Clinical trial NCT05239728: A Study of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Clear Cell Renal Cell Carcinoma Post Nephrectomy (MK-6482-022)
Official title: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Renal Cell
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1(PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Hypoxia inducible factor 2 alpha (HIF-2 alpha)
Hypoxia inducible factor 2α (HIF-2α)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2022-02-15
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy.

The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).


Eligibility criteria: The main inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of RCC with clear cell component per American Joint Committee on Cancer (AJCC) (8th Edition), with or without sarcomatoid features
* Has intermediate-high risk, high risk, or M1 no evidence of disease (NED) RCC as defined by the following pathological tumor-node metastasis and tumor grading:

  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, ≤2 years from nephrectomy (metachronous)
* Has undergone complete resection of the primary tumor (partial or radical nephrectomy) and complete resection of solid, isolated, soft tissue metastatic lesion(s) in M1 NED participants
* Must have undergone a nephrectomy and/or metastasectomy ≤12 weeks prior to randomization
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days before randomization.
* Male participants must agree to continue contraception at least 7 days after the last dose of belzutifan/placebo
* 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 pembrolizumab or at least 30 days after last dose of belzutifan/placebo, whichever occurs last
* Has adequate organ function

Exclusion Criteria:

* Has had a major surgery, other than nephrectomy plus resection of preexisting metastases for M1 NED participants, within 4 weeks prior to randomization
* Has a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen
* Has clinically significant cardiovascular disease within 6 months from first dose of study intervention
* Has other clinically significant disorders such as: serious active nonhealing wound/ulcer/bone fracture; requirement for hemodialysis or peritoneal dialysis
* Has preexisting brain or bone metastatic lesions
* Has received prior systemic therapy for RCC
* Has received prior radiotherapy for RCC
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention; administration of killed vaccines are allowed
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
* Has a known additional malignancy (other than RCC treated with nephrectomy and/or metastasectomy) that is progressing or has required active treatment within the past 3 years
* 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 history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection, requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection, a known history of Hepatitis B or known active Hepatitis C virus infection
* Has had an allogenic tissue/solid organ transplant

Primary outcomes:
measure: Disease-Free Survival (DFS)
timeFrame: Up to approximately 54 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 89 months
measure: Number of Participants Who Experience at Least One Adverse Event (AE)
timeFrame: Up to approximately 66 weeks
measure: Number of Participants Who Discontinue Study Treatment Due to an AE
timeFrame: Up to approximately 54 weeks
measure: Disease Recurrence-Specific Survival 1 (DRSS1)
timeFrame: Up to approximately 54 months
measure: Disease Recurrence-Specific Survival 2 (DRSS2)
timeFrame: Up to approximately 54 months
measure: Change From Baseline in Health-Related Quality-of-Life (HRQoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score
timeFrame: Baseline (Day 1) and up to approximately 36 months
measure: Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
timeFrame: Baseline (Day 1) and up to approximately 36 months
measure: Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score
timeFrame: Baseline (Day 1) and up to approximately 36 months
measure: Change From Baseline in Disease Symptoms Using the Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score
timeFrame: Baseline (Day 1) and up to approximately 36 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic in Arizona - Phoenix ( Site 3554)
state: Arizona
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center ( Site 3567)
state: California
city: La Jolla
country: United States
facility: Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
state: California
city: Orange
country: United States
facility: University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)
state: California
city: Palo Alto
country: United States
facility: Stanford Cancer Center ( Site 3523)
state: California
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus ( Site 3514)
state: Colorado
city: Grand Junction
country: United States
facility: St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 3562)
state: Colorado
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 3534)
state: District of Columbia
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center ( Site 3540)
state: Florida
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)
state: Georgia
city: Fort Wayne
country: United States
facility: Parkview Research Center at Parkview Regional Medical Center ( Site 3526)
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 3571)
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute-GU ( Site 3505)
state: Massachusetts
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 3502)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University-Internal Medicine/Oncology ( Site 3531)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center-Research ( Site 3506)
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)
state: Nebraska
city: Englewood
country: United States
facility: Englewood Hospital and Medical Center ( Site 3557)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 3541)
state: New Jersey
city: Lake Success
country: United States
facility: Monter Cancer Center ( Site 3560)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 3539)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 3568)
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center ( Site 3528)
state: New York
city: Columbus
country: United States
facility: The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
state: Ohio
city: Bala-Cynwyd
country: United States
facility: MidLantic urology ( Site 3501)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center-GU Oncology ( Site 3535)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center ( Site 3551)
state: South Dakota
city: Germantown
country: United States
facility: The West Clinic, PLLC dba West Cancer Center ( Site 3522)
state: Tennessee
city: Nashville
country: United States
facility: Urology Associates ( Site 3512)
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 3529)
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center-Urology ( Site 3569)
state: Texas
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 3525)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)
state: Washington
city: Blacktown
country: Australia
facility: Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002)
state: New South Wales
city: Macquarie University
country: Australia
facility: Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)
state: New South Wales
city: North Tamworth
country: Australia
facility: Tamworth Hospital-North West Cancer Centre ( Site 0006)
state: New South Wales
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
state: Queensland
city: Elizabeth Vale
country: Australia
facility: Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)
state: South Australia
city: Heidelberg
country: Australia
facility: Austin Health-Cancer Clinical Trials Centre ( Site 0005)
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital-Medical Oncology ( Site 0004)
state: Western Australia
city: Fortaleza
country: Brazil
facility: Hospital São Carlos-Oncocentro Ce ( Site 0104)
state: Ceara
city: Belo Horizonte
country: Brazil
facility: Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Instituto do Câncer e Transplante de Curitiba ( Site 0102)
state: Parana
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)
state: Rio Grande Do Sul
city: Ribeirão Preto
country: Brazil
facility: Hospital de Clínicas de Ribeirão Preto ( Site 0112)
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)
city: Panagyurishte
country: Bulgaria
facility: MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)
state: Pazardzhik
city: Sofia
country: Bulgaria
facility: MHAT Serdika-Second Department of Medical Oncology ( Site 0203)
state: Sofia (stolitsa)
city: Plovdiv
country: Bulgaria
facility: Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)
city: Calgary
country: Canada
facility: Tom Baker Cancer Center ( Site 3706)
state: Alberta
city: Vancouver
country: Canada
facility: BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)
state: Ontario
city: London
country: Canada
facility: Victoria Hospital & Children's Hospital - London Health Scie-London Regional Cancer Program ( Site 3
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 3703)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 3709)
state: Quebec
city: Quebec
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer ( Site 0307)
state: Araucania
city: Puerto Montt
country: Chile
facility: Clínica Puerto Montt ( Site 0309)
state: Los Lagos
city: Valdivia
country: Chile
facility: Oncocentro Valdivia ( Site 0312)
state: Los Rios
city: Santiago
country: Chile
facility: FALP-UIDO ( Site 0302)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 0306)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0305)
state: Region M. De Santiago
city: Viña del Mar
country: Chile
facility: ONCOCENTRO APYS-ACEREY ( Site 0301)
state: Valparaiso
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 0303)
city: Bengbu
country: China
facility: Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 0438)
state: Anhui
city: Hefei
country: China
facility: Second Affiliated hospital of Anhui Medical University-Urology ( Site 0416)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 0435)
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital-Urology ( Site 0407)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer hospital-Urinary Surgery ( Site 0406)
state: Beijing
city: Beijing
country: China
facility: First Medical Center of Chinese PLA General Hospital ( Site 0415)
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital ( Site 0414)
state: Chongqing
city: Chongqing
country: China
facility: Army Medical Center of People's Liberation Army ( Site 0439)
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0445)
state: Fujian
city: Guangzhou
country: China
facility: SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417)
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0403)
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0402)
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Cancer Hospital-Urology ( Site 0441)
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0423)
state: Hubei
city: Wuhan
country: China
facility: Wuhan Union Hospital ( Site 0430)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital-Urinary surgery ( Site 0419)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 0421)
state: Hunan
city: NanJing
country: China
facility: Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University ( Site 0432)
state: Jiangxi
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University ( Site 0443)
state: Jiangxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center-Urology department ( Site 0401)
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)
state: Shanghai
city: Shanghai
country: China
facility: Huadong Hospital Affiliated to Fudan University ( Site 0405)
state: Shanghai
city: Cheng Du
country: China
facility: West China Hospital of Sichuan University-Urology Surgery ( Site 0410)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital ( Site 0422)
state: Tianjin
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University ( Site 0428)
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital-Urology ( Site 0426)
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo First Hospital-Urology ( Site 0433)
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0425)
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0506)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomédica S.A.S ( Site 0501)
state: Cordoba
city: Bogotá
country: Colombia
facility: Administradora Country S.A. - Clinica del Country ( Site 0504)
state: Distrito Capital De Bogota
city: Brno
country: Czechia
facility: Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)
state: Brno-mesto
city: Brno
country: Czechia
facility: Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)
state: Brno-mesto
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)
state: Moravskoslezsky Kraj
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)
state: Olomoucky Kraj
city: Prague
country: Czechia
facility: Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)
state: Praha 4
city: Praha
country: Czechia
facility: Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)
state: Praha 5
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala ( Site 0805)
state: Pirkanmaa
city: Oulu
country: Finland
facility: Oulun yliopistollinen sairaala ( Site 0802)
state: Pohjois-Pohjanmaa
city: Kuopio
country: Finland
facility: Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)
state: Pohjois-Savo
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)
state: Uusimaa
city: Turku
country: Finland
facility: Turku University Hospital ( Site 0801)
state: Varsinais-Suomi
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903)
state: Alsace
city: Chambray Les Tours
country: France
facility: ROC37 ( Site 0910)
state: Centre
city: Besançon
country: France
facility: CHU Besançon-Medical oncology ( Site 0904)
state: Doubs
city: Villejuif
country: France
facility: Gustave Roussy ( Site 0907)
state: Ile-de-France
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)
state: Ille-et-Vilaine
city: Angers
country: France
facility: Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)
state: Maine-et-Loire
city: Lyon
country: France
facility: CENTRE LEON BERARD-Medical oncology ( Site 0902)
state: Rhone-Alpes
city: Paris
country: France
facility: Hôpital Saint-Louis ( Site 0905)
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)
city: Singen
country: Germany
facility: Hegau-Bodensee-Klinikum Singen ( Site 1016)
state: Baden-Wurttemberg
city: Tübingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 1002)
state: Baden-Wurttemberg
city: Munich
country: Germany
facility: klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
state: Bayern
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen ( Site 1024)
state: Nordrhein-Westfalen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn ( Site 1006)
state: Nordrhein-Westfalen
city: Düsseldorf
country: Germany
facility: Universitaetsklinikum Duesseldorf ( Site 1017)
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 1004)
state: Nordrhein-Westfalen
city: Münster
country: Germany
facility: Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)
state: Nordrhein-Westfalen
city: Homburg
country: Germany
facility: Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)
state: Saarland
city: Halle
country: Germany
facility: Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie (
state: Sachsen-Anhalt
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)
state: Sachsen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera ( Site 1015)
state: Thuringen
city: Jena
country: Germany
facility: Universitätsklinikum Jena ( Site 1007)
state: Thuringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch ( Site 1011)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)
city: Athens
country: Greece
facility: Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)
state: Attiki
city: Athens
country: Greece
facility: Metropolitan Hospital-2nd Oncology Dept ( Site 1104)
state: Attiki
city: Chaidari
country: Greece
facility: ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)
state: Attiki
city: Thessaloniki
country: Greece
facility: Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center-Oncology Department ( Site 1105)
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)
state: Csongrad
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)
state: Gyor-Moson-Sopron
city: Budapest
country: Hungary
facility: Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)
state: Pest
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)
state: Somogy
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)
city: Dublin 24
country: Ireland
facility: Tallaght University Hospital ( Site 1402)
state: Dublin
city: Dublin 4
country: Ireland
facility: St. Vincent's University Hospital ( Site 1401)
state: Dublin
city: Cork
country: Ireland
facility: Cork University Hospital ( Site 1404)
city: Dublin
country: Ireland
facility: Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 1505)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology ( Site 1502)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center-Oncology ( Site 1506)
city: Petah-Tikva
country: Israel
facility: Rabin Medical Center-Oncology ( Site 1503)
city: Ramat Gan
country: Israel
facility: Sheba Medical Center-ONCOLOGY ( Site 1504)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center-Oncology ( Site 1501)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)
state: Emilia-Romagna
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)
state: Lazio
city: Milano
country: Italy
facility: Ospedale San Raffaele-Oncologia Medica ( Site 1606)
state: Lombardia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)
state: Lombardia
city: Orbassano
country: Italy
facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)
state: Piemonte
city: Bari
country: Italy
facility: A.O.U.C. Policlinico di Bari ( Site 1607)
state: Puglia
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)
state: Toscana
city: Arezzo
country: Italy
facility: Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)
city: Bologna
country: Italy
facility: IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)
city: Terni
country: Italy
facility: Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)
city: Toyoake
country: Japan
facility: Fujita Health University ( Site 1709)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1704)
state: Chiba
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center ( Site 1718)
state: Chiba
city: Toon
country: Japan
facility: Ehime University Hospital ( Site 1714)
state: Ehime
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital ( Site 1702)
state: Hokkaido
city: Sapporo
country: Japan
facility: Hokkaido University Hospital ( Site 1701)
state: Hokkaido
city: Yokohama
country: Japan
facility: Kanagawa cancer center ( Site 1703)
state: Kanagawa
city: Kashihara
country: Japan
facility: Nara Medical University Hospital ( Site 1712)
state: Nara
city: Sakai
country: Japan
facility: Bell Land General Hospital ( Site 1710)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 1711)
state: Osaka
city: Hamamatsu
country: Japan
facility: Hamamatsu University Hospital ( Site 1708)
state: Shizuoka
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 1706)
state: Tokyo
city: Toyoma
country: Japan
facility: Toyama University Hospital ( Site 1713)
state: Toyama
city: Fukuoka
country: Japan
facility: Kyushu University Hospital ( Site 1715)
city: Kagoshima
country: Japan
facility: Kagoshima University Hospital ( Site 1719)
city: Kumamoto
country: Japan
facility: Kumamoto University ( Site 1716)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 1720)
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital ( Site 1705)
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University Adachi Medical Center ( Site 1717)
city: Tokyo
country: Japan
facility: Keio university hospital ( Site 1707)
city: Wakayama
country: Japan
facility: Wakayama Medical University Hospital ( Site 1721)
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center-Center for Urologic Cancer ( Site 2604)
state: Kyonggi-do
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital-Urology ( Site 2602)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center-Oncology ( Site 2601)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2603)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 1804)
state: Kuala Lumpur
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang ( Site 1806)
state: Pulau Pinang
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 1805)
state: Sarawak
city: Mexico City
country: Mexico
facility: INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)
state: Distrito Federal
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1
state: Distrito Federal
city: Guadalajara
country: Mexico
facility: Terapias Integrales del Riñon SA de CV ( Site 1910)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)
state: Jalisco
city: Guadalajara
country: Mexico
facility: BRCR Global Mexico - Guadalajara-Research ( Site 1908)
state: Jalisco
city: Monterrey
country: Mexico
facility: Filios Alta Medicina ( Site 1903)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: iCan Oncology Center Centro Medico AVE ( Site 1901)
state: Nuevo Leon
city: Santiago de Queretaro
country: Mexico
facility: Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)
state: Queretaro
city: Santiago de Querétaro
country: Mexico
facility: BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)
state: Queretaro
city: Culiacán
country: Mexico
facility: Centro de Oncología Personalizada ( Site 1911)
state: Sinaloa
city: Oaxaca
country: Mexico
facility: Centro de Investigacion Clinica de Oaxaca ( Site 1904)
city: Puebla
country: Mexico
facility: Oncocenter ( Site 1909)
city: Arnhem
country: Netherlands
facility: Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)
state: Gelderland
city: Nijmegen
country: Netherlands
facility: Radboudumc ( Site 3120)
state: Gelderland
city: Maastricht
country: Netherlands
facility: Maastricht UMC+ ( Site 3104)
state: Limburg
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)
state: Noord-Brabant
city: Eindhoven
country: Netherlands
facility: Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)
state: Noord-Brabant
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC ( Site 3105)
state: Noord-Holland
city: Hilversum
country: Netherlands
facility: Tergooiziekenhuizen, locatie Hilversum ( Site 3102)
state: Noord-Holland
city: Hoofddorp
country: Netherlands
facility: Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)
state: Noord-Holland
city: Zwolle
country: Netherlands
facility: Isala, locatie Zwolle-Oncology ( Site 3111)
state: Overijssel
city: Den Haag
country: Netherlands
facility: Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)
state: Zuid-Holland
city: Leidschendam
country: Netherlands
facility: Haaglanden MC - locatie Antoniushove ( Site 3117)
state: Zuid-Holland
city: Schiedam
country: Netherlands
facility: Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)
state: Zuid-Holland
city: Groningen
country: Netherlands
facility: University Medical Center Groningen ( Site 3121)
city: Utrecht
country: Netherlands
facility: St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)
city: Auckland
country: New Zealand
facility: Auckland City Hospital-Cancer & Blood Research ( Site 2003)
city: Wrocław
country: Poland
facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)
state: Kujawsko-pomorskie
city: Torun
country: Poland
facility: MICS Centrum Medyczne Torun ( Site 2305)
state: Kujawsko-pomorskie
city: Tarnow
country: Poland
facility: Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)
state: Malopolskie
city: Siedlce
country: Poland
facility: Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Luxmed Onkologia sp. z o. o. ( Site 2303)
state: Mazowieckie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)
state: Podkarpackie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 2304)
state: Wielkopolskie
city: Poznań
country: Poland
facility: Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 2312)
state: Wielkopolskie
city: Koszalin
country: Poland
facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)
state: Zachodniopomorskie
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)
state: Zachodniopomorskie
city: București
country: Romania
facility: Centrul medical Focus ( Site 2407)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 2406)
state: Cluj
city: Florești
country: Romania
facility: Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)
state: Cluj
city: Craiova
country: Romania
facility: Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2401)
state: Dolj
city: Otopeni
country: Romania
facility: Radiology Therapeutic Center-Oncology ( Site 2404)
state: Ilfov
city: Timișoara
country: Romania
facility: Cabinet Medical Oncomed ( Site 2403)
state: Timis
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 3601)
state: Central Singapore
city: Singapore
country: Singapore
facility: National University Hospital ( Site 3602)
state: South West
city: Girona
country: Spain
facility: Institut Català d'Oncologia (ICO) - Girona ( Site 2707)
state: Gerona
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)
state: Madrid, Comunidad De
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)
state: Madrid, Comunidad De
city: Valencia
country: Spain
facility: Fundación Instituto Valenciano de Oncología ( Site 2705)
state: Valenciana, Comunitat
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)
city: Lugo
country: Spain
facility: Hospital Lucus Augusti-Oncology ( Site 2706)
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos-Oncology Department ( Site 2703)
city: Malaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)
city: Stockholm
country: Sweden
facility: Karolinska Universitetssjukhuset Solna ( Site 2802)
state: Stockholms Lan
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)
state: Uppsala Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset ( Site 2801)
state: Vastra Gotalands Lan
city: Kaohsiung Niao Sung Dist
country: Taiwan
facility: Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)
state: Kaohsiung
city: Taipei City
country: Taiwan
facility: Tri-Service General Hospital ( Site 2908)
state: Taipei
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital ( Site 2901)
city: Taichung
country: Taiwan
facility: China Medical University Hospital-Department of Urology ( Site 2907)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 2902)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2904)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 2903)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)
city: Bangkok
country: Thailand
facility: Chulalongkorn University ( Site 3005)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital ( Site 3001)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 3002)
state: Krung Thep Maha Nakhon
city: Hatyai
country: Thailand
facility: Songklanagarind hospital ( Site 3004)
state: Songkhla
city: Yenimahalle
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)
state: Ankara
city: Istanbul- Fatih
country: Turkey
facility: Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)
state: Istanbul
city: Adana
country: Turkey
facility: Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)
city: Ankara
country: Turkey
facility: Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)
city: Ankara
country: Turkey
facility: Ankara University Hospital Cebeci ( Site 3209)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi-oncology hospital ( Site 3203)
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)
city: Izmir
country: Turkey
facility: Ege University Medicine of Faculty-Medical Oncology ( Site 3202)
city: London
country: United Kingdom
facility: Royal Free Hospital ( Site 3304)
state: England
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 3301)
state: England
city: Nottingham
country: United Kingdom
facility: City Hospital, Nottingham University Hospitals ( Site 3303)
state: England
city: Glasgow
country: United Kingdom
facility: Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)
state: Glasgow City
city: London
country: United Kingdom
facility: Charing Cross Hospital ( Site 3302)
state: Hammersmith And Fulham
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)
state: London, City Of
city: Swansea
country: United Kingdom
facility: Singleton Hospital ( Site 3306)
state: Wales
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: