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
  • 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, Neurologicka klinika
  • Olomouc Czechia
  • Thomayerova nemocnice
  • Praha 4 Czechia
  • Fakultni nemocnice v Motole
  • Praha 5 Czechia
  • Nemocnice Na Bulovce
  • Praha 8 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
  • ESAI trail site 4
  • Stuttgart Baden Wuerttemberg 70174 Germany
  • ESAI trail site 1
  • Tuebingen Baden Wuerttemberg 72076 Germany
  • ESAI trail site 7
  • München Bayern 81377 Germany
  • ESAI trail site 6
  • Frankfurt Hessen 60590 Germany
  • ESAI trail site 14
  • Greifswald Mecklenburg-Vorpommern Germany
  • ESAI trail site 8
  • Hannover Niedersachsen 30625 Germany
  • ESAI trail site 13
  • Münster Nordrhein Westfalen 48149 Germany
  • ESAI trail site 9
  • Koblenz Rheinland Pfalz 56068 Germany
  • ESAI trail site 2
  • Homburg/Saar Saarland 66421 Germany
  • ESAI trail site 5
  • Berlin 12200 Germany
  • ESAI trail site 3
  • Dresden 01307 Germany
  • ESAI trail site 11
  • Harburg Germany
  • ESAI trail site 10
  • Heidelberg Germany
  • ESAI trail site 12
  • Ulm 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
  • Assaf Harofeh Medical Center
  • Be'er Ya'aqov Israel
  • Rambam MC
  • Haifa Israel
  • Hadassah University Hospital - Ein Kerem
  • Jerusalem Israel
  • Sapir Medical Center, Meir Hospital
  • Kfar-Saba Israel
  • Rabin Medical Center-Beilinson Campus
  • Petah Tikva 49100 Israel
  • Chaim Sheba Medical Center
  • Ramat-Gan 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
  • I.R.C.S.S Fondazione Maugeri
  • 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
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika
  • Lodz Poland
  • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • 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
  • FSBI "Institution of Surgery n.a. A.V. Vishnevskiy" of MoH of the Russian Federation
  • Moscow Russian Federation
  • FSBSI Russian Oncological Scientific Center n.a. N.N. Blokhin
  • Moscow Russian Federation
  • Moscow Oncology Research Institute n.a. P.A. Herzen
  • Moscow Russian Federation
  • FBHI Privolzhskiy District Medical Centre FMBA of Russia
  • Nizhniy Novgorod Russian Federation
  • SBIH of N Novgorod Region "Clinical Diagnostic Center
  • 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 i Provincial 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
  • Hospital Clinico Universitario de Valencia
  • 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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