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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