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)

NCT05239728 | Active Not Recruiting Phase 3 DMC FDA Drug

• 7 other identifiers: 6482-022MK-6482-022LITESPARK-022jRCT20512200302023-505023-31-00U1111-1290-73462021-003436-92
• Study Type: interventional
• Target: 1,800
• Locations: 32 countries
• Sites: 285

Brief Summary

The purpose of this study is to assess the efficacy and safety of oral belzutifan (MK-6482) plus intravenous (IV) pembrolizumab (MK-3475) compared to placebo plus pembrolizumab, in the adjuvant treatment of Clear Cell Renal Cell Carcinoma (ccRCC) post nephrectomy. The primary study hypothesis is that belzutifan plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS).

Conditions

Carcinoma, Renal Cell

Keywords

Programmed Cell Death-1 (PD1, PD-1); Programmed Cell Death 1 Ligand 1(PDL1, PD-L1); Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2); Hypoxia inducible factor 2 alpha (HIF-2 alpha); Hypoxia inducible factor 2α (HIF-2α)

Outcome Measures

Primary Outcomes (1)

• Disease-Free Survival (DFS)

  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 Outcomes (9)

• Overall Survival (OS)

  Up to approximately 89 months

• Number of Participants Who Experience at Least One Adverse Event (AE)

  Up to approximately 66 weeks

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 54 weeks

• Disease Recurrence-Specific Survival 1 (DRSS1)

  Up to approximately 54 months

• Disease Recurrence-Specific Survival 2 (DRSS2)

  Up to approximately 54 months

Study Arms (2)

Belzutifan + Pembrolizumab

EXPERIMENTAL

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; Biological: Pembrolizumab

Placebo + Pembrolizumab

EXPERIMENTAL

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).

Biological: Pembrolizumab; Drug: Placebo

Interventions

Belzutifan DRUG

Three 40 mg tablets given as a single oral 120 mg dose.

Also known as: MK-6482, PT2977, WELIREG™

Belzutifan + Pembrolizumab

Pembrolizumab BIOLOGICAL

400 mg via IV infusion

Also known as: MK-3475, Keytruda®

Belzutifan + Pembrolizumab; Placebo + Pembrolizumab

Placebo DRUG

Oral tablet

Placebo + Pembrolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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:
• Intermediate-high risk RCC: pT2, Grade 4 or sarcomatoid, N0, M0; pT3, any grade, N0, M0
• High risk RCC: pT4, any Grade N0, M0; pT any stage, any Grade, N+, M0
• 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
• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (285)

Mayo Clinic in Arizona - Phoenix ( Site 3554)

Phoenix, Arizona, 85054, United States

Location

City of Hope Comprehensive Cancer Center ( Site 3567)

Duarte, California, 91010, United States

Location

Moores Cancer Center-Clinical Trials Office- Genitourinary ( Site 3516)

La Jolla, California, 92093, United States

Location

UCLA Hematology/Oncology - Westwood (Building 200 Suite 140)-Department of Urology/Institute of Uro ( Site 3520)

Los Angeles, California, 90095, United States

Location

University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 3518)

Orange, California, 92868, United States

Location

Stanford Cancer Center ( Site 3523)

Palo Alto, California, 94304, United States

Location

University of Colorado Anschutz Medical Campus ( Site 3514)

Aurora, Colorado, 80045, United States

Location

Intermountain Health St. Mary's Regional Hospital ( Site 3562)

Grand Junction, Colorado, 81501, United States

Location

Georgetown University Medical Center ( Site 3534)

Washington D.C., District of Columbia, 20007, United States

Location

University of Miami Hospital and Clinics, Sylvester Cancer Center-Cancer Research Services ( Site 3517)

Miami, Florida, 33136, United States

Location

Moffitt Cancer Center ( Site 3540)

Tampa, Florida, 33612, United States

Location

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 3515)

Marietta, Georgia, 30060, United States

Location

Parkview Research Center at Parkview Regional Medical Center ( Site 3526)

Fort Wayne, Indiana, 46845, United States

Location

Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center- GU Oncology ( Site 3549)

Baltimore, Maryland, 21231, United States

Location

Massachusetts General Hospital ( Site 3571)

Boston, Massachusetts, 02114, United States

Location

Beth Israel Deaconess Medical Center-Cancer Clinical Trials Office ( Site 3572)

Boston, Massachusetts, 02215, United States

Location

Dana-Farber Cancer Institute-GU ( Site 3505)

Boston, Massachusetts, 02215, United States

Location

Cancer and Hematology Centers of Western Michigan ( Site 3502)

Grand Rapids, Michigan, 49503, United States

Location

Washington University-Internal Medicine/Oncology ( Site 3531)

St Louis, Missouri, 63110, United States

Location

St. Vincent Frontier Cancer Center-Research ( Site 3506)

Billings, Montana, 59102, United States

Location

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 3550)

Omaha, Nebraska, 68130, United States

Location

Englewood Hospital and Medical Center ( Site 3557)

Englewood, New Jersey, 07631, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 3541)

New Brunswick, New Jersey, 08903, United States

Location

Monter Cancer Center ( Site 3560)

Lake Success, New York, 11042, United States

Location

Icahn School of Medicine at Mount Sinai ( Site 3539)

New York, New York, 10029, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 3568)

New York, New York, 10065, United States

Location

University of Rochester Medical Center ( Site 3528)

Rochester, New York, 14642, United States

Location

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 3507)

Columbus, Ohio, 43210, United States

Location

MidLantic urology ( Site 3501)

Bala-Cynwyd, Pennsylvania, 19004, United States

Location

Fox Chase Cancer Center-GU Oncology ( Site 3535)

Philadelphia, Pennsylvania, 19111, United States

Location

Sanford Cancer Center ( Site 3551)

Sioux Falls, South Dakota, 57104, United States

Location

The West Clinic, PLLC dba West Cancer Center ( Site 3522)

Germantown, Tennessee, 38138, United States

Location

Urology Associates ( Site 3512)

Nashville, Tennessee, 37209, United States

Location

UT Southwestern Medical Center ( Site 3529)

Dallas, Texas, 75390, United States

Location

University of Texas MD Anderson Cancer Center-Urology ( Site 3569)

Houston, Texas, 77030, United States

Location

Inova Schar Cancer Institute ( Site 3525)

Fairfax, Virginia, 22031, United States

Location

Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 3524)

Seattle, Washington, 98109, United States

Location

Blacktown Hospital ( Site 0002)

Blacktown, New South Wales, 2148, Australia

Location

Macquarie University-MQ Health Clinical Trials Unit ( Site 0003)

Macquarie University, New South Wales, 2109, Australia

Location

Tamworth Hospital-North West Cancer Centre ( Site 0006)

North Tamworth, New South Wales, 2340, Australia

Location

Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)

Brisbane, Queensland, 4029, Australia

Location

Lyell McEwin Hospital-Oncology Clinical Trials Unit ( Site 0008)

Elizabeth Vale, South Australia, 5112, Australia

Location

Austin Health-Cancer Clinical Trials Centre ( Site 0005)

Heidelberg, Victoria, 3084, Australia

Location

Fiona Stanley Hospital-Medical Oncology ( Site 0004)

Murdoch, Western Australia, 6150, Australia

Location

Hospital São Carlos-Oncocentro Ce ( Site 0104)

Fortaleza, Ceará, 60135-237, Brazil

Location

Centro Avançado de Tratamento Oncológico- CENANTRON-Clinical Research ( Site 0105)

Belo Horizonte, Minas Gerais, 30130090, Brazil

Location

Instituto do Câncer e Transplante de Curitiba ( Site 0102)

Curitiba, Paraná, 80510-130, Brazil

Location

Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica ( Site 0103)

Natal, Rio Grande do Norte, 59075-740, Brazil

Location

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0101)

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

Hospital de Clínicas de Ribeirão Preto ( Site 0112)

Ribeirão Preto, São Paulo, 14048900, Brazil

Location

BP - A Beneficencia Portuguesa de São Paulo ( Site 0111)

São Paulo, 01321-001, Brazil

Location

MBAL Uni Hospital-Department of Medical Oncology ( Site 0204)

Panagyurishte, Pazardzhik, 4500, Bulgaria

Location

MHAT Serdika-Second Department of Medical Oncology ( Site 0203)

Sofia, Sofia (stolitsa), 1301, Bulgaria

Location

Complex Cancer Center Plovdiv-First Medical Oncology Department ( Site 0205)

Plovdiv, 4004, Bulgaria

Location

Arthur J.E. Child Comprehensive Cancer Centre ( Site 3706)

Calgary, Alberta, T2N 5G2, Canada

Location

BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)

Hamilton, Ontario, L8V 5C2, Canada

Location

London Health Sciences Centre ( Site 3705)

London, Ontario, N6A 5W9, Canada

Location

Princess Margaret Cancer Centre ( Site 3703)

Toronto, Ontario, M5G 2M9, Canada

Location

CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 3708)

Montreal, Quebec, H1T 2M4, Canada

Location

McGill University Health Centre ( Site 3709)

Montreal, Quebec, H4A 3J1, Canada

Location

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3701)

Québec, Quebec, G1J 1Z4, Canada

Location

James Lind Centro de Investigacion del Cancer ( Site 0307)

Temuco, Araucania, 4800827, Chile

Location

Clínica Puerto Montt ( Site 0309)

Port Montt, Los Lagos Region, 5500243, Chile

Location

Oncocentro Valdivia ( Site 0312)

Valdivia, Los Ríos Region, 5112129, Chile

Location

FALP-UIDO ( Site 0302)

Santiago, Region M. de Santiago, 7500921, Chile

Location

Oncovida ( Site 0306)

Santiago, Region M. de Santiago, 7500994, Chile

Location

Bradfordhill ( Site 0305)

Santiago, Region M. de Santiago, 8420383, Chile

Location

ONCOCENTRO APYS-ACEREY ( Site 0301)

Viña del Mar, Valparaiso, 2520598, Chile

Location

Bradford Hill Norte ( Site 0303)

Antofagasta, 1240000, Chile

Location

The First Affiliated Hospital of Bengbu Medical University- Urology Surgery ( Site 0438)

Bengbu, Anhui, 233004, China

Location

The Second Hospital Of Anhui Medical University ( Site 0416)

Hefei, Anhui, 230000, China

Location

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0435)

Beijing, Beijing Municipality, 100021, China

Location

Beijing Cancer hospital-Urinary Surgery ( Site 0406)

Beijing, Beijing Municipality, 100142, China

Location

First Medical Center of Chinese PLA General Hospital ( Site 0415)

Beijing, Beijing Municipality, 100853, China

Location

Peking University First Hospital-Urology ( Site 0407)

Beijing, Beijing Municipality, 102627, China

Location

Chongqing University Cancer Hospital ( Site 0414)

Chongqing, Chongqing Municipality, 400030, China

Location

Army Medical Center of People's Liberation Army ( Site 0439)

Chongqing, Chongqing Municipality, 400042, China

Location

The First Affiliated Hospital of Fujian Medical University ( Site 0445)

Fuzhou, Fujian, 350005, China

Location

Sun Yat-sen Memorial Hospital, Sun Yat-sen University ( Site 0402)

Guangzhou, Guangdong, 510000, China

Location

Sun Yat-Sen University Cancer Center ( Site 0417)

Guangzhou, Guangdong, 510060, China

Location

The First Affiliated Hospital of Guangzhou Medical University ( Site 0403)

Guangzhou, Guangdong, 510120, China

Location

Henan Cancer Hospital-Urology ( Site 0441)

Zhengzhou, Henan, 450008, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 0430)

Wuhan, Hubei, 430022, China

Location

Tongji Hospital Tongji Medical College of HUST ( Site 0423)

Wuhan, Hubei, 430030, China

Location

Hubei Cancer Hospital-Urinary surgery ( Site 0419)

Wuhan, Hubei, 430079, China

Location

Hunan Cancer Hospital ( Site 0421)

Changsha, Hunan, 410006, China

Location

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School ( Site 0424)

Nanjing, Jiangsu, 210008, China

Location

The Second Affiliated Hospital of Nanchang University ( Site 0443)

Nanchang, Jiangxi, 330006, China

Location

The First Affiliated Hospital of Nanchang University ( Site 0432)

Nanchang, Jiangxi, 330209, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University ( Site 0431)

Xi'an, Shaanxi, 710061, China

Location

Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 0418)

Shanghai, Shanghai Municipality, 200001, China

Location

Huadong Hospital ( Site 0405)

Shanghai, Shanghai Municipality, 200040, China

Location

Fudan University Shanghai Cancer Center ( Site 0401)

Shanghai, Shanghai Municipality, 200120, China

Location

West China Hospital of Sichuan University-Urology Surgery ( Site 0410)

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University Cancer Institute and Hospital ( Site 0422)

Tianjin, Tianjin Municipality, 300000, China

Location

The first Affiliated Hospital, Zhejiang University School of Medicine ( Site 0428)

Hangzhou, Zhejiang, 310003, China

Location

Zhejiang Provincial People's Hospital ( Site 0426)

Hangzhou, Zhejiang, 310014, China

Location

The First Affiliated Hospital of Ningbo University ( Site 0433)

Ningbo, Zhejiang, 315010, China

Location

The First Affiliated Hospital of Wenzhou Medical University ( Site 0425)

Wenzhou, Zhejiang, 325000, China

Location

Clinica de la Costa S.A.S. ( Site 0506)

Barranquilla, Atlántico, 080020, Colombia

Location

Administradora Country S.A. - Clinica del Country ( Site 0504)

Bogotá, Bogota D.C., 110221, Colombia

Location

Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0505)

Valledupar, Cesar Department, 200001, Colombia

Location

IMAT S.A.S ( Site 0501)

Montería, Departamento de Córdoba, 230002, Colombia

Location

Fakultni Nemocnice u sv. Anny v Brne-Onkologicko-chirurgicke oddeleni ( Site 0603)

Brno, Brno-mesto, 602 00, Czechia

Location

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0605)

Brno, Brno-mesto, 656 53, Czechia

Location

Fakultni nemocnice Ostrava-Klinika onkologicka ( Site 0606)

Ostrava, Moravian-Silesian Region, 708 52, Czechia

Location

Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 0601)

Olomouc, Olomouc Region, 779 00, Czechia

Location

Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 0602)

Prague, Praha 4, 140 59, Czechia

Location

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 0607)

Prague, Praha 5, 150 06, Czechia

Location

Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 0604)

Hradec Králové, 500 05, Czechia

Location

Oulun yliopistollinen sairaala ( Site 0802)

Oulu, North Ostrobothnia, 90220, Finland

Location

Kuopion Yliopistollinen Sairaala-Syöpäkeskus ( Site 0804)

Kuopio, Northern Savonia, 70210, Finland

Location

Tampereen yliopistollinen sairaala ( Site 0805)

Tampere, Pirkanmaa, 33520, Finland

Location

Turku University Hospital ( Site 0801)

Turku, Southwest Finland, 20520, Finland

Location

Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus) ( Site 0803)

Helsinki, Uusimaa, 00290, Finland

Location

CENTRE LEON BERARD-Medical oncology ( Site 0902)

Lyon, Auvergne-Rhône-Alpes, 69373 Cedex 08, France

Location

Hopitaux Universitaires de Strasbourg ( Site 0903)

Strasbourg, Bas-Rhin, 67200, France

Location

Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou ( Site 0908)

Rennes, Brittany Region, 35000, France

Location

ROC37 ( Site 0910)

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

Location

CHU Besançon-Medical oncology ( Site 0904)

Besançon, Doubs, 25000, France

Location

Centre Hospitalier Universitaire d'Angers-Urology ( Site 0901)

Angers, Maine-et-Loire, 49933, France

Location

Hôpital Saint-Louis ( Site 0905)

Paris, 75010, France

Location

Hôpital Européen Georges Pompidou-Service d'Oncologie Médicale ( Site 0906)

Paris, 75015, France

Location

Gustave Roussy ( Site 0907)

Villejuif, Île-de-France Region, 94805, France

Location

Hegau-Bodensee-Klinikum Singen ( Site 1016)

Singen, Baden-Wurttemberg, 78224, Germany

Location

Universitaetsklinikum Tuebingen ( Site 1002)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

klinikum rechts der isar der technischen universität münchen-Urologische Klinik und Poliklinik ( Site 1003)

Munich, Bavaria, 81675, Germany

Location

Universitätsklinikum Aachen ( Site 1024)

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Universitätsklinikum Bonn ( Site 1006)

Bonn, North Rhine-Westphalia, 53127, Germany

Location

Universitaetsklinikum Duesseldorf ( Site 1017)

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Location

Universitaetsklinikum Essen ( Site 1004)

Essen, North Rhine-Westphalia, 45147, Germany

Location

Universitätsklinikum Münster - Albert Schweitzer Campus ( Site 1005)

Münster, North Rhine-Westphalia, 48149, Germany

Location

Universitaetsklinikum des Saarlandes-Klinik fuer Urologie und Kinderurologies ( Site 1020)

Homburg, Saarland, 66421, Germany

Location

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Urologie ( Site 1021)

Dresden, Saxony, 01307, Germany

Location

Krankenhaus Martha-Maria Halle-Dölau-Klinik für Urologie, Kinderurologie und urologische Onkologie ( Site 1008)

Halle, Saxony-Anhalt, 06120, Germany

Location

SRH Wald-Klinikum Gera ( Site 1015)

Gera, Thuringia, 07548, Germany

Location

Universitätsklinikum Jena ( Site 1007)

Jena, Thuringia, 07747, Germany

Location

Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1022)

Berlin, 10117, Germany

Location

Helios Klinikum Berlin-Buch ( Site 1011)

Berlin, 13125, Germany

Location

Universitaetsklinikum Hamburg-Eppendorf-Onkologisches Zentrum ( Site 1001)

Hamburg, 20246, Germany

Location

Alexandra Hospital-ONCOLOGY DEPT. ( Site 1102)

Athens, Attica, 115 28, Greece

Location

Metropolitan Hospital-2nd Oncology Dept ( Site 1104)

Athens, Attica, 185 47, Greece

Location

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1101)

Chaïdári, Attica, 124 62, Greece

Location

Euromedica General Clinic Thessaloniki-Oncology Unit ( Site 1103)

Thessaloniki, 546 45, Greece

Location

European Interbalkan Medical Center-Oncology Department ( Site 1105)

Thessaloniki, 570 01, Greece

Location

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ ( Site 1319)

Szeged, Csongrád megye, 6725, Hungary

Location

Petz Aladar Egyetemi Oktato Korhaz-Onkológiai Osztály ( Site 1321)

Győr, Győr-Moson-Sopron, 9024, Hungary

Location

Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1316)

Budapest, Pest County, 1122, Hungary

Location

Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1311)

Kaposvár, Somogy County, 7400, Hungary

Location

Debreceni Egyetem Klinikai Kozpont-Onkológiai Klinika ( Site 1310)

Debrecen, 4032, Hungary

Location

St. Vincent's University Hospital ( Site 1401)

Dublin, Dublin, D04 T6F4, Ireland

Location

Tallaght University Hospital ( Site 1402)

Dublin, Dublin, D24 NR0A, Ireland

Location

Cork University Hospital ( Site 1404)

Cork, T12 E8YV, Ireland

Location

Beaumont Hospital, Dublin-Cancer Clinical Trials & Research Unit ( Site 1403)

Dublin, Dublin 9, Ireland

Location

Soroka Medical Center ( Site 1505)

Beersheba, 8410101, Israel

Location

Rambam Health Care Campus-Oncology ( Site 1502)

Haifa, 3109601, Israel

Location

Hadassah Medical Center-Oncology ( Site 1506)

Jerusalem, 9112001, Israel

Location

Rabin Medical Center-Oncology ( Site 1503)

Petah Tikva, 4941492, Israel

Location

Sheba Medical Center-ONCOLOGY ( Site 1504)

Ramat Gan, 5265601, Israel

Location

Sourasky Medical Center-Oncology ( Site 1501)

Tel Aviv, 6423906, Israel

Location

A.O.U.C. Policlinico di Bari ( Site 1607)

Bari, Apulia, 70124, Italy

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1603)

Meldola, Emilia-Romagna, 47014, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1604)

Rome, Lazio, 00168, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1608)

Milan, Lombardy, 20133, Italy

Location

Azienda Sanitaria Ospedaliera S Luigi Gonzaga-SCDU Oncologia Medica ( Site 1602)

Orbassano, Piedmont, 10043, Italy

Location

Azienda Ospedaliera Universitaria Careggi-SOD ONCOLOGIA MEDICA ( Site 1601)

Florence, Tuscany, 50134, Italy

Location

Azienda USL 8 di Arezzo-Medical Oncology ( Site 1610)

Arezzo, 52100, Italy

Location

IRCCS - AOU di Bologna-Oncologia Medica Ardizzoni ( Site 1605)

Bologna, 40138, Italy

Location

Ospedale San Raffaele-Oncologia Medica ( Site 1606)

Milan, 20132, Italy

Location

Azienda Ospedaliera Santa Maria Terni-SC Oncologia ( Site 1609)

Terni, 05100, Italy

Location

Fujita Health University Hospital ( Site 1709)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 1704)

Kashiwa, Chiba, 277-8577, Japan

Location

Toho University Sakura Medical Center ( Site 1718)

Sakura, Chiba, 285-8741, Japan

Location

Ehime University Hospital ( Site 1714)

Tōon, Ehime, 791-0295, Japan

Location

Sapporo Medical University Hospital ( Site 1702)

Sapporo, Hokkaido, 060-8543, Japan

Location

Hokkaido University Hospital ( Site 1701)

Sapporo, Hokkaido, 060-8648, Japan

Location

Kanagawa Cancer Center ( Site 1703)

Yokohama, Kanagawa, 241-8515, Japan

Location

Nara Medical University Hospital ( Site 1712)

Kashihara, Nara, 634-0813, Japan

Location

Bell Land General Hospital ( Site 1710)

Sakai, Osaka, 599-8247, Japan

Location

The University of Osaka Hospital ( Site 1711)

Suita, Osaka, 565-0871, Japan

Location

Hamamatsu University Hospital ( Site 1708)

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Toranomon Hospital ( Site 1706)

Minato-ku, Tokyo, 105-8470, Japan

Location

Toyama University Hospital ( Site 1713)

Toyoma, Toyama, 930-0194, Japan

Location

Kyushu University Hospital ( Site 1715)

Fukuoka, 812-8582, Japan

Location

Kagoshima University Hospital ( Site 1719)

Kagoshima, 890-8520, Japan

Location

Kumamoto University Hospital ( Site 1716)

Kumamoto, 860-8556, Japan

Location

Okayama University Hospital ( Site 1720)

Okayama, 700-8558, Japan

Location

Nippon Medical School Hospital ( Site 1705)

Tokyo, 113-8603, Japan

Location

Tokyo Women's Medical University Adachi Medical Center ( Site 1717)

Tokyo, 123-8558, Japan

Location

Keio University Hospital ( Site 1707)

Tokyo, 160-8582, Japan

Location

Wakayama Medical University Hospital ( Site 1721)

Wakayama, 641-8510, Japan

Location

University Malaya Medical Centre ( Site 1804)

Lembah Pantai, Kuala Lumpur, 59100, Malaysia

Location

Hospital Pulau Pinang ( Site 1806)

George Town, Pulau Pinang, 10450, Malaysia

Location

Sarawak General Hospital-Radiotherapy Unit ( Site 1805)

Kuching, Sarawak, 93586, Malaysia

Location

Terapias Integrales del Riñon SA de CV ( Site 1910)

Guadalajara, Jalisco, 44260, Mexico

Location

Hospital Civil Fray Antonio Alcalde-Oncology ( Site 1906)

Guadalajara, Jalisco, 44280, Mexico

Location

BRCR Global Mexico - Guadalajara-Research ( Site 1908)

Guadalajara, Jalisco, Mexico

Location

INSTITUTO NACIONAL DE CANCEROLOGIA ( Site 1902)

Mexico City, Mexico City, 14080, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran-Oncologia y Hematologia ( Site 1912)

Mexico City, Mexico City, 14080, Mexico

Location

Filios Alta Medicina ( Site 1903)

Monterrey, Nuevo León, 64460, Mexico

Location

iCan Oncology Center Centro Medico AVE ( Site 1901)

Monterrey, Nuevo León, 64710, Mexico

Location

Hospital H+ Queretaro-Cuidados Oncológicos ( Site 1905)

Querétaro City, Querétaro, 76000, Mexico

Location

BRCR Global Mexico - Queretaro-SMIQ ( Site 1907)

Querétaro City, Querétaro, 76070, Mexico

Location

Centro de Oncología Personalizada ( Site 1911)

Culiacán, Sinaloa, 80040, Mexico

Location

Centro de Investigacion Clinica de Oaxaca ( Site 1904)

Oaxaca City, 68020, Mexico

Location

Oncocenter ( Site 1909)

Puebla City, 72530, Mexico

Location

Ziekenhuis Rijnstate-Rijnstate Centrum Oncologisch Onderzoek ( Site 3113)

Arnhem, Gelderland, 6815 AD, Netherlands

Location

Radboudumc ( Site 3120)

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Maastricht UMC+ ( Site 3104)

Maastricht, Limburg, 6229 HX, Netherlands

Location

Amphia Ziekenhuis, locatie Breda Molengracht ( Site 3103)

Breda, North Brabant, 4818 CK, Netherlands

Location

Maxima Medisch Centrum, locatie Eindhoven ( Site 3116)

Eindhoven, North Brabant, 5600 PD, Netherlands

Location

Amsterdam UMC, locatie AMC ( Site 3105)

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Tergooiziekenhuizen, locatie Hilversum ( Site 3102)

Hilversum, North Holland, 1213 XZ, Netherlands

Location

Spaarne Gasthuis - Hoofddorp-Oncology ( Site 3107)

Hoofddorp, North Holland, 2134 TM, Netherlands

Location

Isala, locatie Zwolle-Oncology ( Site 3111)

Zwolle, Overijssel, 8025 AB, Netherlands

Location

Haaglanden MC - locatie Antoniushove ( Site 3117)

Leidschendam, South Holland, 2501 ck, Netherlands

Location

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 3101)

Schiedam, South Holland, 3118 JH, Netherlands

Location

Haga Ziekenhuis locatie Leyweg-Oncology ( Site 3108)

The Hague, South Holland, 2545 AA, Netherlands

Location

University Medical Center Groningen ( Site 3121)

Groningen, 9713 GZ, Netherlands

Location

St. Antonius Ziekenhuis, locatie Utrecht-Interne geneeskunde ( Site 3112)

Utrecht, 3543 AZ, Netherlands

Location

Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 3106)

Utrecht, 3584 CX, Netherlands

Location

Auckland City Hospital ( Site 2003)

Auckland, 1023, New Zealand

Location

Przychodnia Lekarska KOMED ( Site 2304)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2312)

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2307)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

MICS Centrum Medyczne Torun ( Site 2305)

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Szpital Wojewódzki im. Świętego Lukasza SP ZOZ w Tarnowie ( Site 2311)

Tarnów, Lesser Poland Voivodeship, 33-100, Poland

Location

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2313)

Siedlce, Masovian Voivodeship, 08-110, Poland

Location

Luxmed Onkologia sp. z o. o. ( Site 2303)

Warsaw, Masovian Voivodeship, 01-748, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 2301)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2306)

Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

Location

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wrocławiu ( Site 2309)

Wrocław, Silesian Voivodeship, 50556, Poland

Location

Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 2302)

Koszalin, West Pomeranian Voivodeship, 75-581, Poland

Location

Twoja Przychodnia - Szczecinskie Centrum Medyczne ( Site 2315)

Szczecin, West Pomeranian Voivodeship, 71-434, Poland

Location

Cardiomed SRL Cluj-Napoca ( Site 2406)

Cluj-Napoca, Cluj, 400015, Romania

Location

Amethyst Radiotherapy Center-Oncologie Medicala ( Site 2405)

Florești, Cluj, 407280, Romania

Location

Centrul de Oncologie Sfantul Nectarie-Medical ( Site 2401)

Craiova, Dolj, 200746, Romania

Location

Radiology Therapeutic Center-Oncology ( Site 2404)

Otopeni, Ilfov, 075100, Romania

Location

Cabinet Medical Oncomed ( Site 2403)

Timișoara, Timiș County, 300239, Romania

Location

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L ( Site 2407)

Bucharest, 013812, Romania

Location

National Cancer Centre Singapore ( Site 3601)

Singapore, Central Singapore, 168583, Singapore

Location

National University Hospital ( Site 3602)

Singapore, South West, 119074, Singapore

Location

National Cancer Center-Center for Urologic Cancer ( Site 2604)

Goyang-si, Kyonggi-do, 10408, South Korea

Location

Seoul National University Bundang Hospital-Urology ( Site 2602)

Seongnam, Kyonggi-do, 13620, South Korea

Location

Asan Medical Center-Oncology ( Site 2601)

Songpagu, Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 2603)

Seoul, 06351, South Korea

Location

Institut Català d'Oncologia (ICO) - Girona ( Site 2707)

Girona, Gerona, 17007, Spain

Location

Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2710)

Madrid, Madrid, Comunidad de, 28034, Spain

Location

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 2708)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Fundación Instituto Valenciano de Oncología ( Site 2705)

Valencia, Valenciana, Comunitat, 46009, Spain

Location

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2702)

Barcelona, 08035, Spain

Location

Hospital Lucus Augusti-Oncology ( Site 2706)

Lugo, 27003, Spain

Location

Hospital Clinico San Carlos-Oncology Department ( Site 2703)

Madrid, 28040, Spain

Location

Hospital Universitario Virgen de la Victoria-Phase II-III-IV Trials ( Site 2709)

Málaga, 29010, Spain

Location

Karolinska Universitetssjukhuset Solna ( Site 2802)

Stockholm, Stockholm County, 171 76, Sweden

Location

Akademiska sjukhuset-Blod- och tumörsjukdomar ( Site 2803)

Uppsala, Uppsala County, 751 85, Sweden

Location

Sahlgrenska Universitetssjukhuset ( Site 2801)

Gothenburg, Västra Götaland County, 413 45, Sweden

Location

Chang Gung Memorial Hospital at Kaohsiung-Oncology and Hematology ( Site 2905)

Kaohsiung Niao Sung Dist, Kaohsiung, 83301, Taiwan

Location

Tri-Service General Hospital ( Site 2908)

Taipei City, Taipei, 11490, Taiwan

Location

Kaohsiung Veterans General Hospital ( Site 2901)

Kaohsiung City, 81362, Taiwan

Location

China Medical University Hospital-Department of Urology ( Site 2907)

Taichung, 40447, Taiwan

Location

Taichung Veterans General Hospital ( Site 2902)

Taichung, 407, Taiwan

Location

National Taiwan University Hospital ( Site 2904)

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital ( Site 2903)

Taipei, 112, Taiwan

Location

Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 2906)

Taoyuan, 333, Taiwan

Location

Chulalongkorn University ( Site 3005)

Bangkok, Bangkok, 10330, Thailand

Location

Ramathibodi Hospital ( Site 3001)

Bangkok, Bangkok, 10400, Thailand

Location

Faculty of Medicine Siriraj Hospital ( Site 3002)

Bangkok, Bangkok, 10700, Thailand

Location

Songklanagarind hospital ( Site 3004)

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

Istanbul Universitesi Cerrahpasa-Internal Diseases ( Site 3204)

Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)

Location

Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 3208)

Adana, 01250, Turkey (Türkiye)

Location

Ankara Gülhane Eitim ve Aratrma Hastanesi-Oncology ( Site 3207)

Ankara, 06010, Turkey (Türkiye)

Location

Ankara University Hospital Cebeci ( Site 3209)

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe Universitesi-oncology hospital ( Site 3203)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Bilkent Şehir Hastanesi-oncology ( Site 3206)

Ankara, 6800, Turkey (Türkiye)

Location

TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 3201)

Istanbul, 34722, Turkey (Türkiye)

Location

Ege University Medicine of Faculty-Medical Oncology ( Site 3202)

Izmir, 35100, Turkey (Türkiye)

Location

Royal Free Hospital ( Site 3304)

London, England, NW3 2QG, United Kingdom

Location

City Hospital, Nottingham University Hospitals ( Site 3303)

Nottingham, England, NG5 1PF, United Kingdom

Location

Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 3305)

Glasgow, Glasgow City, G12 0YN, United Kingdom

Location

Charing Cross Hospital ( Site 3302)

London, Hammersmith and Fulham, W6 8RF, United Kingdom

Location

St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 3307)

London, London, City of, EC1A 7BE, United Kingdom

Location

The Christie NHS Foundation Trust ( Site 3301)

Manchester, M20 4BX, United Kingdom

Location

Singleton Hospital ( Site 3306)

Swansea, SA2 8QA, United Kingdom

Location

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Renal Cell; Parkinson Disease 4, Autosomal Dominant Lewy Body

Interventions

belzutifan; pembrolizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: March 15, 2022
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): September 28, 2029
• Last Updated: May 4, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IE (4); TH (4); US (37); ES (8); CA (8); NZ (1); FI (5); SE (3); GB (7); CN (30); IL (6); MY (3); BU (3); CO (4); FR (9); NL (15); ME (12); CL (8); HU (5); SG (2); DE (16); GR (5); BR (7); AU (7); TW (8); KR (4); TU (8); IT (10); CZ (7); PL (12); JP (21); RO (6)