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)

May 14, 2026 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

Active, not 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 Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Blacktown Hospital ( Site 0002)
      • Macquarie University, New South Wales, Australia, 2109
        • Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)
      • North Tamworth, New South Wales, Australia, 2340
        • Tamworth Hospital-North West Cancer Centre ( Site 0006)
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
        • Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health-Cancer Clinical Trials Centre ( Site 0005)
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Fiona Stanley Hospital-Medical Oncology ( Site 0004)
  • Brazil
      • São Paulo, Brazil, 01321-001
        • BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)
    • Ceará
      • Fortaleza, Ceará, Brazil, 60135-237
        • Hospital São Carlos-Oncocentro Ce ( Site 0104)
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30130090
        • Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)
    • Paraná
      • Curitiba, Paraná, Brazil, 80510-130
        • Instituto do Câncer e Transplante de Curitiba ( Site 0102)
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59075-740
        • Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 91350-200
        • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)
    • São Paulo
      • Ribeirão Preto, São Paulo, Brazil, 14048900
        • Hospital de Clínicas de Ribeirão Preto ( Site 0112)
  • Bulgaria
      • Plovdiv, Bulgaria, 4004
        • Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)
    • Pazardzhik
      • Panagyurishte, Pazardzhik, Bulgaria, 4500
        • MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)
    • Sofia (stolitsa)
      • Sofia, Sofia (stolitsa), Bulgaria, 1301
        • MHAT Serdika-Second Department of Medical Oncology ( Site 0203)
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 5G2
        • Arthur J.E. Child Comprehensive Cancer Centre ( Site 3706)
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre ( Site 3705)
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre ( Site 3703)
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)
      • Montreal, Quebec, Canada, H4A 3J1
        • McGill University Health Centre ( Site 3709)
      • Québec, Quebec, Canada, G1J 1Z4
        • Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3701)
  • Chile
      • Antofagasta, Chile, 1240000
        • Bradford Hill Norte ( Site 0303)
    • Araucania
      • Temuco, Araucania, Chile, 4800827
        • James Lind Centro de Investigacion del Cancer ( Site 0307)
    • Los Lagos Region
      • Port Montt, Los Lagos Region, Chile, 5500243
        • Clínica Puerto Montt ( Site 0309)
    • Los Ríos Region
      • Valdivia, Los Ríos Region, Chile, 5112129
        • Oncocentro Valdivia ( Site 0312)
    • Region M. de Santiago
      • Santiago, Region M. de Santiago, Chile, 7500921
        • FALP-UIDO ( Site 0302)
      • Santiago, Region M. de Santiago, Chile, 7500994
        • Oncovida ( Site 0306)
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Bradfordhill ( Site 0305)
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520598
        • ONCOCENTRO APYS-ACEREY ( Site 0301)
  • China
    • Anhui
      • Bengbu, Anhui, China, 233004
        • The First Affiliated Hospital of Bengbu Medical University- Urology Surgery ( Site 0438)
      • Hefei, Anhui, China, 230000
        • The Second Hospital Of Anhui Medical University ( Site 0416)
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100021
        • Cancer Hospital Chinese Academy of Medical Sciences ( Site 0435)
      • Beijing, Beijing Municipality, China, 100142
        • Beijing Cancer hospital-Urinary Surgery ( Site 0406)
      • Beijing, Beijing Municipality, China, 100853
        • First Medical Center of Chinese PLA General Hospital ( Site 0415)
      • Beijing, Beijing Municipality, China, 102627
        • Peking University First Hospital-Urology ( Site 0407)
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400030
        • Chongqing University Cancer Hospital ( Site 0414)
      • Chongqing, Chongqing Municipality, China, 400042
        • Army Medical Center of People's Liberation Army ( Site 0439)
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital of Fujian Medical University ( Site 0445)
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 0402)
      • Guangzhou, Guangdong, China, 510060
        • Sun Yat-Sen University Cancer Center ( Site 0417)
      • Guangzhou, Guangdong, China, 510120
        • The First Affiliated Hospital of Guangzhou Medical University ( Site 0403)
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Henan Cancer Hospital-Urology ( Site 0441)
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Hubei Cancer Hospital-Urinary surgery ( Site 0419)
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0430)
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical College of HUST ( Site 0423)
    • Hunan
      • Changsha, Hunan, China, 410006
        • Hunan Cancer Hospital ( Site 0421)
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0424)
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The Second Affiliated Hospital of Nanchang University ( Site 0443)
      • Nanchang, Jiangxi, China, 330209
        • The First Affiliated Hospital of Nanchang University ( Site 0432)
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200001
        • Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)
      • Shanghai, Shanghai Municipality, China, 200040
        • Huadong Hospital ( Site 0405)
      • Shanghai, Shanghai Municipality, China, 200120
        • Fudan University Shanghai Cancer Center ( Site 0401)
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital of Sichuan University-Urology Surgery ( Site 0410)
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Tianjin Medical University Cancer Institute and Hospital ( Site 0422)
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0428)
      • Hangzhou, Zhejiang, China, 310014
        • Zhejiang Provincial People's Hospital ( Site 0426)
      • Ningbo, Zhejiang, China, 315010
        • The First Affiliated Hospital of Ningbo University ( Site 0433)
      • Wenzhou, Zhejiang, China, 325000
        • The First Affiliated Hospital of Wenzhou Medical University ( Site 0425)
  • Colombia
    • Atlántico
      • Barranquilla, Atlántico, Colombia, 080020
        • Clinica de la Costa S.A.S. ( Site 0506)
    • Bogota D.C.
      • Bogotá, Bogota D.C., Colombia, 110221
        • Administradora Country S.A. - Clinica del Country ( Site 0504)
    • Cesar Department
      • Valledupar, Cesar Department, Colombia, 200001
        • Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)
    • Departamento de Córdoba
      • Montería, Departamento de Córdoba, Colombia, 230002
        • IMAT S.A.S ( Site 0501)
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)
    • Brno-mesto
      • Brno, Brno-mesto, Czechia, 656 53
        • Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)
      • Brno, Brno-mesto, Czechia, 602 00
        • Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)
    • Olomouc Region
      • Olomouc, Olomouc Region, Czechia, 779 00
        • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)
    • Praha 4
      • Prague, Praha 4, Czechia, 140 59
        • Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)
    • Praha 5
      • Prague, Praha 5, Czechia, 150 06
        • Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)
  • Finland
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90220
        • Oulun yliopistollinen sairaala ( Site 0802)
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala ( Site 0805)
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Turku University Hospital ( Site 0801)
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)
  • France
      • Paris, France, 75010
        • Hôpital Saint-Louis ( Site 0905)
      • Paris, France, 75015
        • Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69373 Cedex 08
        • CENTRE LEON BERARD-Medical oncology ( Site 0902)
    • Bas-Rhin
      • Strasbourg, Bas-Rhin, France, 67200
        • Hopitaux Universitaires de Strasbourg ( Site 0903)
    • Brittany Region
      • Rennes, Brittany Region, France, 35000
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)
    • Centre-Val de Loire
      • Chambray-lès-Tours, Centre-Val de Loire, France, 37170
        • ROC37 ( Site 0910)
    • Doubs
      • Besançon, Doubs, France, 25000
        • CHU Besançon-Medical oncology ( Site 0904)
    • Maine-et-Loire
      • Angers, Maine-et-Loire, France, 49933
        • Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Gustave Roussy ( Site 0907)
  • Germany
      • Berlin, Germany, 10117
        • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)
      • Berlin, Germany, 13125
        • Helios Klinikum Berlin-Buch ( Site 1011)
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)
    • Baden-Wurttemberg
      • Singen, Baden-Wurttemberg, Germany, 78224
        • Hegau-Bodensee-Klinikum Singen ( Site 1016)
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitaetsklinikum Tuebingen ( Site 1002)
    • Bavaria
      • Munich, Bavaria, Germany, 81675
        • klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 1003)
    • North Rhine-Westphalia
      • Aachen, North Rhine-Westphalia, Germany, 52074
        • Universitätsklinikum Aachen ( Site 1024)
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitätsklinikum Bonn ( Site 1006)
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universitaetsklinikum Duesseldorf ( Site 1017)
      • Essen, North Rhine-Westphalia, Germany, 45147
        • Universitaetsklinikum Essen ( Site 1004)
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)
    • Saarland
      • Homburg, Saarland, Germany, 66421
        • Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germany, 06120
        • Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie ( Site 1008)
    • Thuringia
      • Gera, Thuringia, Germany, 07548
        • SRH Wald-Klinikum Gera ( Site 1015)
      • Jena, Thuringia, Germany, 07747
        • Universitätsklinikum Jena ( Site 1007)
  • Greece
      • Thessaloniki, Greece, 546 45
        • Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)
      • Thessaloniki, Greece, 570 01
        • European Interbalkan Medical Center-Oncology Department ( Site 1105)
    • Attica
      • Athens, Attica, Greece, 115 28
        • Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)
      • Athens, Attica, Greece, 185 47
        • Metropolitan Hospital-2nd Oncology Dept ( Site 1104)
      • Chaïdári, Attica, Greece, 124 62
        • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)
  • Hungary
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)
    • Csongrád megye
      • Szeged, Csongrád megye, Hungary, 6725
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)
    • Pest County
      • Budapest, Pest County, Hungary, 1122
        • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)
    • Somogy County
      • Kaposvár, Somogy County, Hungary, 7400
        • Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)
  • Ireland
      • Cork, Ireland, T12 E8YV
        • Cork University Hospital ( Site 1404)
      • Dublin, Ireland, Dublin 9
        • Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)
    • Dublin
      • Dublin, Dublin, Ireland, D04 T6F4
        • St. Vincent's University Hospital ( Site 1401)
      • Dublin, Dublin, Ireland, D24 NR0A
        • Tallaght University Hospital ( Site 1402)
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center ( Site 1505)
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus-Oncology ( Site 1502)
      • Jerusalem, Israel, 9112001
        • Hadassah Medical Center-Oncology ( Site 1506)
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center-Oncology ( Site 1503)
      • Ramat Gan, Israel, 5265601
        • Sheba Medical Center-ONCOLOGY ( Site 1504)
      • Tel Aviv, Israel, 6423906
        • Sourasky Medical Center-Oncology ( Site 1501)
  • Italy
      • Arezzo, Italy, 52100
        • Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)
      • Bologna, Italy, 40138
        • IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)
      • Milan, Italy, 20132
        • Ospedale San Raffaele-Oncologia Medica ( Site 1606)
      • Terni, Italy, 05100
        • Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)
    • Apulia
      • Bari, Apulia, Italy, 70124
        • A.O.U.C. Policlinico di Bari ( Site 1607)
    • Emilia-Romagna
      • Meldola, Emilia-Romagna, Italy, 47014
        • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)
    • Piedmont
      • Orbassano, Piedmont, Italy, 10043
        • Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)
    • Tuscany
      • Florence, Tuscany, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)
  • Japan
      • Fukuoka, Japan, 812-8582
        • Kyushu University Hospital ( Site 1715)
      • Kagoshima, Japan, 890-8520
        • Kagoshima University Hospital ( Site 1719)
      • Kumamoto, Japan, 860-8556
        • Kumamoto University Hospital ( Site 1716)
      • Okayama, Japan, 700-8558
        • Okayama University Hospital ( Site 1720)
      • Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital ( Site 1705)
      • Tokyo, Japan, 123-8558
        • Tokyo Women's Medical University Adachi Medical Center ( Site 1717)
      • Tokyo, Japan, 160-8582
        • Keio University Hospital ( Site 1707)
      • Wakayama, Japan, 641-8510
        • Wakayama Medical University Hospital ( Site 1721)
    • Aichi-ken
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital ( Site 1709)
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East ( Site 1704)
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center ( Site 1718)
    • Ehime
      • Tōon, Ehime, Japan, 791-0295
        • Ehime University Hospital ( Site 1714)
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8543
        • Sapporo Medical University Hospital ( Site 1702)
      • Sapporo, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital ( Site 1701)
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Kanagawa Cancer Center ( Site 1703)
    • Nara
      • Kashihara, Nara, Japan, 634-0813
        • Nara Medical University Hospital ( Site 1712)
    • Osaka
      • Sakai, Osaka, Japan, 599-8247
        • Bell Land General Hospital ( Site 1710)
      • Suita, Osaka, Japan, 565-0871
        • The University of Osaka Hospital ( Site 1711)
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
        • Hamamatsu University Hospital ( Site 1708)
    • Tokyo
      • Minato-ku, Tokyo, Japan, 105-8470
        • Toranomon Hospital ( Site 1706)
    • Toyama
      • Toyoma, Toyama, Japan, 930-0194
        • Toyama University Hospital ( Site 1713)
  • Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre ( Site 1804)
    • Pulau Pinang
      • George Town, Pulau Pinang, Malaysia, 10450
        • Hospital Pulau Pinang ( Site 1806)
    • Sarawak
      • Kuching, Sarawak, Malaysia, 93586
        • Sarawak General Hospital-Radiotherapy Unit ( Site 1805)
  • Mexico
      • Oaxaca City, Mexico, 68020
        • Centro de Investigacion Clinica de Oaxaca ( Site 1904)
      • Puebla City, Mexico, 72530
        • Oncocenter ( Site 1909)
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44260
        • Terapias Integrales del Riñon SA de CV ( Site 1910)
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)
      • Guadalajara, Jalisco, Mexico
        • BRCR Global Mexico - Guadalajara-Research ( Site 1908)
    • Mexico City
      • Mexico City, Mexico City, Mexico, 14080
        • INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)
      • Mexico City, Mexico City, Mexico, 14080
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1912)
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Filios Alta Medicina ( Site 1903)
      • Monterrey, Nuevo León, Mexico, 64710
        • iCan Oncology Center Centro Medico AVE ( Site 1901)
    • Querétaro
      • Querétaro City, Querétaro, Mexico, 76000
        • Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)
      • Querétaro City, Querétaro, Mexico, 76070
        • BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80040
        • Centro de Oncología Personalizada ( Site 1911)
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • University Medical Center Groningen ( Site 3121)
      • Utrecht, Netherlands, 3543 AZ
        • St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)
      • Utrecht, Netherlands, 3584 CX
        • Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)
    • Gelderland
      • Arnhem, Gelderland, Netherlands, 6815 AD
        • Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Radboudumc ( Site 3120)
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht UMC+ ( Site 3104)
    • North Brabant
      • Breda, North Brabant, Netherlands, 4818 CK
        • Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)
      • Eindhoven, North Brabant, Netherlands, 5600 PD
        • Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, locatie AMC ( Site 3105)
      • Hilversum, North Holland, Netherlands, 1213 XZ
        • Tergooiziekenhuizen, locatie Hilversum ( Site 3102)
      • Hoofddorp, North Holland, Netherlands, 2134 TM
        • Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)
    • Overijssel
      • Zwolle, Overijssel, Netherlands, 8025 AB
        • Isala, locatie Zwolle-Oncology ( Site 3111)
    • South Holland
      • Leidschendam, South Holland, Netherlands, 2501 ck
        • Haaglanden MC - locatie Antoniushove ( Site 3117)
      • Schiedam, South Holland, Netherlands, 3118 JH
        • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)
      • The Hague, South Holland, Netherlands, 2545 AA
        • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital ( Site 2003)
  • Poland
    • Greater Poland Voivodeship
      • Konin, Greater Poland Voivodeship, Poland, 62-500
        • Przychodnia Lekarska KOMED ( Site 2304)
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2312)
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
        • Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • MICS Centrum Medyczne Torun ( Site 2305)
    • Lesser Poland Voivodeship
      • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
        • Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)
      • Warsaw, Masovian Voivodeship, Poland, 01-748
        • Luxmed Onkologia sp. z o. o. ( Site 2303)
      • Warsaw, Masovian Voivodeship, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2301)
    • Podkarpackie Voivodeship
      • Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
        • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)
    • Silesian Voivodeship
      • Wrocław, Silesian Voivodeship, Poland, 50556
        • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)
    • West Pomeranian Voivodeship
      • Koszalin, West Pomeranian Voivodeship, Poland, 75-581
        • Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)
      • Szczecin, West Pomeranian Voivodeship, Poland, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)
  • Romania
      • Bucharest, Romania, 013812
        • MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 2407)
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Cardiomed SRL Cluj-Napoca ( Site 2406)
      • Florești, Cluj, Romania, 407280
        • Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)
    • Dolj
      • Craiova, Dolj, Romania, 200746
        • Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2401)
    • Ilfov
      • Otopeni, Ilfov, Romania, 075100
        • Radiology Therapeutic Center-Oncology ( Site 2404)
    • Timiș County
      • Timișoara, Timiș County, Romania, 300239
        • Cabinet Medical Oncomed ( Site 2403)
  • Singapore
    • Central Singapore
      • Singapore, Central Singapore, Singapore, 168583
        • National Cancer Centre Singapore ( Site 3601)
    • South West
      • Singapore, South West, Singapore, 119074
        • National University Hospital ( Site 3602)
  • South Korea
      • Seoul, South Korea, 06351
        • Samsung Medical Center ( Site 2603)
    • Kyonggi-do
      • Goyang-si, Kyonggi-do, South Korea, 10408
        • National Cancer Center-Center for Urologic Cancer ( Site 2604)
      • Seongnam, Kyonggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital-Urology ( Site 2602)
    • Seoul
      • Songpagu, Seoul, South Korea, 05505
        • Asan Medical Center-Oncology ( Site 2601)
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)
      • Lugo, Spain, 27003
        • Hospital Lucus Augusti-Oncology ( Site 2706)
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos-Oncology Department ( Site 2703)
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)
    • Gerona
      • Girona, Gerona, Spain, 17007
        • Institut Català d'Oncologia (ICO) - Girona ( Site 2707)
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28034
        • Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)
      • Madrid, Madrid, Comunidad de, Spain, 28041
        • Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46009
        • Fundación Instituto Valenciano de Oncología ( Site 2705)
  • Sweden
    • Stockholm County
      • Stockholm, Stockholm County, Sweden, 171 76
        • Karolinska Universitetssjukhuset Solna ( Site 2802)
    • Uppsala County
      • Uppsala, Uppsala County, Sweden, 751 85
        • Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)
    • Västra Götaland County
      • Gothenburg, Västra Götaland County, Sweden, 413 45
        • Sahlgrenska Universitetssjukhuset ( Site 2801)
  • Taiwan
      • Kaohsiung City, Taiwan, 81362
        • Kaohsiung Veterans General Hospital ( Site 2901)
      • Taichung, Taiwan, 40447
        • China Medical University Hospital-Department of Urology ( Site 2907)
      • Taichung, Taiwan, 407
        • Taichung Veterans General Hospital ( Site 2902)
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital ( Site 2903)
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital ( Site 2904)
      • Taoyuan, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)
    • Taipei
      • Taipei City, Taipei, Taiwan, 11490
        • Tri-Service General Hospital ( Site 2908)
  • Thailand
    • Bangkok
      • Bangkok, Bangkok, Thailand, 10330
        • Chulalongkorn University ( Site 3005)
      • Bangkok, Bangkok, Thailand, 10400
        • Ramathibodi Hospital ( Site 3001)
      • Bangkok, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital ( Site 3002)
    • Changwat Songkhla
      • Hat Yai, Changwat Songkhla, Thailand, 90110
        • Songklanagarind hospital ( Site 3004)
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01250
        • Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)
      • Ankara, Turkey (Türkiye), 06010
        • Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)
      • Ankara, Turkey (Türkiye), 06100
        • Ankara University Hospital Cebeci ( Site 3209)
      • Ankara, Turkey (Türkiye), 06230
        • Hacettepe Universitesi-oncology hospital ( Site 3203)
      • Ankara, Turkey (Türkiye), 6800
        • Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)
      • Istanbul, Turkey (Türkiye), 34722
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Medicine of Faculty-Medical Oncology ( Site 3202)
    • Istanbul
      • Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)
  • United Kingdom
      • Manchester, United Kingdom, M20 4BX
        • The Christie NHS Foundation Trust ( Site 3301)
      • Swansea, United Kingdom, SA2 8QA
        • Singleton Hospital ( Site 3306)
    • England
      • London, England, United Kingdom, NW3 2QG
        • Royal Free Hospital ( Site 3304)
      • Nottingham, England, United Kingdom, NG5 1PF
        • City Hospital, Nottingham University Hospitals ( Site 3303)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)
    • Hammersmith and Fulham
      • London, Hammersmith and Fulham, United Kingdom, W6 8RF
        • Charing Cross Hospital ( Site 3302)
    • London, City of
      • London, London, City of, United Kingdom, EC1A 7BE
        • St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic in Arizona - Phoenix ( Site 3554)
    • California
      • Duarte, California, United States, 91010
        • City of Hope Comprehensive Cancer Center ( Site 3567)
      • La Jolla, California, United States, 92093
        • Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)
      • Los Angeles, California, United States, 90095
        • UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520)
      • Orange, California, United States, 92868
        • University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)
      • Palo Alto, California, United States, 94304
        • Stanford Cancer Center ( Site 3523)
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus ( Site 3514)
      • Grand Junction, Colorado, United States, 81501
        • Intermountain Health St. Mary's Regional Hospital ( Site 3562)
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Georgetown University Medical Center ( Site 3534)
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517)
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center ( Site 3540)
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center at Parkview Regional Medical Center ( Site 3526)
    • Maryland
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital ( Site 3571)
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute-GU ( Site 3505)
    • Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Cancer and Hematology Centers of Western Michigan ( Site 3502)
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University-Internal Medicine/Oncology ( Site 3531)
    • Montana
      • Billings, Montana, United States, 59102
        • St. Vincent Frontier Cancer Center-Research ( Site 3506)
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Englewood Hospital and Medical Center ( Site 3557)
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey ( Site 3541)
    • New York
      • Lake Success, New York, United States, 11042
        • Monter Cancer Center ( Site 3560)
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai ( Site 3539)
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center ( Site 3568)
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center ( Site 3528)
    • Ohio
      • Columbus, Ohio, United States, 43210
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3507)
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19004
        • MidLantic urology ( Site 3501)
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center-GU Oncology ( Site 3535)
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Sanford Cancer Center ( Site 3551)
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The West Clinic, PLLC dba West Cancer Center ( Site 3522)
      • Nashville, Tennessee, United States, 37209
        • Urology Associates ( Site 3512)
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center ( Site 3529)
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center-Urology ( Site 3569)
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Schar Cancer Institute ( Site 3525)
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)

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 (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6482-022
  • MK-6482-022 (Other Identifier: MSD)
  • LITESPARK-022 (Other Identifier: MSD)
  • jRCT2051220030 (Registry Identifier: jRCT)
  • 2021-003436-92 (EudraCT Number)
  • U1111-1290-7346 (Registry Identifier: UTN)
  • 2023-505023-31-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/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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