1468 United States
    • Lynn Cancer Institute/Boca Raton Regional Hospital
    • Boca Raton Florida 33486 United States
    • Florida Cancer Specialists - Port Charlotte
    • Port Charlotte Florida 33980 United States
    • Florida Cancer Specialist, North Region
    • Saint Petersburg Florida 33705 United States
    • Florida Cancer Specialists
    • West Palm Beach Florida 33401 United States
    • Piedmont Cancer Institute, PC
    • Atlanta Georgia 30318 United States
    • Central Georgia Cancer Care PC
    • Macon Georgia 31201 United States
    • Northwest Georgia Oncology Centers PC - Marietta
    • Marietta Georgia 30060 United States
    • University of Hawaii Cancer Center
    • Honolulu Hawaii 96813 United States
    • The University of Chicago
    • Chicago Illinois 60637 United States
    • Norton Cancer Institute
    • Louisville Kentucky 40241 United States
    • Johns Hopkins Uni; Oncology Center
    • Baltimore Maryland 21231 United States
    • Massachusetts General Hospital
    • Boston Massachusetts 02114 United States
    • Dana Farber Cancer Inst.
    • Boston Massachusetts 02115 United States
    • Beth Israel Deaconess Medical Center
    • Boston Massachusetts 02215 United States
    • Comprehensive Cancer Centers of Nevada - Eastern Avenue
    • Las Vegas Nevada 89169 United States
    • Hackensack University Medical Center
    • Hackensack New Jersey 07601 United States
    • Hematology Oncology Associates; Carol G. Simon Ctr
    • Morristown New Jersey 07960 United States
    • New York Oncology Hematology,P.C.-Albany
    • Albany New York 12208 United States
    • Memorial Sloan-Kettering Cancer Center
    • New York New York United States
    • Oncology Hematology Care Inc
    • Cincinnati Ohio 45242 United States
    • Cleveland Clinic Foundation; Taussig Cancer Center
    • Cleveland Ohio 44195 United States
    • Compass Oncology, The Northwest Cancer Specialists - Compass Oncology Tualatin
    • Tualatin Oregon 97062 United States
    • Allegheny Cancer Center
    • Pittsburgh Pennsylvania 15212 United States
    • SCRI Tennessee Oncology Chattanooga
    • Chattanooga Tennessee 37404 United States
    • Sarah Cannon Cancer Center and Research Institute
    • Nashville Tennessee 37203 United States
    • Vanderbilt Univ Medical Ctr
    • Nashville Tennessee 37232 United States
    • Texas Oncology-Baylor Sammons Cancer Center
    • Dallas Texas 75246 United States
    • The Center for Cancer and Blood Disorders - Fort Worth
    • Fort Worth Texas 76104 United States
    • University of Virginia
    • Charlottesville Virginia 22906 United States
    • Oncology and Hematology Associates of SW Virginia-Raonoke
    • Roanoke Virginia 24014 United States
    • Seattle Cancer Care Alliance
    • Seattle Washington 98109 United States
    • Lifehouse
    • Camperdown New South Wales 2050 Australia
    • Macquarie University Hospital
    • Sydney New South Wales 2109 Australia
    • Calvary Mater Newcastle; Medical Oncology
    • Waratah New South Wales 2298 Australia
    • Icon Cancer Foundation
    • South Brisbane Queensland 4101 Australia
    • Ashford Cancer Center Research
    • Kurralta Park South Australia 5037 Australia
    • Austin Hospital; Medical Oncology
    • Heidelberg Victoria 3084 Australia
    • St John of God Hospital
    • Murdoch Western Australia WA6150 Australia
    • University Clinical Centre of the Republic of Srpska
    • Banja Luka 78000 Bosnia and Herzegovina
    • Clinic of Oncology, University Clinical Center Sarajevo
    • Sarajevo 71000 Bosnia and Herzegovina
    • Hospital de Caridade de Ijui; Oncologia
    • Ijui RS 98700-000 Brazil
    • Santa Casa de Misericordia de Porto Alegre
    • Porto Alegre RS 90020-090 Brazil
    • Hospital Sao Lucas - PUCRS
    • Porto Alegre RS 90610-000 Brazil
    • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo SP 01246-000 Brazil
    • Queen Elizabeth II Health Sciences Centre; Oncology
    • Halifax Nova Scotia B3H 2Y9 Canada
    • Royal Victoria Hospital
    • Barrie Ontario L4M 6M2 Canada
    • Hamilton Health Sciences - Juravinski Cancer Centre
    • Hamilton Ontario L8V 5C2 Canada
    • London Regional Cancer Centre
    • London Ontario N6A 4L6 Canada
    • Lakeridge Health Oshawa; Oncology
    • Oshawa Ontario L1G 2B9 Canada
    • The Ottawa Hospital Cancer Centre; Oncology
    • Ottawa Ontario K1H 8L6 Canada
    • Sunnybrook Odette Cancer Centre
    • Toronto Ontario M4N 3M5 Canada
    • University Health Network; Princess Margaret Hospital; Medical Oncology Dept
    • Toronto Ontario M5G 2M9 Canada
    • McGill University; Sir Mortimer B Davis Jewish General Hospital; Oncology
    • Montreal Quebec H3T 1E2 Canada
    • Centre Hospitalier universitaire de Québec/ Hotel Dieu de Québec
    • Quebec G1R 3S1 Canada
    • Masarykuv onkologicky ustav
    • Brno 656 53 Czechia
    • Fakultni nemocnice Olomouc; Onkologicka klinika
    • Olomouc 779 00 Czechia
    • Fakultni Poliklinika Vseobecne Fakultni Niemocnice; Onkologicka Klinika
    • Praha 2 128 08 Czechia
    • Thomayerova nemocnice
    • Praha 4 - Krc 140 59 Czechia
    • Aarhus Universitetshospital; Kræftafdelingen
    • Aarhus N 8200 Denmark
    • Herlev Hospital; Onkologisk afdeling
    • Herlev 2730 Denmark
    • Odense Universitetshospital, Onkologisk Afdeling R
    • Odense 5000 Denmark
    • ICO Paul Papin; Oncologie Medicale.
    • Angers 49055 France
    • Hopital Saint Andre; Oncologie 2
    • Bordeaux 33075 France
    • Centre Francois Baclesse; Urologie Gynecologie
    • Caen 14076 France
    • Centre Oscar Lambret
    • Lille 59020 France
    • Centre Léon Bérard
    • Lyon 69373 France
    • Institut Paoli Calmettes; Oncologie Medicale
    • Marseille 13273 France
    • Centre D'Oncologie de Gentilly; Oncology
    • Nancy 54100 France
    • APHP - Hospital Saint Louis
    • Paris 75475 France
    • Hopital Europeen Georges Pompidou; Service D'Oncologie Medicale
    • Paris 75908 France
    • ICO - Site René Gauducheau
    • Saint Herblain 44805 France
    • Institut Claudius Regaud; Departement Oncologie Medicale
    • Toulouse 31059 France
    • Institut Gustave Roussy; Departement Oncologie Medicale
    • Villejuif 94805 France
    • Campus Charitè Mitte Charité Centrum 10. Klinik f.Urologie
    • Berlin 10117 Germany
    • Universitätsklinikum "Carl Gustav Carus"; Klinik und Poliklinik für Urologie
    • Dresden 01307 Germany
    • Universitätsklinikum Essen; Innere Klinik und Poliklinik für Tumorforschung
    • Essen 45122 Germany
    • Nationales Centrum für Tumorerkrankungen Heidelberg (NCT); Thoraxklinik Heidelberg
    • Heidelberg 69120 Germany
    • Klinikum d.Universität München Campus Großhadern
    • München 81377 Germany
    • Universitätsklinikum Tübingen; Klinik für Urologie
    • Tübingen 72076 Germany
    • Az. Osp. Cardarelli; Divisione Di Oncologia
    • Napoli Campania 80131 Italy
    • IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica
    • Meldola Emilia-Romagna 47014 Italy
    • A.O. Universitaria Policlinico Di Modena; Oncologia
    • Modena Emilia-Romagna 41100 Italy
    • Azienda Ospedaliera San Camillo Forlanini; Oncologia Medica
    • Roma Lazio 00152 Italy
    • Irccs Ospedale San Raffaele;Oncologia Medica
    • Milano Lombardia 20132 Italy
    • Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia
    • Milano Lombardia 20162 Italy
    • Fondazione IRCCS Policlinico San Matteo, Oncologia
    • Pavia Lombardia 27100 Italy
    • Azienda USL8 Arezzo-Presidio Ospedaliero 1 San Donato;U.O.C. Oncologia
    • Arezzo Toscana 52100 Italy
    • Nagoya University Hospital; Urology
    • Aichi 466-8560 Japan
    • Chiba Cancer Center
    • Chiba 260-8717 Japan
    • Kyushu University Hospital
    • Fukuoka 812-8582 Japan
    • Gunma University Hospital
    • Gunma 371-8511 Japan
    • Hokkaido University Hospital
    • Hokkaido 060-8648 Japan
    • University of Tsukuba Hospital; Urology
    • Ibaraki 305-8576 Japan
    • Iwate Medical University Hospital
    • Iwate 020-8505 Japan
    • Yokohama City University Hospital
    • Kanagawa 236-0004 Japan
    • Kitasato University Hospital
    • Kanagawa 252-0375 Japan
    • Kumamoto University Hospital
    • Kumamoto 860-8556 Japan
    • Niigata University Medical & Dental Hospital
    • Niigata 951-8520 Japan
    • Okayama University Hospital
    • Okayama 700-8558 Japan
    • Osaka International Cancer Institute; Urology
    • Osaka 541-8567 Japan
    • Osaka City University Hospital
    • Osaka 545-8586 Japan
    • Osaka University Hospital
    • Osaka 565-0871 Japan
    • Kindai University Hospital
    • Osaka 589-8511 Japan
    • Saitama Medical University International Medical Center
    • Saitama 350-1298 Japan
    • Tokushima University Hospital
    • Tokushima 770-8503 Japan
    • Toranomon Hospital
    • Tokyo 105-8470 Japan
    • Tokyo Medical & Dental University Hospital
    • Tokyo 113-8519 Japan
    • Nippon Medical School Hospital
    • Tokyo 113-8603 Japan
    • The Cancer Institute Hospital, JFCR; Urology
    • Tokyo 135-8550 Japan
    • Keio University Hospital
    • Tokyo 160-8582 Japan
    • Tokyo Women's Medical University
    • Tokyo 162-0054 Japan
    • Chungnam National University Hospital
    • Daejeon 35015 Korea, Republic of
    • National Cancer Center
    • Gyeonggi-do 10408 Korea, Republic of
    • Seoul National University Bundang Hospital
    • Gyeonggi-do 13620 Korea, Republic of
    • Seoul National University Hospital
    • Seoul 03080 Korea, Republic of
    • Severance Hospital, Yonsei University Health System
    • Seoul 03722 Korea, Republic of
    • Asan Medical Center
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center
    • Seoul 06351 Korea, Republic of
    • Hospital General de Mexico; Jefatura de Investigacion
    • Mexico City 06726 Mexico
    • Accelerium S. de R.L. de C.V.
    • Monterrey 64000 Mexico
    • Cancerología
    • Queretaro 76090 Mexico
    • Centro Oncologico Estatal ISSEMYM
    • Toluca 50180 Mexico
    • Hospital Regional de Alta Especialidad de Veracruz; Oncology
    • Veracruz 91700 Mexico
    • Consultorio Médico
    • Zapopan, Jalisco 45040 Mexico
    • Centrum Onkologii;Im. Franciszka Lukaszczyka;Onkologii
    • Bydgoszcz 85-796 Poland
    • Wojewódzki Szpital Specjalistyczny im. M. Kopernika; Oddział Chemioterapii
    • Lodz 93-513 Poland
    • Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli
    • Lublin 20-090 Poland
    • Szpital Kliniczny; Przemienienia Panskiego;Uniwersytetu Medyczny im.; Karola Marcinkowskiego w Pozna
    • Poznan 60-569 Poland
    • Saint Elizabeth's Hospital
    • Warsaw 02-616 Poland
    • Centrum Med. Ostrobramska NZOZ Magodent
    • Warszawa 04-125 Poland
    • Uniwersytecki Szpital Kliniczny im. Jana Miklulicza-Radeckiego we Wrocławiu; Departament Of Urology
    • Wroclaw 50-556 Poland
    • ALTAI REGIONAL ONCOLOGICAL CENTER; "Nadezhda" Clinic
    • Barnaul Altaj 656049 Russian Federation
    • GBUZ Nizhegorodskay Region: Clinical Diagnostic Center
    • Nizhni Novgorod Niznij Novgorod 603001 Russian Federation
    • P.A. Herzen Oncological Inst. ; Oncology
    • Moscow 125284 Russian Federation
    • Moscow city oncology hospital #62 of Moscow Healthcare Department
    • Moscow 143423 Russian Federation
    • Clinic for Urology, Clinical Center of Serbia; Clinic for Urology
    • Belgrade 11000 Serbia
    • Clinic for Urology; Clinical Hospital Center "Dragisa Misovic-Dedinje"
    • Belgrade 11000 Serbia
    • Institute For Oncology Sremska Kamenica; Internal Medicine Department
    • Sremska Kamenica 21204 Serbia
    • National University Hospital
    • Singapore 119074 Singapore
    • National Cancer Centre; Medical Oncology
    • Singapore 169610 Singapore
    • Oncocare Cancer Centre
    • Singapore 258499 Singapore
    • Corporacio Sanitaria Parc Tauli; Servicio de Oncologia
    • Sabadell Barcelona 08208 Spain
    • Hospital Universitario Reina Sofia; Servicio de Oncologia
    • Córdoba Cordoba 14004 Spain
    • Hospital Univ Vall d'Hebron; Servicio de Oncologia
    • Barcelona 08035 Spain
    • Hospital Clínic i Provincial; Servicio de Oncología
    • Barcelona 08036 Spain
    • Hospital de la Santa Creu i Sant Pau; Servicio de Oncologia
    • Barcelona 08041 Spain
    • Hospital Duran i Reynals; Oncologia
    • Barcelona 08907 Spain
    • Hospital General Universitario Gregorio Marañon; Servicio de Oncologia
    • Madrid 28007 Spain
    • Hospital Ramon y Cajal; Servicio de Oncologia
    • Madrid 28034 Spain
    • Hospital Universitario 12 de Octubre; Servicio de Oncologia
    • Madrid 28041 Spain
    • Hospital Universitario Virgen del Rocio; Servicio de Oncologia
    • Sevilla 41013 Spain
    • Taichung Veterans General Hospital; Division of Urology
    • Taichung 407 Taiwan
    • National Taiwan Uni Hospital; Dept of Oncology
    • Taipei 100 Taiwan
    • Chang Gung Medical Foundation-Linkou, Urinary Oncology
    • Taoyuan 333 Taiwan
    • Chulalongkorn Hospital; Medical Oncology
    • Bangkok 10330 Thailand
    • Ramathibodi Hospital; Dept of Med.-Div. of Med. Onc
    • Bangkok 10400 Thailand
    • Faculty of Med. Siriraj Hosp.; Med.-Div. of Med. Oncology
    • Bangkok 10700 Thailand
    • Maharaj Nakorn Chiangmai Hospital; Department of Surgery/ Urology unit
    • Chiangmai 50200 Thailand
    • Prince of Songkla Uni ; Unit of Medical Oncology
    • Songkhla 90110 Thailand
    • Hacettepe University Medical Faculty
    • Ankara 6100 Turkey
    • Uludag Uni Hospital; Oncology
    • Bursa 16059 Turkey
    • Trakya University Medical Faculty Research And Practice Hospital Medical Oncology Department
    • Edirne 22770 Turkey
    • Istanbul Uni Cerrahpasa Medical Faculty Hospital; Medical Oncology
    • Istanbul 34300 Turkey
    • CI Dnipropetrovsk CMCH #4 MA of MOHU Ch of Oncology and MR
    • Dnipropetrovsk 49102 Ukraine
    • GU "Institution of urology of Academy Medical science of Ukraine"
    • Kiev 04053 Ukraine
    • Lviv State Oncology Regional Treatment and Diagnostic Centre; Department of hemotherapy
    • Lviv 79031 Ukraine
    • Zaporizhzhia Regional Clinic
    • Zaporizhzhia 69600 Ukraine
    • Clatterbridge Cancer Centre
    • Bebington CH63 4JY United Kingdom
    • Queen Elizabeth Hospital
    • Birmingham B15 2TH United Kingdom
    • Royal Blackburn Hospital
    • Blackburn BB2 3HH United Kingdom
    • Addenbrookes Nhs Trust; Oncology Clinical Trials Unit
    • Cambridge CB2 0QQ United Kingdom
    • Barts Health NHS Trust - St Bartholomew's Hospital
    • London EC1A 7BE United Kingdom
    • Royal Free Hospital; Dept of Oncology
    • London NW3 2QG United Kingdom
    • Royal Marsden Hospital; Dept of Med-Onc
    • London SW3 6JJ United Kingdom
    • Christie Hospital Nhs Trust; Medical Oncology
    • Manchester M2O 4BX United Kingdom
    • Churchill Hospital; Oxford Cancer and Haematology Centre
    • Oxford OX3 7LJ United Kingdom
    • Southampton General Hospital; Medical Oncology
    • Southampton SO16 6YD United Kingdom
    • Royal Marsden Hospital; Dept of Medical Oncology
    • Sutton SM2 5PT United Kingdom
    • Singleton Hospital; Pharmacy Department
    • Swansea SA2 8QA United Kingdom

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published June 9, 2017
  • A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)

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    A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Pembrolizumab (MK-3475) as Monotherapy in the Adjuvant Treatment of Renal Cell Carcinoma Post Nephrectomy (KEYNOTE-564)


    Condition: Renal Cell Carcinoma

    Intervention:

    • Biological: Pembrolizumab
    • Drug: Placebo (saline solution)

    Purpose: The purpose of this study is to evaluate the safety and efficacy of pembrolizumab (MK-3475) in the adjuvant treatment of adult participants who have undergone nephrectomy and have intermediate-high risk, high risk, or M1 no evidence of disease (M1 NED) renal cell carcinoma (RCC) with clear cell component. The primary study hypothesis is that pembrolizumab is superior to placebo with respect to Disease-free Survival (DFS) as assessed by the Investigator in male and female participants with intermediate-high risk, high risk and M1 NED RCC.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03142334

    Sponsor: Merck Sharp & Dohme Corp.

    Primary Outcome Measures:

    • Measure: Disease-free Survival (DFS) as Assessed by the Investigator
    • Time Frame: Up to approximately 72 months
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Overall Survival (OS)
    • Time Frame: Up to approximately 72 months
    • Safety Issue:
    • Measure: Adverse Events (AEs)
    • Time Frame: Nonserious AEs: Up to 30 days after last dose of study treatment (Up to approximately 13 months); Serious AEs: Up to 90 days after last dose of study treatment (Up to approximately 15 months)
    • Safety Issue:
    • Measure: Study Treatment Discontinuations Due to an AE
    • Time Frame: Up to approximately 12 months
    • Safety Issue:
    • Measure: First Local Disease Recurrence-specific Survival (DRSS1) as Assessed by the Investigator
    • Time Frame: Up to approximately 72 months
    • Safety Issue:
    • Measure: First Local Recurrence with Visceral Lesion or Distant Metastasis with Visceral Lesion or Secondary Systemic Malignancy with Visceral Lesion (DRSS2) as Assessed by the Investigator
    • Time Frame: Up to approximately 72 months
    • Safety Issue:
    • Measure: DFS According to Participant Programmed Cell Death-Ligand 1 (PD-L1) Expression Status (Positive, Negative) as Assessed by the Investigator
    • Time Frame: Up to approximately 72 months
    • Safety Issue:
    • Measure: OS According to Participant PD-L1 Expression Status (Positive, Negative)
    • Time Frame: Up to approximately 72 months
    • Safety Issue:
    • Measure: Plasma Clearance (CL) of Pembrolizumab
    • Time Frame: Cycles 1 and 2: Pre-dose and 0.5 hours (h) after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
    • Safety Issue:
    • Measure: Volume of Distribution (VD) of Pembrolizumab
    • Time Frame: Cycles 1 and 2: Pre-dose and 0.5 h after end of infusion; Cycles 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
    • Safety Issue:
    • Measure: Development of Anti-pembrolizumab Antibodies
    • Time Frame: Cycles 1, 3, 5, 13 and 17: Pre-dose; and 30 days after study treatment discontinuation. Each cycle is 3 weeks long. (Up to approximately 13 months)
    • Safety Issue:
    • Measure: European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) Total Score
    • Time Frame: Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)
    • Safety Issue:
    • Measure: Functional Assessment of Cancer Therapy Kidney Symptom Index-Disease Related Symptoms (FKSI-DRS) Index Score
    • Time Frame: Baseline and Cycles 1, 5, 9, 13, and 17, treatment discontinuation, 30 day follow up, and annually during post-treatment follow up. Each cycle is 3 weeks long. (Up to approximately 72 months)
    • Safety Issue:

    Estimated Enrollment: 950

    Study Start Date: June 9, 2017

    Phase: Phase 3

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • Has histologically confirmed diagnosis of RCC with clear cell component with or without sarcomatoid features.
    • Female participants of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 120 days after the last dose of study treatment.
    • Male participants of childbearing potential must agree to use an adequate method of contraception, starting with the first dose of study treatment through 120 days after the last dose of study treatment.
    • Has intermediate-high risk, high risk, or M1 NED RCC as defined by the following pathological tumor-node-metastasis and Fuhrman grading status: 1. Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, Any Grade, N0, M0 2. High risk RCC: pT4, Any Grade N0, M0; pT, Any stage, Any Grade, N+, M0 3. M1 NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ≤1 year from nephrectomy (metachronous).
    • Has received no prior systemic therapy for advanced RCC.
    • Has undergone a partial nephroprotective or radical complete nephrectomy (and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants) with negative surgical margins.
    • Must have undergone a nephrectomy and/or metastasectomy ≥28 days prior to signing informed consent and ≤12 weeks prior to randomization.
    • Must be tumor-free as assessed by the Investigator and validated by either computed tomography (CT) or magnetic resonance imaging (MRI) scan of the brain and chest, abdomen, and pelvis and a bone scan ≤28 days from randomization.
    • Must have provided adequate tissue per the following: Nephrectomy only: tissue from nephrectomy (required); Synchronous M1 NED: tissue from nephrectomy (required) AND, metastasectomy tissue (if available); Metachronous M1 NED: tissue from metastasectomy (required) AND, nephrectomy tissue (if available).
    • Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
    • Has adequate organ function.

    Exclusion Criteria:

    • Has had major surgery, other than nephrectomy and/or resection of pre-existing metastases for M1 NED participants, within 12 weeks prior to randomization.
    • Has received prior radiotherapy for RCC.
    • Has pre-existing brain or bone metastatic lesions.
    • Has residual thrombus post nephrectomy in the vena renalis or vena cava.
    • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study treatment.
    • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy is allowed.
    • Has a known additional malignancy that is progressing or required active treatment ≤3 years ago. Exceptions include early-stage cancers (carcinoma in situ or Stage 1) treated with curative intent, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, in situ prostate cancer, or in situ breast cancer that has undergone potentially curative therapy.
    • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    • Has an active infection requiring systemic therapy.
    • Has a history of, or is currently on, dialysis.
    • Has a known history of human immunodeficiency virus (HIV) infection.
    • Has known active hepatitis B or hepatitis C virus infection.
    • Has a known history of active tuberculosis (Bacillus tuberculosis).
    • Has had a prior solid organ transplant.
    • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and/or any of its excipients.
    • Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening visit through 120 days after the last dose of study treatment.
    • Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed cell death-ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (i.e., cytotoxic T-lymphocyte-associated protein 4 [CTLA-4], OX-40, CD137 [tumor necrosis factor receptor superfamily member 9 (TNFRSF9)]) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
    • Has received prior anticancer therapy, monoclonal antibody, chemotherapy, or an investigational agent or device within 4 weeks or 5 half-lives (whichever is longer) before first dose of study treatment or not recovered (i.e., must be ≤ Grade 1 or at Baseline) from AEs due to previously administered agents.
    • Has received a live vaccine within 30 days prior to the first dose of study treatment.
    • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.

    Contact:

    • Toll Free Number
    • 1-888-577-8839

    Locations:

    • Arizona Oncology Associates, PC- HAL ( Site 8018)
    • Phoenix Arizona 85016 United States
    • USC Norris Comprehensive Cancer Center ( Site 0038)
    • Los Angeles California 90033 United States
    • UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0056)
    • San Francisco California 94158 United States
    • Sansum Clinic Research ( Site 8014)
    • Santa Barbara California 93105 United States
    • Stanford Cancer Center ( Site 0028)
    • Stanford California 94305 United States
    • Rocky Mountain Cancer Center ( Site 8010)
    • Aurora Colorado 80012 United States
    • Georgetown University Medical Center ( Site 0002)
    • Washington District of Columbia 20007 United States
    • Boca Raton Regional Hospital- Lynn Cancer Institute ( Site 0035)
    • Boca Raton Florida 33486 United States
    • Manatee Medical Research Institute ( Site 0039)
    • Bradenton Florida 34205 United States
    • Woodlands Medical Specialists, PA ( Site 8021)
    • Pensacola Florida 32503 United States
    • Northwest Georgia Oncology Centers PC ( Site 0014)
    • Marietta Georgia 30060 United States
    • Illinois Cancer Specialists ( Site 8001)
    • Niles Illinois 60714 United States
    • McFarland Clinic ( Site 0025)
    • Ames Iowa 50010-3014 United States
    • University of Iowa Hospital and Clinics ( Site 0031)
    • Iowa City Iowa 52242 United States
    • University Medical Center New Orleans ( Site 0053)
    • New Orleans Louisiana 70112 United States
    • Weinberg Cancer Institute at Franklin Square ( Site 0046)
    • Baltimore Maryland 21237 United States
    • Maryland Oncology Hematology, P.A. ( Site 8020)
    • Rockville Maryland 20850 United States
    • Beth Israel Deaconess Medical Ctr. ( Site 0044)
    • Boston Massachusetts 02215 United States
    • Dana-Farber Cancer Institute (Boston) ( Site 0007)
    • Boston Massachusetts 02215 United States
    • University of Michigan ( Site 0045)
    • Ann Arbor Michigan 48109 United States
    • Karmanos Cancer Institute ( Site 0013)
    • Detroit Michigan 48201 United States
    • Henry Ford Hospital ( Site 0032)
    • Detroit Michigan 48202 United States
    • Quest Research Institute ( Site 0036)
    • Royal Oak Michigan 48073 United States
    • Fairview Southdale Medical Oncology Clinic ( Site 0041)
    • Edina Minnesota 55435 United States
    • Minnesota Oncology Specialist, PA ( Site 8002)
    • Minneapolis Minnesota 55404 United States
    • Park Nicollet Frauenshuh Cancer Center ( Site 0020)
    • Saint Louis Park Minnesota 55426 United States
    • St. Vincent Healthcare Frontier Cancer Center ( Site 0008)
    • Billings Montana 59102 United States
    • Nebraska Cancer Specialists ( Site 0012)
    • Omaha Nebraska 68130 United States
    • Comprehensive Cancer Centers of Nevada ( Site 8013)
    • Las Vegas Nevada 89148 United States
    • Rutgers Cancer Institute of New Jersey ( Site 0059)
    • New Brunswick New Jersey 08903 United States
    • University of New Mexico Cancer Center ( Site 0043)
    • Albuquerque New Mexico 87106 United States
    • Montefiore Medical Center ( Site 0009)
    • Bronx New York 10461 United States
    • Duke University ( Site 0037)
    • Durham North Carolina 27710 United States
    • Oncology Hematology Care, Inc. ( Site 8008)
    • Cincinnati Ohio 45242 United States
    • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0052)
    • Tulsa Oklahoma 74146 United States
    • Northwest Cancer Specialists, P.C. ( Site 8006)
    • Tigard Oregon 97223 United States
    • St. Luke's University Health Network ( Site 0042)
    • Easton Pennsylvania 18045 United States
    • Abramson Cancer Center ( Site 0010)
    • Philadelphia Pennsylvania 19104 United States
    • Charleston Hematology Oncology Associates PA ( Site 8000)
    • Charleston South Carolina 29414 United States
    • Medical University of South Carolina ( Site 0033)
    • Charleston South Carolina 29425 United States
    • Avera Cancer Institute ( Site 0023)
    • Sioux Falls South Dakota 57105 United States
    • Urology Associates [Nashville, TN] ( Site 0063)
    • Nashville Tennessee 37209 United States
    • Texas Oncology-Austin Central ( Site 8003)
    • Austin Texas 78731 United States
    • Baylor Sammons Cancer Center/ Texas Oncology ( Site 8019)
    • Dallas Texas 75246 United States
    • UT Southwestern Medical Center ( Site 0003)
    • Dallas Texas 75390 United States
    • Texas Oncology-Denton South ( Site 8016)
    • Denton Texas 76210 United States
    • Texas Oncology-Memorial City ( Site 8015)
    • Houston Texas 77024 United States
    • MD Anderson Cancer Center ( Site 0065)
    • Houston Texas 77030 United States
    • UTHealth/Memorial Hermann Cancer Center ( Site 0001)
    • Houston Texas 77030 United States
    • Texas Oncology- Paris ( Site 8004)
    • Paris Texas 75460-5004 United States
    • CTRC at The University of Texas Health Science Center at San Antonio ( Site 0026)
    • San Antonio Texas 78229 United States
    • Texas Oncology-Tyler ( Site 8005)
    • Tyler Texas 75702 United States
    • Texas Oncology-Waco ( Site 8012)
    • Waco Texas 76712 United States
    • IHO Corporation- Utah Cancer Specialists ( Site 0055)
    • Salt Lake City Utah 84106 United States
    • Virginia Oncology Associates ( Site 8011)
    • Norfolk Virginia 23502 United States
    • Providence Regional Cancer Partnership ( Site 0016)
    • Everett Washington 98201 United States
    • SCCA/UW ( Site 0029)
    • Seattle Washington 98109 United States
    • Cancer Care Northwest ( Site 0021)
    • Spokane Washington 99202 United States
    • Medical Oncology Associates (Summit Cancer Centers) ( Site 0005)
    • Spokane Washington 99208 United States
    • Northwest Medical Specialties, PLLC ( Site 0034)
    • Tacoma Washington 98405 United States
    • Yakima Valley Memorial Hospital North Star Lodge ( Site 8017)
    • Yakima Washington 98902 United States
    • University of Wisconsin Carbone Cancer Center ( Site 0019)
    • Madison Wisconsin 53792 United States
    • Centro de Investigaciones Clinicas - Clinica Viedma ( Site 1102)
    • Viedma Rio Negro R8500ACE Argentina
    • Sanatorio Parque ( Site 1104)
    • Rosario Santa Fe S2000DSV Argentina
    • Instituto de Investigaciones Metabolicas -I.D.I.M.- ( Site 1113)
    • Buenos Aires C1012AAR Argentina
    • Fundacion Favaloro ( Site 1110)
    • Buenos Aires C1093AAS Argentina
    • Instituto Medico Alexander Fleming ( Site 1105)
    • Buenos Aires C1426ANZ Argentina
    • Centro Oncologico Riojano Integral ( Site 1101)
    • La Rioja F5300COE Argentina
    • Centro Oncologico de Integracion Regional. COIR ( Site 1109)
    • Mendoza M5500AYB Argentina
    • Sanatorio Britanico ( Site 1106)
    • Rosario S2000CVB Argentina
    • Instituto de Oncologia de Rosario ( Site 1100)
    • Rosario S2000KZE Argentina
    • Centro Medico San Roque ( Site 1108)
    • Tucuman T4000IAK Argentina
    • Saint George Hospital [Kogarah, Australia] ( Site 0707)
    • Kogarah New South Wales 2217 Australia
    • Macquarie University Hospital ( Site 0700)
    • Macquarie Park New South Wales 2109 Australia
    • Adelaide Cancer Centre ( Site 0703)
    • Kurralta Park South Australia 5037 Australia
    • Bendigo Cancer Centre ( Site 0704)
    • Bendigo Victoria 3550 Australia
    • Box Hill Hospital ( Site 0701)
    • Box Hill Victoria 3128 Australia
    • Ballarat Health Services ( Site 0705)
    • Ballarat 3350 Australia
    • Fiona Stanley Hospital ( Site 0702)
    • Perth 6150 Australia
    • Liga Norte Riograndense Contra o Cancer ( Site 1013)
    • Natal Rio Grande Do Norte 59075-740 Brazil
    • Universidade de Caxias do Sul ( Site 1004)
    • Caxias do Sul Rio Grande Do Sul 95070-560 Brazil
    • Hospital Bruno Born ( Site 1015)
    • Lajeado RS 95900-000 Brazil
    • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 1001)
    • Porto Alegre RS 90610-000 Brazil
    • Hospital Nossa Senhora da Conceicao ( Site 1000)
    • Porto Alegre RS 91350-200 Brazil
    • Fundacao Pio XII - Hospital de Cancer de Barretos ( Site 1002)
    • Barretos Sao Paulo 14784-400 Brazil
    • Fundacao Dr Amaral Carvalho ( Site 1005)
    • Jau Sao Paulo 17210-120 Brazil
    • Instituto do Cancer de Sao Paulo - ICESP ( Site 1010)
    • Sao Paulo SP 01246-000 Brazil
    • Casa de Saude Santa Marcelina ( Site 1006)
    • Sao Paulo SP 08270-120 Brazil
    • Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1012)
    • Curitiba 80510-130 Brazil
    • Hosp. Clinicas da Fac. de Medicina de Ribeirao Preto - USP ( Site 1016)
    • Ribeirao Preto 14048-900 Brazil
    • COT Centro Oncologico do Triangulo Ltda ( Site 1014)
    • Uberlandia 38408-150 Brazil
    • CancerCare Manitoba ( Site 0119)
    • Winnipeg Manitoba R3E 0V9 Canada
    • Dr. Leon Richard Oncology Centre ( Site 0106)
    • Moncton New Brunswick E1C 8X3 Canada
    • William Osler Health System ( Site 0115)
    • Brampton Ontario L6R 3J7 Canada
    • Juravinski Cancer Centre ( Site 0117)
    • Hamilton Ontario L8V 5C2 Canada
    • London Regional Cancer Program - London HSC ( Site 0107)
    • London Ontario N6A 4L6 Canada
    • Lakeridge Health ( Site 0108)
    • Oshawa Ontario L1G 2B9 Canada
    • Niagara Health System - St. Catharines ( Site 0120)
    • St. Catharines Ontario L2S 0A9 Canada
    • CIUSSS du Saguenay-Lac-St-Jean ( Site 0113)
    • Chicoutimi Quebec G7H 5H6 Canada
    • CISSS-CA Hotel Dieu de Levis ( Site 0111)
    • Lévis Quebec G6V 3Z1 Canada
    • CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0118)
    • Montreal Quebec H1T 2M4 Canada
    • St-Jerome Medical Research Inc ( Site 0103)
    • St-Jerome Quebec J7Z 5T3 Canada
    • Allan Blair Cancer Centre ( Site 0116)
    • Regina Saskatchewan S4T 7T1 Canada
    • Saskatoon Cancer Centre ( Site 0105)
    • Saskatoon Saskatchewan S7N 4H4 Canada
    • Instituto Nacional del Cancer ( Site 0912)
    • Santiago Region Metropolitana 8380455 Chile
    • Centro Oncologico Antofagasta ( Site 0914)
    • Antofagasta 1240000 Chile
    • Hospital Regional de La Serena ( Site 0907)
    • La Serena 1710216 Chile
    • Hospital Regional Rancagua Libertador Bernardo O Higgins ( Site 0910)
    • Rancagua 2820000 Chile
    • Health and Care Chile ( Site 0901)
    • Santiago 7500006 Chile
    • Fundacion Arturo Lopez Perez FALP ( Site 0902)
    • Santiago 7500921 Chile
    • Iram Cancer Research ( Site 0909)
    • Santiago 7630372 Chile
    • Hospital Militar de Santiago ( Site 0911)
    • Santiago 7850000 Chile
    • Pontificia Universidad Catolica de Chile ( Site 0904)
    • Santiago 8330032 Chile
    • Hospital Clinico Universidad de Chile ( Site 0905)
    • Santiago 8380456 Chile
    • Sociedad de Investigaciones Medicas Limitadas ( Site 0913)
    • Temuco 4810469 Chile
    • Oncocentro ( Site 0900)
    • Vina del Mar 2520598 Chile
    • Hospital Pablo Tobon Uribe. ( Site 0805)
    • Medellin Antioquia 050034 Colombia
    • Clinica de la Costa Ltda. ( Site 0804)
    • Barranquilla Atlantico 080020 Colombia
    • Sociedad de Hematologia y Oncologia del Cesar ( Site 0809)
    • Valledupar Cesar 200001 Colombia
    • Instituto Nacional de Cancerologia E.S.E ( Site 0807)
    • Bogota Cundinamarca 111161 Colombia
    • Oncologos del Occidente S.A. ( Site 0800)
    • Pereira Risaralda 661002 Colombia
    • Fundacion CardioInfantil Instituto de Cardiologia ( Site 0803)
    • Bogota 110131 Colombia
    • Oncomedica S.A. ( Site 0801)
    • Monteria 230002 Colombia
    • FN Brno. ( Site 1501)
    • Brno 625 00 Czechia
    • Nemocnice Novy Jicin a.s. Clen skupiny AGEL ( Site 1506)
    • Novy Jicin 741 01 Czechia
    • Fakultni nemocnice Olomouc ( Site 1502)
    • Olomouc 775 20 Czechia
    • Fakultni nemocnice Ostrava ( Site 1507)
    • Ostrava 708 52 Czechia
    • Thomayerova nemocnice ( Site 1505)
    • Praha 4 140 59 Czechia
    • Fakultni nemocnice v Motole ( Site 1504)
    • Praha 5 150 06 Czechia
    • Nemocnice Na Bulovce ( Site 1503)
    • Praha 8 180 81 Czechia
    • HYKS ( Site 2300)
    • Helsinki 00290 Finland
    • Keski-Suomen keskussairaala ( Site 2303)
    • Jyvaskyla 40620 Finland
    • Oulun yliopistollinen sairaala - OYS ( Site 2304)
    • Oulu 90220 Finland
    • TAYS ( Site 2301)
    • Tampere 33520 Finland
    • TYKS ( Site 2302)
    • Turku 20521 Finland
    • ICO Centre Paul Papin ( Site 2208)
    • Angers 49055 France
    • CHU Besancon - Hopital Jean Minjoz ( Site 2200)
    • Besancon 25000 France
    • Hopital Saint Andre ( Site 2202)
    • Bordeaux 33075 France
    • Hopital La Timone ( Site 2204)
    • Marseille 13005 France
    • CHU Saint-Eloi ( Site 2203)
    • Montpellier 34295 France
    • Centre Antoine Lacassagne ( Site 2211)
    • Nice 06189 France
    • Hopital Europeen Georges Pompidou ( Site 2206)
    • Paris 75908 France
    • Hospices Civils de Lyon Centre Hospitalier Lyon Sud ( Site 2212)
    • Pierre Benite 69310 France
    • Centre Eugene Marquis ( Site 2209)
    • Rennes 35042 France
    • Centre Rene Gauducheau ICO ( Site 2207)
    • Saint Herblain 44805 France
    • Institut Claudius Regaud IUCT Oncopole ( Site 2201)
    • Toulouse 31059 France
    • Campus Charite Mitte ( Site 2120)
    • Berlin 10117 Germany
    • Helios Klinikum Berlin Buch ( Site 2125)
    • Berlin 13125 Germany
    • Universitaetsklinikum Bonn ( Site 2110)
    • Bonn 53127 Germany
    • Universitaetsklinikum der Technischen Universitaet Dresden ( Site 2113)
    • Dresden 01307 Germany
    • Universitatsklinikum Dusseldorf ( Site 2108)
    • Dusseldorf 40225 Germany
    • Universitaetsklinikum Erlangen. Waldkrankenhaus ( Site 2102)
    • Erlangen 91058 Germany
    • Universitaetsklinikum Essen ( Site 2116)
    • Essen 45122 Germany
    • Universitaetsklinikum Frankfurt ( Site 2121)
    • Frankfurt 60590 Germany
    • Universitaetsklinikum Freiburg ( Site 2119)
    • Freiburg 79106 Germany
    • Universitaetsklinikum Hamburg-Eppendorf ( Site 2118)
    • Hamburg 20246 Germany
    • Universitaetsklinikum Jena. ( Site 2104)
    • Jena 07747 Germany
    • Universitaetsklinikum Schleswig Holstein ( Site 2109)
    • Luebeck 23538 Germany
    • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz ( Site 2111)
    • Mainz 55131 Germany
    • Studienpraxis Urologie ( Site 2115)
    • Nuertingen 72622 Germany
    • Krankenhaus der Barmherzigen Brueder Trier ( Site 2117)
    • Trier 54292 Germany
    • Universitaetsklinikum Tuebingen ( Site 2100)
    • Tuebingen 72076 Germany
    • Beaumont Hospital ( Site 1611)
    • Dublin D04 Y8V0 Ireland
    • St Vincents University Hospital ( Site 1610)
    • Dublin D04 Y8V0 Ireland
    • University Hospital Waterford ( Site 1614)
    • Waterford X91 ER8E Ireland
    • Ospedale San Luigi Gonzaga ( Site 2010)
    • Orbassano Torino 10043 Italy
    • Medical Oncology Ospedale San Donato ( Site 2004)
    • Arezzo 52100 Italy
    • Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 2012)
    • Meldola 47014 Italy
    • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2005)
    • Milano 20133 Italy
    • Istituto Europeo di Oncologia ( Site 2000)
    • Milano 20141 Italy
    • Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 2006)
    • Modena 41125 Italy
    • Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2003)
    • Napoli 80131 Italy
    • Istituto Nazionale Tumori Regina Elena ( Site 2009)
    • Roma 00144 Italy
    • Nagoya University Hospital ( Site 0431)
    • Nagoya Aichi 466-8560 Japan
    • Sapporo Medical University Hospital ( Site 0424)
    • Sapporo Hokkaido 060-8543 Japan
    • Kagawa University Hospital ( Site 0419)
    • Kita-gun Kagawa 761-0793 Japan
    • Japan Community Health care Organization Sendai Hospital ( Site 0430)
    • Sendai Miyagi 981-8501 Japan
    • Nara Medical University Hospital ( Site 0416)
    • Kashihara Nara 634-8522 Japan
    • Kindai University Hospital ( Site 0411)
    • Osakasayama Osaka 589-8511 Japan
    • Osaka Rosai Hospital ( Site 0418)
    • Sakai Osaka 591-8025 Japan
    • Saitama Medical University International Medical Center ( Site 0404)
    • Hidaka Saitama 350-1298 Japan
    • Yamaguchi University Hospital ( Site 0406)
    • Ube Yamaguchi 755-8505 Japan
    • Akita University Hospital ( Site 0433)
    • Akita 010-8543 Japan
    • Harasanshin Hospital ( Site 0402)
    • Fukuoka 812-0033 Japan
    • Kyushu University Hospital ( Site 0413)
    • Fukuoka 812-8582 Japan
    • Kumamoto University Hospital ( Site 0434)
    • Kumamoto 860-8556 Japan
    • Nagano Municipal Hospital ( Site 0429)
    • Nagano 381-8551 Japan
    • Niigata University Medical & Dental Hospital ( Site 0421)
    • Niigata 951-8520 Japan
    • Osaka International Cancer Institute ( Site 0401)
    • Osaka 541-8567 Japan
    • Osaka City University Hospital ( Site 0428)
    • Osaka 545-8586 Japan
    • Toranomon Hospital ( Site 0426)
    • Tokyo 105-8470 Japan
    • Nippon Medical School Hospital ( Site 0400)
    • Tokyo 113-8603 Japan
    • Keio University Hospital ( Site 0407)
    • Tokyo 160-8582 Japan
    • Toyama University Hospital ( Site 0432)
    • Toyama 930-0194 Japan
    • National Cancer Center ( Site 0304)
    • Goyang-si Gyeonggi-do 10408 Korea, Republic of
    • Seoul National University Hospital ( Site 0302)
    • Seoul 03080 Korea, Republic of
    • Severance Hospital Yonsei University Health System ( Site 0303)
    • Seoul 03722 Korea, Republic of
    • Asan Medical Center ( Site 0300)
    • Seoul 05505 Korea, Republic of
    • Samsung Medical Center ( Site 0301)
    • Seoul 06351 Korea, Republic of
    • Amphia Ziekenhuis Breda ( Site 1901)
    • Breda 4819 EV Netherlands
    • Maastricht Universitair Medisch Centrum - MUMC ( Site 1902)
    • Maastricht 6229 HX Netherlands
    • Franciscus Gasthuis ( Site 1903)
    • Rotterdam 3045 PM Netherlands
    • Mazowiecki Szpital Onkologiczny ( Site 1316)
    • Wieliszew Mazowieckie 05-135 Poland
    • Szpital Specjalistyczny w Koscierzynie Sp. z o.o. ( Site 1322)
    • Koscierzyna Pomorskie 83-400 Poland
    • Szpital Specjalistyczny w Brzozowie Podkarpacki Osrodek Onkologiczny ( Site 1309)
    • Brzozow 36-200 Poland
    • Wojewodzki Szpital Specjalistyczny nr 4 w Bytomiu ( Site 1307)
    • Bytom 41-902 Poland
    • Wojewodzkie Centrum Onkologii Copernicus ( Site 1304)
    • Gdansk 80-219 Poland
    • Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o. ( Site 1302)
    • Gdynia 81-519 Poland
    • Centrum Onkologii Instytut im. Marii Skłodowskiej Curie ( Site 1323)
    • Gliwice 44-101 Poland
    • Przychodnia Lekarska Komed ( Site 1306)
    • Konin 62-500 Poland
    • Centrum Onkologii Instytut im. Marii Sklodowskiej Curie ( Site 1310)
    • Krakow 31-115 Poland
    • Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 1315)
    • Lublin 20-090 Poland
    • Europejskie Centrum Zdrowia Otwock Szpital im. Fryderyka Chopina ( Site 1324)
    • Otwock 05-400 Poland
    • Szpital Kliniczny Przemienienia Panskiego UM im. K. Marcinkowskiego ( Site 1311)
    • Poznan 60-569 Poland
    • Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 1305)
    • Torun 87-100 Poland
    • Centrum Medyczne Onkologii I Hipertermii ( Site 1321)
    • Warszawa 02-793 Poland
    • Wojskowy Instytut Medyczny Centralny Szpital Medyczny MON ( Site 1300)
    • Warszawa 04-141 Poland
    • Ivanovo Regional Oncology Dispensary ( Site 1204)
    • Ivanovo 153040 Russian Federation
    • Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1210)
    • Krasnoyarsk 660133 Russian Federation
    • N.N. Blokhin NMRCO ( Site 1206)
    • Moscow 115478 Russian Federation
    • Russian Scientific Center of Roentgenoradiology ( Site 1201)
    • Moscow 117997 Russian Federation
    • National Medical Research Radiology Centre ( Site 1200)
    • Moscow 125284 Russian Federation
    • Bayandin Murmansk Regional Clinical Hospital ( Site 1214)
    • Murmansk 183057 Russian Federation
    • Omsk Clinical Oncology Dispensary ( Site 1209)
    • Omsk 644013 Russian Federation
    • Russian Scientific Center of Radiology and Surgical Technologies ( Site 1205)
    • Saint Petersburg 197758 Russian Federation
    • Tomsk Scientific Research Institute of Oncology ( Site 1208)
    • Tomsk 634028 Russian Federation
    • Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1217)
    • Ufa 450054 Russian Federation
    • Clinical Hospital Bashkirsky Medical State University ( Site 1202)
    • Ufa 450083 Russian Federation
    • Hospital Universitario Infanta Cristina ( Site 1805)
    • Badajoz 06080 Spain
    • Hospital de la Santa Creu i Sant Pau ( Site 1807)
    • Barcelona 08026 Spain
    • Hospital de Girona Dr. Josep Trueta ( Site 1806)
    • Girona 17007 Spain
    • Hospital Universitario Gregorio Maranon ( Site 1801)
    • Madrid 28007 Spain
    • Hospital Universitario Ramon y Cajal ( Site 1800)
    • Madrid 28034 Spain
    • Hospital Universitario Virgen de la Victoria ( Site 1808)
    • Malaga 29010 Spain
    • Clinica Universitaria de Navarra ( Site 1803)
    • Pamplona 31008 Spain
    • Instituto Valenciano de Oncologia ( Site 1804)
    • Valencia 46009 Spain
    • Hospital Universitario y Politecnico La Fe de Valencia ( Site 1809)
    • Valencia 46026 Spain
    • China Medical University Hospital ( Site 0200)
    • Taichung 40447 Taiwan
    • Taichung Veterans General Hospital ( Site 0204)
    • Taichung 407 Taiwan
    • National Taiwan University Hospital ( Site 0202)
    • Taipei 10002 Taiwan
    • Taipei Veterans General Hospital ( Site 0201)
    • Taipei 112 Taiwan
    • Chang Gung Medical Foundation. Linkou ( Site 0203)
    • Taoyuan 333 Taiwan
    • North Staffordshire Hospital in Stoke-on-Trent ( Site 1601)
    • Stoke-On-Trent Staffordshire ST4 6QG United Kingdom
    • Western General Hospital ( Site 1600)
    • Edinburgh EH4 2XU United Kingdom
    • The Beatson West of Scotland Cancer Centre ( Site 1605)
    • Glasgow G12 0YN United Kingdom
    • Royal Free Hospital ( Site 1609)
    • London NW3 2QG United Kingdom
    • St George s Healthcare Trust ( Site 1608)
    • London SW17 0QT United Kingdom
    • Charing Cross Hospital ( Site 1607)
    • London W6 8RF United Kingdom
    • The Christie NHS Foundation Trust ( Site 1602)
    • Manchester M20 4BX United Kingdom
    • The James Cook University Hospital ( Site 1606)
    • Middlesbrough TS4 3BW United Kingdom

    View trial on ClinicalTrials.gov


    {{footer-clinical-trials-navigation}}
    Published September 11, 2017
  • A Randomized Phase 2 Study of MK-2206 versus Everolimus in Refractory Renal Cell Carcinoma.

    Activation of the phosphoinisitide-3 kinase (PI3K) pathway through mutation and constitutive upregulation have been described in renal cell carcinoma (RCC), making it an attractive target for therapeutic intervention.

    Published January 11, 2017
  • A randomized phase 2 trial of CRLX101 in combination with bevacizumab versus standard of care in patients with advanced renal cell carcinoma.

    Nanoparticle-drug conjugates (NDC) enhance drug delivery to tumors. Gradual payload release inside cancer cells augments antitumor activity while reducing toxicity. CRLX101 is a novel NDC containing camptothecin a potent inhibitor of topoisomerase I and the hypoxia-inducible factors (HIF) 1α and 2α.

    Published October 6, 2017
  • A rapid and systemic complete response to stereotactic body radiation therapy and pembrolizumab in a patient with metastatic renal cell carcinoma.

    Stereotactic body radiation therapy (SBRT) of local tumor would induce an abscopal effect that has been observed in several kinds of human cancers; one important mechanism may involve the improved activation of the host immune system.

    Published July 5, 2017
  • A review on the management of small renal masses: active surveillance versus surgery.

    Despite the rise of small renal tumour (SRMs) diagnosis and related surgeries, death rate of kidney cancer is increasing, suggesting a non-optimal management of SRMs. Active Surveillance (AS) for kidney cancer was introduced to face this paradox.

    Published November 22, 2017
  • A systematic search strategy identifies cubilin as independent prognostic marker for renal cell carcinoma.

    There is an unmet clinical need for better prognostic and diagnostic tools for renal cell carcinoma (RCC).

    Human Protein Atlas data resources, including the transcriptomes and proteomes of normal and malignant human tissues, were searched for RCC-specific proteins and cubilin (CUBN) identified as a candidate.

    Published January 11, 2017
  • Activation of the kynurenine pathway predicts poor outcome in patients with clear cell renal cell carcinoma.

    To investigate the expression of the kynurenine (KYN) pathway components and the prognostic role of the KYN-to-tryptophan ratio (KTR) in a cohort of patients with clear cell renal cell carcinoma (ccRCC).

    Published April 4, 2017
  • Active heavy cigarette smoking is associated with poor survival in Japanese patients with advanced renal cell carcinoma: sub-analysis of the multi-institutional national database of the Japanese Urological Association.

    The association between cigarette smoking and survival in patients with renal cell carcinoma is not well studied. We examined the impact of cigarette smoking on survival of patients with advanced renal cell carcinoma using the multi-institutional national database of the Japanese Urological Association.

    Published November 14, 2017
  • Adjuvant therapy for locally advanced renal cell carcinoma: A meta-analysis and systematic review.

    Many adjuvant therapies have been widely used in an attempt to reduce the local recurrence or distant metastasis of locally advanced renal cell carcinoma (RCC) after surgical resection. However, the benefits of adjuvant therapy remain controversial.

    Published November 17, 2017
  • Adjuvant therapy in renal cell carcinoma: does higher risk for recurrence improve the chance for success?

    The success of targeted therapies, including inhibitors of the vascular endothelial growth factor pathway or the mammalian target of rapamycin, in the treatment of metastatic renal cell carcinoma (RCC) led to interest in testing their efficacy in the adjuvant setting.

    Published December 8, 2017
  • Adjuvant therapy in renal cell carcinoma.

    Several drugs have demonstrated clinical activity in metastatic renal cell carcinoma (mRCC). The identification of key metabolic pathways has led to the development of novel targeted therapies which have drastically changed the treatment paradigm of mRCC.

    Published October 18, 2017
  • Advances in medical imaging for the diagnosis and management of common genitourinary cancers.

    Medical imaging of the 3 most common genitourinary (GU) cancers-prostate adenocarcinoma, renal cell carcinoma, and urothelial carcinoma of the bladder-has evolved significantly during the last decades.

    Published May 30, 2017
  • An In-vivo Prospective Study of the Diagnostic Yield and Accuracy of Optical Biopsy Compared with Conventional Renal Mass Biopsy for the Diagnosis of Renal Cell Carcinoma: The Interim Analysis.

    Lack of accuracy in preoperative imaging leads to overtreatment of benign renal masses (RMs) or indolent renal cell carcinomas (RCCs). Optical coherence tomography (OCT) is real time and high resolution, enabling quantitative analysis through attenuation coefficient (μOCT, mm(-1)).

    Published October 30, 2017
  • Angiogenic, inflammatory and immunologic markers in predicting response to sunitinib in metastatic renal cell carcinoma.

    The objective of this prospective study was to identify baseline angiogenic and inflammatory markers in serum as well as the baseline levels of immune cells in whole blood to predict progression free survival in patients with metastatic renal cell carcinoma treated with sunitinib.

    Published July 15, 2017
  • Application of the American Society of Clinical Oncology frameworks to compare tyrosine kinase inhibitors used in first line treatment of metastatic renal cell carcinoma: Had we solved the mystery?

    The approval of multiple biological therapies as a first line treatment for metastatic renal cell carcinoma (mRCC) in the last decade have led to the selection of the best treatment between these drugs, especially tyrosine kinase inhibitors (TKIs), a great challenge to oncologists and patients.

    Published September 6, 2017
  • AR-Signaling in Human Malignancies: Prostate Cancer and Beyond.

    In the 1940s Charles Huggins reported remarkable palliative benefits following surgical castration in men with advanced prostate cancer, and since then the androgen receptor (AR) has remained the main therapeutic target in this disease.

    Published January 17, 2017
  • Are We Using the Best Tumor Size Cut-Points for Renal Cell Carcinoma Staging?

    To compare the predictive ability for oncologic outcomes among current tumor size cut-points and clinically relevant alternatives in order to determine which are optimal.

    Patients who underwent radical or partial nephrectomy between 1970-2010 for T1-2Nx/N0M0 renal cell carcinoma (RCC) were identified.

    Published April 24, 2017
  • Association between coffee consumption and risk of renal cell carcinoma: A Meta-analysis.

    The risk of renal cell carcinoma (RCC) in individuals who regularly drink coffee is controversial. Several antioxidant compounds in coffee have been proposed to reduce the risk of RCC, while the findings from several studies raise concerns regarding a potential increased risk of RCC with coffee consumption.

    Published September 22, 2017
  • Association of decreased mean platelet volume with renal cell carcinoma.

    Renal cell carcinoma (RCC) is the third most common genitourinary cancer. Activated platelets play a pivotal role in cancer development and progression. Altered mean platelet volume (MPV) has been reported in several malignancies.

    Published July 6, 2017
  • Association of high cost sharing and targeted therapy initiation among elderly Medicare patients with metastatic renal cell carcinoma.

    High out-of-pocket costs may limit access to oral therapies covered by patients' prescription drug benefits. We explored financial barriers to treatment initiation in patients newly diagnosed with metastatic renal cell carcinoma (mRCC) by comparing Medicare Part D patients with low out-of-pocket costs due to receipt of full low-income subsidies (LIS beneficiaries) to their counterparts who were responsible for more than 25% cost sharing during Medicare's initial coverage phase (non-LIS beneficiaries).

    Published December 4, 2017
  • Axitinib in sequential therapy in metastatic renal cell carcinoma.

    Efficacy of new molecularly targeted drugs in the treatment of renal cell carcinoma (RCC), confirmed in clinical studies in relation to survival and prolongation of time to progression, has became a big chance for patients with metastatic renal cell cancer.

    Published April 12, 2017
  • Biological Features of a Renal Cell Carcinoma Cell Line Derived from Spinal Metastasis.

    The establishment of a metastatic renal cell carcinoma (mRCC) cell line can facilitate the search for molecular mechanisms involved in RCC metastasis. A novel human mRCC cell line, designated RCC96, was established from an mRCC of the spine from a 65-year-old Chinese man.

    Published January 11, 2017
  • Biology and treatment of renal tumours in childhood.

    In Europe, almost 1000 children are diagnosed with a malignant renal tumour each year. The vast majority of cases are nephroblastoma, also known as Wilms' tumour (WT). Most children are treated according to Société Internationale d'Oncologie Pédiatrique Renal Tumour Study Group (SIOP-RTSG) protocols with pre-operative chemotherapy, surgery, and post-operative treatment dependent on stage and histology.

    Published December 20, 2016
  • Cabosun II: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma

    {{header-clinical-trials-navigation}}

    Cabosun Ii: Cabozantinib Versus Sunitinib for Metastatic Variant Histology Renal Cell Carcinoma


    Condition: Malignant Neoplasms of Urinary Tract, Renal Cell Carcinoma, Chromophobe Renal Cell Carcinoma, Metastatic Renal Cell Carcinoma, Papillary Renal Cell Carcinoma, Renal Cell Carcinoma Associated With Xp11.2 Translocations/TFE3 Gene Fusions, Sarcomatoid Renal Cell Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Unclassified Renal Cell Carcinoma

    Intervention:

    • Drug: Cabozantinib
    • Drug: Sunitinib Malate

    Purpose: The goal of this clinical research study is to compare the safety and effectiveness of cabozantinib and sunitinib when given to patients with metastatic (has spread) variant histology renal cell carcinoma (vhRCC), a type of kidney cancer. This is an investigational study. Cabozantinib and sunitinib are both FDA approved and commercially available for the treatment of advanced kidney cancer, including vhRCC. The study doctor can explain how the study drugs are designed to work. Up to 84 participants will be enrolled in this study. All will take part at MD Anderson.

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03541902

    Sponsor: M.D. Anderson Cancer Center

    Primary Outcome Measures:

    • Measure: Progression-Free Survival (PFS) Evaluated Using RECIST 1.1 Criteria
    • Time Frame: From randomization up to the time of disease progression or death up to two years
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Objective Response Rate (ORR) Evaluated Using RECIST 1.1 Criteria
    • Time Frame: From randomization up to the time of disease progression or death up to two years
    • Safety Issue:
    • Measure: Overall Survival (OS)
    • Time Frame: From randomization to death or last contact if still alive up to two years
    • Safety Issue:
    • Measure: Adverse Event Rates
    • Time Frame: Start of study drug up to 30 days after last dose of study drug
    • Safety Issue:

    Estimated Enrollment: 84

    Study Start Date: May 15, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum N/A
    • Gender: All

    Inclusion Criteria:

    • 1. The subject has a histologic or cytologic diagnosis of a variant histology renal cell carcinoma including papillary, chromophobe, Xp.11 translocation, undifferentiated, or unclassified which is treatment naïve or has previously been treated with one systemic treatment line not containing any vascular endothelial growth factor antibody or vascular endothelial growth factor receptor tyrosine kinase inhibitors. The patient may have received treatment with immune checkpoint therapy including nivolumab as a single agent or nivolumab plus ipilimumab in combination. Previous treatment with mammalian target of rapamycin agents such as temsirolimus or everolimus is acceptable. 2. Measurable disease per RECIST v1.1 as determined by the investigator. 3. The subject has had an assessment of all known disease sites eg, by computerized tomography (CT) scan, magnetic resonance imaging (MRI), bone scan as appropriate, within 28 days before the first dose of cabozantinib or sunitinib. 4. The subject is >/=18 years old on the day of consent; 5. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of /= 1500/mm^3 without colony stimulating factor support; b.White blood cell count >/= 2500/mm^3 (>/= 2.5 GI/L). c.Platelets >/=100,000/mm^3; d.Hemoglobin >/= 9 g/dL; e. Bilirubin/= 2.8 g/dl g.Serum creatinine/= 30 mL/min (>/= 0.5 mL/sec) using the Cockcroft-Gault equation: Males: (140
    • age) x weight (kg)/(serum creatinine [mg/dL] × 72) Females: [(140
    • age) x weight (kg)/(serum creatinine [mg/dL] × 72)] × 0.85 h.Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP)

    Exclusion Criteria:

    1. The subject has a variant histology that includes renal medullary carcinoma or collecting duct renal cell carcinoma. Any clear cell component in the tumor will lead to exclusion.
    2. The subject has received any previous anti-angiogenic agent. Prior treatment with cabozantinib.
    3. Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before the first dose of study treatment. Systemic treatment with radionuclides within 6 weeks before the first dose of study treatment. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible;
    4. The subject has received any other type of investigational agent within 28 days before the first dose of study treatment;
    5. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks before the first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of the start of study treatment;
    6. Concomitant anticoagulation with oral anticoagulants (eg, warfarin, direct thrombin and Factor Xa inhibitors) or platelet inhibitors (eg, clopidogrel). Allowed anticoagulants are the following: o Low-dose aspirin for cardioprotection (per local applicable guidelines) is permitted. o Low-dose low molecular weight heparins (LMWH) are permitted. Anticoagulation with therapeutic doses of LMWH is allowed in subjects without known brain metastases who are on a stable dose of LMWH for at least 6 weeks before first dose of study treatment, and who have had no clinically significant hemorrhagic complications from the anticoagulation regimen or the tumor.
    7. The subject has prothrombin time (PT)/INR or partial thromboplastin time (PTT) tes>/=1.3 X the laboratory ULN within 7 days before the first dose of study treatment.
    8. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions: Cardiovascular disorders: a.Congestive heart failure New York Heart Association Class 3 or 4, unstable angina pectoris, serious cardiac arrhythmias. b.Uncontrolled hypertension defined as sustained blood pressure (BP) > 150 mm Hg systolic or > 100 mm Hg diastolic despite optimal antihypertensive treatment. c.Stroke (including transient ischemic attack [TIA]), myocardial infarction (MI), or other ischemic event, or thromboembolic event (eg, deep venous thrombosis, pulmonary embolism) within 6 months before first dose.
    9. Continuation of 8:Gastrointestinal (GI) disorders including those associated with a high risk of perforation or fistula formation: The subject has evidence of tumor invading the GI tract, active peptic ulcer disease, inflammatory bowel disease (eg, Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis, acute obstruction of the pancreatic duct or common bile duct, or gastric outlet obstruction. Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before first dose.
    10. Continuation of 8: Clinically significant hematuria, hematemesis, or hemoptysis of > 0.5 teaspoon (2.5 ml) of red blood, or other history of significant bleeding (eg, pulmonary hemorrhage) within 12 weeks before first dose. Cavitating pulmonary lesion(s) or known endotracheal or endobronchial disease manifestation. Lesions invading or encasing any major blood vessels. Other clinically significant disorders that would preclude safe study participation. Serious non-healing wound/ulcer/bone fracture. Uncompensated/symptomatic hypothyroidism. Moderate to severe hepatic impairment (Child-Pugh B or C).
    11. Major surgery (eg, GI surgery, removal or biopsy of brain metastasis) within 8 weeks before first dose of study treatment. Complete wound healing from major surgery must have occurred 1 month before first dose and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before first dose. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
    12. Corrected QT interval calculated by the Fridericia formula (QTcF) > 500 ms per electrocardiogram (ECG) within 28 days before first dose of study treatment
    13. Pregnant or lactating females.
    14. Inability to swallow tablets
    15. Previously identified allergy or hypersensitivity to components of the study treatment formulations.
    16. Diagnosis of another malignancy within 2 years before first dose of study treatment, except for superficial skin cancers, or localized, low grade tumors deemed cured and not treated with systemic therapy. Patients with Gleason 6 (3+3) prostate cancer with previous treatment or on active surveillance may also be allowed on protocol.
    17. The subject requires chronic concomitant treatment with strong CYP3A4 inducers (eg, dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital, and St. John's Wort).

    Contact:

    • Matthew Campbell, MD
    • 713-792-2830

    Locations:

    • M D Anderson Cancer Center
    • Houston Texas 77030 United States
    • MD Anderson Regional Care Center-Katy
    • Houston Texas 77094 United States
    • MD Anderson Regional Care Center-Sugar Land
    • Sugar Land Texas 77478 United States

    View trial on ClinicalTrials.gov


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    Published June 20, 2018
  • Cabozantinib for Renal Cell Carcinoma: Current and Future Paradigms.

    Cabozantinib was approved by the FDA in April 2016 for the treatment of advanced renal cancer, pretreated with at least one prior antiangiogenic therapy. This is the first agent in the therapy of kidney cancer to show a statistically significant improvement in all three endpoints of clinical efficacy, response rate, progression free survival, and overall survival (OS), in a phase III randomized trial.

    Published March 21, 2017
  • Cabozantinib for the treatment of kidney cancer.

    Cabozantinib is a small molecule tyrosine kinase inhibitor that initially showed activity in medullary thyroid cancer and was recently approved by the Food and Drug Administration for the treatment of metastatic renal cell carcinoma after progression on first line therapy.

    Published June 29, 2017
  • caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)

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    caBozantinib in cOllectiNg ductS Renal Cell cArcInoma (BONSAI)


    Condition: Collecting Duct Carcinoma (Kidney)

    Intervention:

    • Drug: cabozantinib

    Purpose: This is a single-arm, phase II trial (monocentric) study designed to determine To evaluate activity of Cabozantinib in terms of ORR according to the RECIST 1.1 criteria in Metastatic Collecting Duct Renal Cell Carcinoma

    Study Type: Interventional

    Clinical Trials Identifier NCT 8-digits: NCT03354884

    Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

    Primary Outcome Measures:

    • Measure: Objective response rate (ORR)
    • Time Frame: 30 Month
    • Safety Issue:

    Secondary Outcome Measures:

    • Measure: Progression free Survival (PFS)
    • Time Frame: 30 Month
    • Safety Issue:
    • Measure: Overall survival (OS)
    • Time Frame: 30 Month
    • Safety Issue:
    • Measure: Safety and Tolerability (Adverse Events)
    • Time Frame: 30 Month
    • Safety Issue:

    Estimated Enrollment: 23

    Study Start Date: January 12, 2018

    Phase: Phase 2

    Eligibility:

    • Age: minimum 18 Years maximum 85 Years
    • Gender: All

    Inclusion Criteria:

    • 1. Written Informed Consent Form 2. Unresectable, advanced or metastatic collecting ducts carcinoma untreated with any systemic agent for advanced disease 3. Measurable disease as defined by RECIST v1.1 criteria 4. Age ≥18 years 5. ECOG Performance Status 0-1 6. Any of the following laboratory test findings:
    • Hemoglobin > 9 g/dL (5.6 mmol/L)
    • WBC > 2,000/mm3
    • Neutrophils > 1,500/mm3
    • Platelets > 100,000/mm3
    • AST or ALT < 3 x ULN (< 5 x ULN if liver metastases are present)
    • Total Bilirubin < 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
    • Serum creatinine < 1.5 x upper limit of normal (ULN) or creatinine clearance ≥ 40 mL/min (measured or calculated by Cockroft-Gault formula)
    • Lipase < 2.0 x the upper limit of normal and no radiologic or clinical evidence of pancreatitis
    • PT-INR/PTT ≤ 1.5 x upper limit of normal [Patients who are being therapeutically anticoagulated with an agent such as coumadin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in these parameters exists.] For patients on warfarin, close monitoring of at least weekly evaluations will be performed, until INR is stable based on a measurement at pre-dose, as defined by the local standard of care 7. Availability of a representative FFPE tumor specimen collected within 24 months of starting first-line cabozantinib that enables the definitive diagnosis of CDC (the archival specimen must contain adequate viable tumor tissue to enable candidate biomarkers status; the specimen may consist of a tissue block or at least 15 unstained serial sections; for core needle biopsy specimens, at least two cores should be available for evaluation) 8. Sexually active fertile subjects and their partners must agree to use medically accepted methods of contraception (eg, barrier methods, including male condom, female condom, or diaphragm with spermicidal gel) during the study and for 4 months after the last dose of study treatment 9. Female subjects of childbearing potential must not be pregnant at screening

    Exclusion Criteria:

    1. Previous therapy for advanced disease; any medical adjuvant treatment must have been stopped at least six months before entry into the study
    2. History of any one or more of the following cardiovascular conditions within the past 6 months: cardiac angioplasty or stenting, myocardial infarction, unstable angina, coronary artery bypass graft surgery, symptomatic peripheral vascular disease, Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
    3. Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
    4. History of cerebrovascular accidents, including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
    5. Major surgery or trauma within 28 days before to study entry; the such as catheter placement not considered to be major surgery).
    6. Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 3 months before randomization.
    7. Evidence of active bleeding or bleeding diathesis and/or clinically-significant GI bleeding within 6 months before the first dose of study treatment; 3 months for pulmonary hemorrhage and patients with tumor invading or encasing any major blood vessels.
    8. Patients with GI disorders associated with a high risk of perforation or fistula formation.
    9. Subjects with clinically relevant ongoing complications from prior radiation therapy.
    10. Any serious and/or unstable pre-existing medical, psychiatric, or other conditions that could interfere with subject's safety, provision of informed consent, or compliance to study procedures.
    11. Previous or ongoing treatment (except for adjuvant therapies) with any of the following anti-cancer therapies: chemotherapy, immunotherapy, target therapies, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of Cabozantinib
    12. Inability to swallow tablets or capsules.

    Contact:

    • Giuseppe Procopio, MD
    • +390223904450

    Location:

    • Giuseppe Procopio
    • Milan 20133 Italy

    View trial on ClinicalTrials.gov


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    Published June 20, 2018
  • Cabozantinib in metastatic renal cell carcinoma: latest findings and clinical potential.

    Since the advent of immunotherapy revolutionized the treatment of metastatic renal cell carcinoma (mRCC), the attention of oncologists has been unavoidably shifted from tyrosine kinase inhibitors (TKIs) to immune checkpoint blockade, with the associated risk of listing cabozantinib as just one of many available TKIs.

    Published October 20, 2017
  • Cabozantinib: A Multi-targeted Oral Tyrosine Kinase Inhibitor.

    Cabozantinib is an oral, small-molecule, multitargeted tyrosine kinase inhibitor (TKI) that may confer an advantage over other TKIs that target a single receptor. It has been approved by the United States Food and Drug Administration for the treatment of both advanced renal cell carcinoma and progressive metastatic medullary thyroid cancer, and is being investigated for a wide array of other malignancies.

    Published January 2, 2018
  • Can partial nephrectomy provide equal oncological efficiency and safety compared with radical nephrectomy in patients with renal cell carcinoma (≥4cm)? A propensity score-matched study.

    Although partial nephrectomy (PN) is the standard treatment for localized clinical T1a renal cell carcinoma (RCC), treatment of larger renal tumors is controversial. We evaluated the oncological outcomes and perioperative complications after radical and PN for RCC ≥4cm.

    Published March 21, 2017
  • Cannabinoid receptor 2 as a novel target for promotion of renal cell carcinoma prognosis and progression.

    Renal cell carcinoma (RCC) is the most common malignancy of urogenital system, and patients with RCC may face a poor prognosis. However, limited curable therapeutic options are currently available. The aim of this study is to investigate the role of Cannabinoid receptor 2 (CB2) in RCC progression.

    Published October 18, 2017
  • Characterization and Impact of TERT Promoter Region Mutations on Clinical Outcome in Renal Cell Carcinoma.

    Mutations in the promoter region of the TERT gene have been detected in a variety of cancers. These mutations can potentially lead to unlimited cell divisions and result in poor clinical prognosis.

    To determine the role and relevance of TERT promoter region mutations in both clear cell (ccRCC) and non-clear cell (nccRCC) renal cell carcinoma using ultra-deep and whole-genome sequencing methods on primary tumor samples.

    Published October 6, 2017
  • CheckMate 025 Randomized Phase 3 Study: Outcomes by Key Baseline Factors and Prior Therapy for Nivolumab Versus Everolimus in Advanced Renal Cell Carcinoma.

    The randomized, phase 3 CheckMate 025 study of nivolumab (n=410) versus everolimus (n=411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR).

    Published March 31, 2017
  • Clear cell renal cell carcinoma: Validation of WHO/ISUP grading.

    In 2012, the International Society of Urological Pathology (ISUP) introduced a novel grading system for clear cell and papillary renal cell carcinoma (RCC) based upon increasing nucleolar prominence in grades 1 to 3, with the presence of extreme nuclear pleomorphism and/or tumour giant cells and/or sarcomatoid and/or rhabdoid differentiation as criteria for grade 4.

    Published August 4, 2017
  • Clinical and immunologic correlates of response to PD-1 blockade in a patient with metastatic renal medullary carcinoma.

    Renal medullary carcinoma (RMC) is a rare kidney tumor that occurs in adolescent and young adults, typically in association with sickle cell trait. RMC exhibits rapid disease progression, frequent metastases at diagnosis, and dismal clinical outcomes.

    Published January 25, 2017
  • Clinical Characteristics of Patients With Renal Cell Carcinoma and Metastasis to the Thyroid Gland.

    Renal cell carcinoma (RCC) is the most common malignancy to metastasize to the thyroid gland. The aims of this study are as follows: (1) to analyze the clinical characteristics of patients with thyroid involvement of RCC and (2) in patients with RCC thyroid metastasis, to determine whether RCC metastasis to glandular organs only portends a better prognosis compared with other patterns of RCC metastasis.

    Published December 18, 2017
  • Clinical correlates and prognostic value of different metastatic sites in metastatic renal cell carcinoma.

    Real life data on the clinical correlates and prognostic value of metastatic sites in metastatic renal cell carcinoma (RCC) are needed. This parameter was assessed in RCC patients registered within the surveillance, epidemiology and end results (SEER) database.

    Published August 28, 2017
  • Clinical development of mTor inhibitors for renal cancer.

    Renal cell carcinoma (RCC) accounts for approximately 3% of adult malignancies and 90-95% of neoplasms arising from the kidney. In the last 10 years, clinical trials have established multitargeted tyrosine kinase inhibitors (TKIs) as the standard first-line treatment in patients with metastatic disease.

    Published October 4, 2017

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