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)

April 18, 2024 updated by: Merck Sharp & Dohme LLC

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)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital-Blacktown Cancer and Haematology Centre - Medical Oncology ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: 0286705077
      • Macquarie University, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: +61298122956
      • North Tamworth, New South Wales, Australia, 2340
        • Recruiting
        • Tamworth Hospital-North West Cancer Centre ( Site 0006)
        • Contact:
          • Study Coordinator
          • Phone Number: +61 2 6767 7760
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si
        • Contact:
          • Study Coordinator
          • Phone Number: +61736467983
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Recruiting
        • Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)
        • Contact:
          • Study Coordinator
          • Phone Number: 61882820833
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • Austin Health-Cancer Clinical Trials Centre ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: +6139493352
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital-Medical Oncology ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: 61861526530
  • Brazil
      • Sao Paulo, Brazil, 01321-001
        • Completed
        • BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)
    • Ceara
      • Fortaleza, Ceara, Brazil, 60135-237
        • Recruiting
        • Hospital São Carlos-Oncocentro Ce ( Site 0104)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 85 991122944
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Recruiting
        • Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 31 993092597
    • Parana
      • Curitiba, Parana, Brazil, 80510-130
        • Recruiting
        • Instituto do Câncer e Transplante de Curitiba ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 55 41 992057755
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Recruiting
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: +558440095595
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: +55 51 33572092
    • Sao Paulo
      • Ribeirão Preto, Sao Paulo, Brazil, 14048900
        • Recruiting
        • Hospital de Clínicas de Ribeirão Preto ( Site 0112)
        • Contact:
          • Study Coordinator
          • Phone Number: +551699174
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Recruiting
        • Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)
        • Contact:
          • Study Coordinator
          • Phone Number: +35932277240
    • Pazardzhik
      • Panagyurishte, Pazardzhik, Bulgaria, 4500
        • Active, not recruiting
        • MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1301
        • Active, not recruiting
        • MHAT Serdika-Second Department of Medical Oncology ( Site 0203)
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Recruiting
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3
        • Contact:
          • Study Coordinator
          • Phone Number: 418-525-4444
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Center ( Site 3706)
        • Contact:
          • Study Coordinator
          • Phone Number: 4035213166
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)
        • Contact:
          • Study Coordinator
          • Phone Number: 6048776000
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Completed
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital & Children's Hospital - London Health Scie-London Regional Cancer Program ( Site 3
        • Contact:
          • Study Coordinator
          • Phone Number: 519-685-8500
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • Princess Margaret Cancer Centre ( Site 3703)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-946-4501
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Completed
        • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)
      • Montréal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 3709)
        • Contact:
          • Study Coordinator
          • Phone Number: 5149341934
  • Chile
      • Antofagasta, Chile, 1240000
        • Recruiting
        • Bradford Hill Norte ( Site 0303)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 9419 8125
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigación del Cáncer ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 7431 6500
    • Los Lagos
      • Puerto Montt, Los Lagos, Chile, 5500243
        • Recruiting
        • Clínica Puerto Montt ( Site 0309)
        • Contact:
          • Study Coordinator
          • Phone Number: +56 9 9863 4501
    • Los Rios
      • Valdivia, Los Rios, Chile, 5112129
        • Recruiting
        • Oncocentro Valdivia ( Site 0312)
        • Contact:
          • Study Coordinator
          • Phone Number: +56992195434
    • Region M. De Santiago
      • Santiago, Region M. De Santiago, Chile, 7510032
        • Recruiting
        • Oncovida ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +56972151681
      • Santiago, Region M. De Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill ( Site 0305)
        • Contact:
          • Study Coordinator
          • Phone Number: +56229490970
      • Santiago, Region M. De Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0302)
        • Contact:
          • Study Coordinator
          • Phone Number: 56224218596
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • Recruiting
        • ONCOCENTRO APYS-ACEREY ( Site 0301)
        • Contact:
          • Study Coordinator
          • Phone Number: +56323320850
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • Recruiting
        • Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 0438)
        • Contact:
          • Study Coordinator
          • Phone Number: 13955259747
      • Hefei, Anhui, China, 230000
        • Active, not recruiting
        • Second Affiliated hospital of Anhui Medical University-Urology ( Site 0416)
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital-Urology ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613910688432
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Urinary Surgery ( Site 0406)
        • Contact:
          • Study Coordinator
          • Phone Number: +86-10-88196023
      • Beijing, Beijing, China, 100021
        • Recruiting
        • Cancer Hospital Chinese Academy of Medical Science-Urinary Surgery ( Site 0435)
        • Contact:
          • Study Coordinator
          • Phone Number: +010 88788787
      • Beijing, Beijing, China, 100853
        • Recruiting
        • First Medical Center of Chinese PLA General Hospital ( Site 0415)
        • Contact:
          • Study Coordinator
          • Phone Number: 861068182255
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Recruiting
        • Chongqing University Cancer Hospital ( Site 0414)
        • Contact:
          • Study Coordinator
          • Phone Number: 13883029913
      • Chongqing, Chongqing, China, 400042
        • Recruiting
        • Army Medical Center of People's Liberation Army ( Site 0439)
        • Contact:
          • Study Coordinator
          • Phone Number: 13508331099
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 0445)
        • Contact:
          • Study Coordinator
          • Phone Number: 13235907575
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • SUN YAT-SEN UNIVERSITY CANCER CENTRE-Urology Surgery ( Site 0417)
        • Contact:
          • Study Coordinator
          • Phone Number: 13822735659
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 0403)
        • Contact:
          • Study Coordinator
          • Phone Number: 13719007083
      • Guangzhou, Guangdong, China, 510289
        • Recruiting
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 0402)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613600054833
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital-Urology ( Site 0441)
        • Contact:
          • Study Coordinator
          • Phone Number: 15936270111
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital-Urinary surgery ( Site 0419)
        • Contact:
          • Study Coordinator
          • Phone Number: 13907110640
      • Wuhan, Hubei, China, 430000
        • Active, not recruiting
        • Tongji Hospital Tongji Medical,Science & Technology-oncology ( Site 0423)
      • Wuhan, Hubei, China, 430022
        • Active, not recruiting
        • Wuhan Union Hospital ( Site 0430)
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital ( Site 0421)
        • Contact:
          • Study Coordinator
          • Phone Number: 8673189762510
    • Jiangsu
      • NanJing, Jiangsu, China, 210000
        • Active, not recruiting
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University ( Site 0432)
        • Contact:
          • Study Coordinator
          • Phone Number: 8618279116868
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University ( Site 0443)
        • Contact:
          • Study Coordinator
          • Phone Number: 18979116622
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • Recruiting
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)
        • Contact:
          • Study Coordinator
          • Phone Number: +029 85323473
    • Shanghai
      • Shanghai, Shanghai, China, 200040
        • Recruiting
        • Huadong Hospital Affiliated to Fudan University ( Site 0405)
        • Contact:
          • Study Coordinator
          • Phone Number: 13301807126
      • Shanghai, Shanghai, China, 200001
        • Recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)
        • Contact:
          • Study Coordinator
          • Phone Number: 8613912562057
      • Shanghai, Shanghai, China, 200000
        • Active, not recruiting
        • Fudan University Shanghai Cancer Center-Urology department ( Site 0401)
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University-Urology Surgery ( Site 0410)
        • Contact:
          • Study Coordinator
          • Phone Number: 13881749152
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Recruiting
        • Tianjin Medical University Cancer Institute and Hospital ( Site 0422)
        • Contact:
          • Study Coordinator
          • Phone Number: +86 (022) 23340123-6416
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University ( Site 0428)
        • Contact:
          • Study Coordinator
          • Phone Number: 13957120101
      • Hangzhou, Zhejiang, China, 310014
        • Recruiting
        • Zhejiang Provincial People's Hospital-Urology ( Site 0426)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613958036776
      • Ningbo, Zhejiang, China, 315010
        • Recruiting
        • Ningbo First Hospital-Urology ( Site 0433)
        • Contact:
          • Study Coordinator
          • Phone Number: 13967897956
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 0425)
        • Contact:
          • Study Coordinator
          • Phone Number: +8613626582653
  • Colombia
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Recruiting
        • Clinica de la Costa S.A.S. ( Site 0506)
        • Contact:
          • Study Coordinator
          • Phone Number: +573008457696
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: +573128385292
    • Cordoba
      • Monteria, Cordoba, Colombia, 230001
        • Recruiting
        • Oncomédica S.A.S ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +573105394868
    • Distrito Capital De Bogota
      • Bogotá, Distrito Capital De Bogota, Colombia, 110221
        • Completed
        • Administradora Country S.A. - Clinica del Country ( Site 0504)
  • Czechia
      • Hradec Kralove, Czechia, 500 05
        • Recruiting
        • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: +420727854666
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Recruiting
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)
        • Contact:
          • Study Coordinator
          • Phone Number: +420543136226
      • Brno, Brno-mesto, Czechia, 656 91
        • Completed
        • Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)
    • Moravskoslezsky Kraj
      • Ostrava, Moravskoslezsky Kraj, Czechia, 708 52
        • Recruiting
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)
        • Contact:
          • Study Coordinator
          • Phone Number: +420597372111
    • Olomoucky Kraj
      • Olomouc, Olomoucky Kraj, Czechia, 779 00
        • Recruiting
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +420588444295
    • Praha 4
      • Prague, Praha 4, Czechia, 140 59
        • Recruiting
        • Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +420261083530
    • Praha 5
      • Praha, Praha 5, Czechia, 150 06
        • Recruiting
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)
        • Contact:
          • Study Coordinator
          • Phone Number: 420734236410
  • Finland
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Recruiting
        • Tampereen yliopistollinen sairaala ( Site 0805)
        • Contact:
          • Study Coordinator
          • Phone Number: +358 3 31163082
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90220
        • Recruiting
        • Oulun yliopistollinen sairaala ( Site 0802)
        • Contact:
          • Study Coordinator
          • Phone Number: +35883152870
    • Pohjois-Savo
      • Kuopio, Pohjois-Savo, Finland, 70210
        • Recruiting
        • Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)
        • Contact:
          • Study Coordinator
          • Phone Number: +358447172943
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Active, not recruiting
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Recruiting
        • Turku University Hospital ( Site 0801)
        • Contact:
          • Study Coordinator
          • Phone Number: +35823130729
  • France
      • Paris, France, 75010
        • Recruiting
        • Hôpital Saint-Louis ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142494949
      • Paris, France, 75015
        • Recruiting
        • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)
        • Contact:
          • Study Coordinator
          • Phone Number: +33156092431
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • Recruiting
        • Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0903)
        • Contact:
          • Study Coordinator
          • Phone Number: 0368767359
    • Centre
      • Chambray Les Tours, Centre, France, 37170
        • Recruiting
        • ROC37 ( Site 0910)
        • Contact:
          • Study Coordinator
          • Phone Number: 0247602574
    • Doubs
      • Besançon, Doubs, France, 25000
        • Recruiting
        • CHU Besançon-Medical oncology ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: 0033(0)370632005
    • Ile-de-France
      • Villejuif, Ile-de-France, France, 94800
        • Recruiting
        • Gustave Roussy ( Site 0907)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142115026
    • Ille-et-Vilaine
      • Rennes, Ille-et-Vilaine, France, 35000
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 99 28 42 70
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Recruiting
        • Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 02 41 35 36 37
    • Rhone-Alpes
      • Lyon, Rhone-Alpes, France, 69008
        • Recruiting
        • CENTRE LEON BERARD-Medical oncology ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: + 33 4 26 55 67 59
  • Germany
      • Berlin, Germany, 13125
        • Recruiting
        • Helios Klinikum Berlin-Buch ( Site 1011)
        • Contact:
          • Study Coordinator
          • Phone Number: 4930940154801
      • Berlin, Germany, 10117
        • Recruiting
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)
        • Contact:
          • Study Coordinator
          • Phone Number: +49-(0)30-450 615092
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 (0) 40 7410-57118
    • Baden-Wurttemberg
      • Singen, Baden-Wurttemberg, Germany, 78224
        • Recruiting
        • Hegau-Bodensee-Klinikum Singen ( Site 1016)
        • Contact:
          • Study Coordinator
          • Phone Number: 07731892900
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Universitaetsklinikum Tuebingen ( Site 1002)
        • Contact:
          • Study Coordinator
          • Phone Number: 4970712987235
    • Bayern
      • Munich, Bayern, Germany, 81675
        • Recruiting
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Sit
        • Contact:
          • Study Coordinator
          • Phone Number: 498941402576
    • Nordrhein-Westfalen
      • Aachen, Nordrhein-Westfalen, Germany, 52074
        • Recruiting
        • Universitätsklinikum Aachen ( Site 1024)
        • Contact:
          • Study Coordinator
          • Phone Number: 0049241800
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Recruiting
        • Universitätsklinikum Bonn ( Site 1006)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 228 287 16202
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Completed
        • Universitaetsklinikum Duesseldorf ( Site 1017)
      • Essen, Nordrhein-Westfalen, Germany, 45147
        • Recruiting
        • Universitaetsklinikum Essen ( Site 1004)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 201 723 3213
      • Münster, Nordrhein-Westfalen, Germany, 48149
        • Recruiting
        • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 (0) 251 8347446
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Completed
        • Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 351 458 4425
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Completed
        • Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie (
    • Thuringen
      • Gera, Thuringen, Germany, 07548
        • Recruiting
        • SRH Wald-Klinikum Gera ( Site 1015)
        • Contact:
          • Study Coordinator
          • Phone Number: +49-(0)365 828 - 7151
      • Jena, Thuringen, Germany, 07747
        • Recruiting
        • Universitätsklinikum Jena ( Site 1007)
        • Contact:
          • Study Coordinator
          • Phone Number: +49 3641 9 32 9947
  • Greece
      • Thessaloniki, Greece, 57001
        • Completed
        • European Interbalkan Medical Center-Oncology Department ( Site 1105)
      • Thessaloniki, Greece, 546 45
        • Completed
        • Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)
    • Attiki
      • Athens, Attiki, Greece, 115 28
        • Recruiting
        • Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: 0302132162513
      • Athens, Attiki, Greece, 185 47
        • Recruiting
        • Metropolitan Hospital-2nd Oncology Dept ( Site 1104)
        • Contact:
          • Study Coordinator
          • Phone Number: +302104809150
      • Chaidari, Attiki, Greece, 124 62
        • Recruiting
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)
        • Contact:
          • Study Coordinator
          • Phone Number: +302105831255
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)
        • Contact:
          • Study Coordinator
          • Phone Number: 3652255840
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)
        • Contact:
          • Study Coordinator
          • Phone Number: +3662545405
    • Gyor-Moson-Sopron
      • Gyor, Gyor-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)
        • Contact:
          • Study Coordinator
          • Phone Number: +36704511995
    • Pest
      • Budapest, Pest, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)
        • Contact:
          • Study Coordinator
          • Phone Number: 3612248600
    • Somogy
      • Kaposvár, Somogy, Hungary, 7400
        • Recruiting
        • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)
        • Contact:
          • Study Coordinator
          • Phone Number: +36304111268
  • Ireland
      • Cork, Ireland, T12 E8YV
        • Recruiting
        • Cork University Hospital ( Site 1404)
        • Contact:
          • Study Coordinator
          • Phone Number: 0214922843
      • Dublin, Ireland, Dublin 9
        • Recruiting
        • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)
        • Contact:
          • Study Coordinator
          • Phone Number: 0876130775
    • Dublin
      • Dublin 24, Dublin, Ireland, D24 NR0A
        • Recruiting
        • Tallaght University Hospital ( Site 1402)
        • Contact:
          • Study Coordinator
          • Phone Number: 35314144208
      • Dublin 4, Dublin, Ireland
        • Recruiting
        • St. Vincent's University Hospital ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: 35314144208
  • Israel
      • Be'er Sheva, Israel, 8410101
        • Recruiting
        • Soroka Medical Center ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 972523514527
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 4 7776750
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center-Oncology ( Site 1506)
        • Contact:
          • Study Coordinator
          • Phone Number: 972505172315
      • Petah-Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Oncology ( Site 1503)
        • Contact:
          • Study Coordinator
          • Phone Number: 97239378003
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center-ONCOLOGY ( Site 1504)
        • Contact:
          • Study Coordinator
          • Phone Number: 97235302191
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Sourasky Medical Center-Oncology ( Site 1501)
        • Contact:
          • Study Coordinator
          • Phone Number: + 972 972 3 6947284
  • Italy
      • Arezzo, Italy, 52100
        • Recruiting
        • Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)
        • Contact:
          • Study Coordinator
          • Phone Number: 390575255446
      • Bologna, Italy, 40138
        • Recruiting
        • IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: +39 0512142575
      • Terni, Italy, 05100
        • Recruiting
        • Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: 390744205410
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Recruiting
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)
        • Contact:
          • Study Coordinator
          • Phone Number: 0543739426
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)
        • Contact:
          • Study Coordinator
          • Phone Number: +390630154953
    • Lombardia
      • Milan, Lombardia, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)
        • Contact:
          • Study Coordinator
          • Phone Number: 00390223904450
      • Milano, Lombardia, Italy, 20132
        • Recruiting
        • Ospedale San Raffaele-Oncologia Medica ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: +390226435789
    • Piemonte
      • Orbassano, Piemonte, Italy, 10043
        • Recruiting
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)
        • Contact:
          • Study Coordinator
          • Phone Number: 390119026993
    • Puglia
      • Bari, Puglia, Italy, 70124
        • Recruiting
        • A.O.U.C. Policlinico di Bari ( Site 1607)
        • Contact:
          • Study Coordinator
          • Phone Number: +390805594167
    • Toscana
      • Firenze, Toscana, Italy, 50134
        • Recruiting
        • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 0557947298
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • Kyushu University Hospital ( Site 1715)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-92-641-1151
      • Kagoshima, Japan, 890-8520
        • Active, not recruiting
        • Kagoshima University Hospital ( Site 1719)
      • Kumamoto, Japan, 860-8556
        • Recruiting
        • Kumamoto University ( Site 1716)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-96-344-2111
      • Okayama, Japan, 700-8558
        • Active, not recruiting
        • Okayama University Hospital ( Site 1720)
      • Tokyo, Japan, 113-8603
        • Recruiting
        • Nippon Medical School Hospital ( Site 1705)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3822-2131
      • Tokyo, Japan, 160-8582
        • Recruiting
        • Keio university hospital ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3353-1211
      • Tokyo, Japan, 123-8558
        • Active, not recruiting
        • Tokyo Women's Medical University Adachi Medical Center ( Site 1717)
      • Wakayama, Japan, 641-8510
        • Active, not recruiting
        • Wakayama Medical University Hospital ( Site 1721)
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Active, not recruiting
        • Fujita Health University ( Site 1709)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
      • Sakura, Chiba, Japan, 285-8741
        • Active, not recruiting
        • Toho University Sakura Medical Center ( Site 1718)
    • Ehime
      • Toon, Ehime, Japan, 791-0295
        • Recruiting
        • Ehime University Hospital ( Site 1714)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-89-964-5111
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Active, not recruiting
        • Sapporo Medical University Hospital ( Site 1702)
      • Sapporo, Hokkaido, Japan, 060-8648
        • Active, not recruiting
        • Hokkaido University Hospital ( Site 1701)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Active, not recruiting
        • Kanagawa cancer center ( Site 1703)
    • Nara
      • Kashihara, Nara, Japan, 634-0813
        • Recruiting
        • Nara Medical University Hospital ( Site 1712)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-744-22-3051
    • Osaka
      • Sakai, Osaka, Japan, 599-8247
        • Active, not recruiting
        • Bell Land General Hospital ( Site 1710)
      • Suita, Osaka, Japan, 565-0871
        • Active, not recruiting
        • Osaka University Hospital ( Site 1711)
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Recruiting
        • Hamamatsu University Hospital ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-53-435-2111
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8470
        • Recruiting
        • Toranomon Hospital ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-3-3588-1111
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Completed
        • Toyama University Hospital ( Site 1713)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 2603)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 1599-3114
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, Korea, Republic of, 10408
        • Recruiting
        • National Cancer Center-Center for Urologic Cancer ( Site 2604)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 31-920-0114
      • Seongnam, Kyonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital-Urology ( Site 2602)
        • Contact:
          • Study Coordinator
          • Phone Number: 82317877342
    • Seoul
      • Songpagu, Seoul, Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center-Oncology ( Site 2601)
        • Contact:
          • Study Coordinator
          • Phone Number: 82230105977
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • Recruiting
        • University Malaya Medical Centre ( Site 1804)
        • Contact:
          • Study Coordinator
          • Phone Number: +60378414000
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Recruiting
        • Hospital Pulau Pinang ( Site 1806)
        • Contact:
          • Study Coordinator
          • Phone Number: +6042225768
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Recruiting
        • Sarawak General Hospital-Radiotherapy Unit ( Site 1805)
        • Contact:
          • Study Coordinator
          • Phone Number: +6082276666 ext 6030
  • Mexico
      • Oaxaca, Mexico, 68020
        • Recruiting
        • Centro de Investigacion Clinica de Oaxaca ( Site 1904)
        • Contact:
          • Study Coordinator
          • Phone Number: +529516035559
      • Puebla, Mexico, 72530
        • Active, not recruiting
        • Oncocenter ( Site 1909)
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1
        • Contact:
          • Study Coordinator
          • Phone Number: 5215554386271
      • Mexico City, Distrito Federal, Mexico, 14070
        • Completed
        • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44260
        • Recruiting
        • Terapias Integrales del Riñon SA de CV ( Site 1910)
        • Contact:
          • Study Coordinator
          • Phone Number: +523318414819
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 3322648799
      • Guadalajara, Jalisco, Mexico
        • Recruiting
        • BRCR Global Mexico - Guadalajara-Research ( Site 1908)
        • Contact:
          • Study Coordinator
          • Phone Number: +523316546308
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Active, not recruiting
        • Filios Alta Medicina ( Site 1903)
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Active, not recruiting
        • iCan Oncology Center Centro Medico AVE ( Site 1901)
    • Queretaro
      • Santiago de Queretaro, Queretaro, Mexico, 76000
        • Recruiting
        • Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 4422428555
      • Santiago de Querétaro, Queretaro, Mexico, 76070
        • Recruiting
        • BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)
        • Contact:
          • Study Coordinator
          • Phone Number: +52 442 195 9392
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80040
        • Active, not recruiting
        • Centro de Oncología Personalizada ( Site 1911)
  • Netherlands
      • Groningen, Netherlands, 9700RB
        • Recruiting
        • University Medical Center Groningen ( Site 3121)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 503 612 821
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)
        • Contact:
          • Study Coordinator
          • Phone Number: 31887556308
      • Utrecht, Netherlands, 3543 AZ
        • Completed
        • St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Recruiting
        • Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)
        • Contact:
          • Study Coordinator
          • Phone Number: +31880057526
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 3120)
        • Contact:
          • Study Coordinator
          • Phone Number: +31 24 361 1111
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Recruiting
        • Maastricht UMC+ ( Site 3104)
        • Contact:
          • Study Coordinator
          • Phone Number: 0031433876543
    • Noord-Brabant
      • Breda, Noord-Brabant, Netherlands, 4818 CK
        • Recruiting
        • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)
        • Contact:
          • Study Coordinator
          • Phone Number: +3176595 5000
      • Eindhoven, Noord-Brabant, Netherlands, 5600 PD
        • Completed
        • Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Recruiting
        • Amsterdam UMC, locatie AMC ( Site 3105)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 444 4444
      • Hilversum, Noord-Holland, Netherlands, 1213 XZ
        • Recruiting
        • Tergooiziekenhuizen, locatie Hilversum ( Site 3102)
        • Contact:
          • Study Coordinator
          • Phone Number: +31887535153
      • Hoofddorp, Noord-Holland, Netherlands, 2134 TM
        • Recruiting
        • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)
        • Contact:
          • Study Coordinator
          • Phone Number: +31232240000
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Recruiting
        • Isala, locatie Zwolle-Oncology ( Site 3111)
        • Contact:
          • Study Coordinator
          • Phone Number: 088 624 5000
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • Recruiting
        • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)
        • Contact:
          • Study Coordinator
          • Phone Number: +31702104088
      • Leidschendam, Zuid-Holland, Netherlands, 2501 ck
        • Recruiting
        • Haaglanden MC - locatie Antoniushove ( Site 3117)
        • Contact:
          • Study Coordinator
          • Phone Number: 088 979 79 00
      • Schiedam, Zuid-Holland, Netherlands, 3118 JH
        • Recruiting
        • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)
        • Contact:
          • Study Coordinator
          • Phone Number: +31104612692
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Auckland City Hospital-Cancer & Blood Research ( Site 2003)
        • Contact:
          • Study Coordinator
          • Phone Number: 6493074949
  • Poland
    • Dolnoslaskie
      • Wrocław, Dolnoslaskie, Poland, 50-556
        • Recruiting
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)
        • Contact:
          • Study Coordinator
          • Phone Number: 48601143281
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Recruiting
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)
        • Contact:
          • Study Coordinator
          • Phone Number: 48501446778
      • Torun, Kujawsko-pomorskie, Poland, 87-100
        • Recruiting
        • MICS Centrum Medyczne Torun ( Site 2305)
        • Contact:
          • Study Coordinator
          • Phone Number: +48606184840
    • Malopolskie
      • Tarnow, Malopolskie, Poland, 33-100
        • Recruiting
        • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)
        • Contact:
          • Study Coordinator
          • Phone Number: 48602280826
    • Mazowieckie
      • Siedlce, Mazowieckie, Poland, 08-110
        • Recruiting
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)
        • Contact:
          • Study Coordinator
          • Phone Number: 48698826497
      • Warszawa, Mazowieckie, Poland, 02-781
        • Recruiting
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
        • Contact:
          • Study Coordinator
          • Phone Number: 48225462331
      • Warszawa, Mazowieckie, Poland, 01-748
        • Recruiting
        • Luxmed Onkologia sp. z o. o. ( Site 2303)
        • Contact:
          • Study Coordinator
          • Phone Number: 48691666578
    • Podkarpackie
      • Przemysl, Podkarpackie, Poland, 37-700
        • Recruiting
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)
        • Contact:
          • Study Coordinator
          • Phone Number: 661957237
    • Wielkopolskie
      • Konin, Wielkopolskie, Poland, 62-500
        • Active, not recruiting
        • Przychodnia Lekarska KOMED ( Site 2304)
      • Poznań, Wielkopolskie, Poland, 60-569
        • Recruiting
        • Szpital Kliniczny im. Przemienienia Panskiego Uniwersytetu M-chemotherapy department ( Site 2312)
        • Contact:
          • Study Coordinator
          • Phone Number: 48601569568
    • Zachodniopomorskie
      • Koszalin, Zachodniopomorskie, Poland, 75-581
        • Recruiting
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)
        • Contact:
          • Study Coordinator
          • Phone Number: +48502204953
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)
        • Contact:
          • Study Coordinator
          • Phone Number: +48608430889
  • Romania
    • Bucuresti
      • București, Bucuresti, Romania, 022548
        • Recruiting
        • Centrul medical Focus ( Site 2407)
        • Contact:
          • Study Coordinator
          • Phone Number: +40721298677
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 2406)
        • Contact:
          • Study Coordinator
          • Phone Number: +40721254415
      • Florești, Cluj, Romania, 407280
        • Recruiting
        • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)
        • Contact:
          • Study Coordinator
          • Phone Number: +40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Recruiting
        • Centrul de Oncologie "Sfântul Nectarie"-Medical Oncology ( Site 2401)
        • Contact:
          • Study Coordinator
          • Phone Number: +40727774974
    • Ilfov
      • Otopeni, Ilfov, Romania, 075100
        • Recruiting
        • Radiology Therapeutic Center-Oncology ( Site 2404)
        • Contact:
          • Study Coordinator
          • Phone Number: +40372693561
    • Timis
      • Timișoara, Timis, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 2403)
        • Contact:
          • Study Coordinator
          • Phone Number: +40745100495
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • Recruiting
        • National Cancer Centre Singapore ( Site 3601)
        • Contact:
          • Study Coordinator
          • Phone Number: +6564368000
    • South West
      • Singapore, South West, Singapore, 119074
        • Recruiting
        • National University Hospital ( Site 3602)
        • Contact:
          • Study Coordinator
          • Phone Number: +6567722527
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934894350
      • Lugo, Spain, 27003
        • Recruiting
        • Hospital Lucus Augusti-Oncology ( Site 2706)
        • Contact:
          • Study Coordinator
          • Phone Number: +34982296459
      • Madrid, Spain, 28040
        • Recruiting
        • Hospital Clinico San Carlos-Oncology Department ( Site 2703)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913303000 x3133
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)
        • Contact:
          • Study Coordinator
          • Phone Number: +34951032508
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Recruiting
        • Institut Català d'Oncologia (ICO) - Girona ( Site 2707)
        • Contact:
          • Study Coordinator
          • Phone Number: +34972225828
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
      • Madrid, Madrid, Comunidad De, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913908339
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Recruiting
        • Fundación Instituto Valenciano de Oncología ( Site 2705)
        • Contact:
          • Study Coordinator
          • Phone Number: +34961104605
  • Sweden
    • Stockholms Lan
      • Stockholm, Stockholms Lan, Sweden, 171 76
        • Recruiting
        • Karolinska Universitetssjukhuset Solna ( Site 2802)
        • Contact:
          • Study Coordinator
          • Phone Number: +46851770000
    • Uppsala Lan
      • Uppsala, Uppsala Lan, Sweden, 751 85
        • Recruiting
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 46186110000
    • Vastra Gotalands Lan
      • Gothenburg, Vastra Gotalands Lan, Sweden, 413 45
        • Completed
        • Sahlgrenska Universitetssjukhuset ( Site 2801)
  • Taiwan
      • Kaohsiung, Taiwan, 81362
        • Recruiting
        • Kaohsiung Veterans General Hospital ( Site 2901)
        • Contact:
          • Study Coordinator
          • Phone Number: +886-7-3422121
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital-Department of Urology ( Site 2907)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-4-22052121 ext. 4440
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 2902)
        • Contact:
          • Study Coordinator
          • Phone Number: +886423592525 ext.5121
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 2903)
        • Contact:
          • Study Coordinator
          • Phone Number: 886228757519x315
      • Taipei, Taiwan, 100225
        • Recruiting
        • National Taiwan University Hospital ( Site 2904)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-23123456
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-975366241
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-28757519 ext. 315
    • Taipei
      • Taipei City, Taipei, Taiwan, 114
        • Recruiting
        • Tri-Service General Hospital ( Site 2908)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-87923311 ext. 13480
  • Thailand
    • Krung Thep Maha Nakhon
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10330
        • Recruiting
        • Chulalongkorn University ( Site 3005)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622564533
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10400
        • Recruiting
        • Ramathibodi Hospital ( Site 3001)
        • Contact:
          • Study Coordinator
          • Phone Number: +6622011671
      • Bangkok, Krung Thep Maha Nakhon, Thailand, 10700
        • Recruiting
        • Faculty of Medicine Siriraj Hospital ( Site 3002)
        • Contact:
          • Study Coordinator
          • Phone Number: +6624194488
    • Songkhla
      • Hatyai, Songkhla, Thailand, 90110
        • Recruiting
        • Songklanagarind hospital ( Site 3004)
        • Contact:
          • Study Coordinator
          • Phone Number: +6674451469
  • Turkey
      • Adana, Turkey, 01250
        • Recruiting
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)
        • Contact:
          • Study Coordinator
          • Phone Number: 905325005269
      • Ankara, Turkey, 06010
        • Recruiting
        • Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)
        • Contact:
          • Study Coordinator
          • Phone Number: +905366401020
      • Ankara, Turkey, 06100
        • Recruiting
        • Ankara University Hospital Cebeci ( Site 3209)
        • Contact:
          • Study Coordinator
          • Phone Number: +905337483275
      • Ankara, Turkey, 06230
        • Recruiting
        • Hacettepe Universitesi-oncology hospital ( Site 3203)
        • Contact:
          • Study Coordinator
          • Phone Number: +905334318506
      • Istanbul, Turkey, 34722
        • Recruiting
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)
        • Contact:
          • Study Coordinator
          • Phone Number: 905063509061
      • Izmir, Turkey, 35100
        • Recruiting
        • Ege University Medicine of Faculty-Medical Oncology ( Site 3202)
        • Contact:
          • Study Coordinator
          • Phone Number: +905324510608
    • Ankara
      • Yenimahalle, Ankara, Turkey, 06200
        • Recruiting
        • Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)
        • Contact:
          • Study Coordinator
          • Phone Number: +905555306271
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey, 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)
        • Contact:
          • Study Coordinator
          • Phone Number: +902124400000
  • United Kingdom
    • England
      • London, England, United Kingdom, NW32QG
        • Recruiting
        • Royal Free Hospital ( Site 3304)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7822 8498
      • Manchester, England, United Kingdom, M20 4BX
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 3301)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 161 918 7217
      • Nottingham, England, United Kingdom, NG5 1PF
        • Recruiting
        • City Hospital, Nottingham University Hospitals ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: 441158231851
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)
        • Contact:
          • Study Coordinator
          • Phone Number: +44 141 3017064
    • Hammersmith And Fulham
      • London, Hammersmith And Fulham, United Kingdom, W6 8RF
        • Recruiting
        • Charing Cross Hospital ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: 442033110277
    • London, City Of
      • London, London, City Of, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)
        • Contact:
          • Study Coordinator
          • Phone Number: 020 7822 8498
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • Recruiting
        • Singleton Hospital ( Site 3306)
        • Contact:
          • Study Coordinator
          • Phone Number: 01792285520
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Completed
        • Mayo Clinic in Arizona - Phoenix ( Site 3554)
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center ( Site 3567)
        • Contact:
          • Study Coordinator
          • Phone Number: 626256467389200
      • La Jolla, California, United States, 92093
        • Recruiting
        • Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)
        • Contact:
          • Study Coordinator
          • Phone Number: 719-304-1132
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro
        • Contact:
          • Study Coordinator
          • Phone Number: 310-794-7700
      • Orange, California, United States, 92868
        • Recruiting
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)
        • Contact:
          • Study Coordinator
          • Phone Number: 714-456-5153
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford Cancer Center ( Site 3523)
        • Contact:
          • Study Coordinator
          • Phone Number: 650-725-2078
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 3514)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-3427
      • Grand Junction, Colorado, United States, 81501
        • Recruiting
        • St. Marys Hospital and Regional Medical Center-SCL Health Cancer Centers of Colorado ( Site 3562)
        • Contact:
          • Study Coordinator
          • Phone Number: 970-298-7500
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Completed
        • Georgetown University Medical Center ( Site 3534)
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 35
        • Contact:
          • Study Coordinator
          • Phone Number: 954-243-1000
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center ( Site 3540)
        • Contact:
          • Study Coordinator
          • Phone Number: 281-520-5143
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-281-5101
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Recruiting
        • Parkview Research Center at Parkview Regional Medical Center ( Site 3526)
        • Contact:
          • Study Coordinator
          • Phone Number: 260-425-6800
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Recruiting
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-570-9410
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute-GU ( Site 3505)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-5456
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital ( Site 3571)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-726-1594
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-632-9250
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan ( Site 3502)
        • Contact:
          • Study Coordinator
          • Phone Number: 269-993-6056
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University-Internal Medicine/Oncology ( Site 3531)
        • Contact:
          • Study Coordinator
          • Phone Number: 314-362-5740
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center-Research ( Site 3506)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-238-6290
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-334-4773
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital and Medical Center ( Site 3557)
        • Contact:
          • Study Coordinator
          • Phone Number: 201-568-5250
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey ( Site 3541)
        • Contact:
          • Study Coordinator
          • Phone Number: 732-235-2465
    • New York
      • Lake Success, New York, United States, 11042
        • Completed
        • Monter Cancer Center ( Site 3560)
      • New York, New York, United States, 10029
        • Recruiting
        • Icahn School of Medicine at Mount Sinai ( Site 3539)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-824-8782
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center ( Site 3568)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-422-4312
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester Medical Center ( Site 3528)
        • Contact:
          • Study Coordinator
          • Phone Number: 585-275-9319
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
        • Contact:
          • Study Coordinator
          • Phone Number: 614-293-1870
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • Recruiting
        • MidLantic urology ( Site 3501)
        • Contact:
          • Study Coordinator
          • Phone Number: 610-667-0458
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center-GU Oncology ( Site 3535)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-728-4300
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Completed
        • Sanford Cancer Center ( Site 3551)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • The West Clinic, PLLC dba West Cancer Center ( Site 3522)
        • Contact:
          • Study Coordinator
          • Phone Number: 901-683-0055
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates ( Site 3512)
        • Contact:
          • Study Coordinator
          • Phone Number: 615-250-9200
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center ( Site 3529)
        • Contact:
          • Study Coordinator
          • Phone Number: 301-512-7242
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center-Urology ( Site 3569)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-3250
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Completed
        • Inova Schar Cancer Institute ( Site 3525)
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)
        • Contact:
          • Study Coordinator
          • Phone Number: 425-830-1098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Belzutifan + Pembrolizumab
Participants receive belzutifan 120 mg orally once daily (QD) for up to approximately 54 weeks PLUS pembrolizumab 400 mg via intravenous (IV) infusion once every 6 weeks (Q6W) for up to 9 administrations (up to approximately 54 weeks).
Drug: Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Other Names:
  • MK-6482
  • PT2977
  • WELIREG™
Biological: Pembrolizumab
400 mg via IV infusion
Other Names:
  • MK-3475
  • Keytruda®
Experimental: Placebo + Pembrolizumab
Participants receive placebo orally QD for up to approximately 54 weeks PLUS pembrolizumab 400 mg via IV infusion once Q6W for up to 9 administrations (up to approximately 54 weeks).
Drug: Placebo
Oral tablet
Biological: Pembrolizumab
400 mg via IV infusion
Other Names:
  • MK-3475
  • Keytruda®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS)
Time Frame: Up to approximately 54 months
DFS is defined as the time from randomization to the first documented local recurrence, or occurrence of distant kidney cancer metastasis(es) as assessed by investigator, or death due to any cause, whichever occurs first. The DFS for all participants will be presented.
Up to approximately 54 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 54 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinued the study due to an AE will be reported.
Up to approximately 54 weeks
Overall Survival (OS)
Time Frame: Up to approximately 89 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 89 months
Number of Participants Who Experience at Least One Adverse Event (AE)
Time Frame: Up to approximately 66 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experienced an AE will be reported.
Up to approximately 66 weeks
Disease Recurrence-Specific Survival 1 (DRSS1)
Time Frame: Up to approximately 54 months
DRSS1 is defined as the time from randomization to the first documented local recurrence of RCC as assessed by the investigator. For DRSS1, only local recurrence is counted as an event.
Up to approximately 54 months
Disease Recurrence-Specific Survival 2 (DRSS2)
Time Frame: Up to approximately 54 months
DRSS2 is defined as the time from randomization to the first documented local recurrence with visceral lesion or occurrence of distant kidney cancer metastasis(es) with visceral lesion, whichever occurs first, as assessed by investigator.
Up to approximately 54 months
Change From Baseline in Physical Functioning Using the EORTC QLQ-C30 Items 1- 5 Score
Time Frame: Baseline (Day 1) and up to approximately 36 months
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher scores indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 1-5 will be presented.
Baseline (Day 1) and up to approximately 36 months
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
Time Frame: Baseline (Day 1) and up to approximately 36 months
The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status. Change from baseline in the score of FKSI-DRS Items 1-9 will be presented.
Baseline (Day 1) and up to approximately 36 months
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
Time Frame: Baseline (Day 1) and up to approximately 36 months
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of participants with cancer. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined scores will be presented.
Baseline (Day 1) and up to approximately 36 months
Change From Baseline in Role Functioning Using the EORTC QLQ-C30 Items 6 and 7 Score
Time Frame: Baseline (Day 1) and up to approximately 36 months
The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Higher score indicate a worse level of function. Change from baseline in the score of EORTC QLQ-C30 Items 6-7 will be presented.
Baseline (Day 1) and up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2022

Primary Completion (Estimated)

October 28, 2026

Study Completion (Estimated)

September 28, 2029

Study Registration Dates

First Submitted

February 4, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (Actual)

February 15, 2022

Study Record Updates

Last Update Posted (Estimated)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6482-022
  • MK-6482-022 (Other Identifier: Merck)
  • LITESPARK-022 (Other Identifier: Merck)
  • jRCT2051220030 (Registry Identifier: jRCT)
  • 2021-003436-92 (EudraCT Number)
  • 2023-505023-31 (Other Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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