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ACTIVE NOT RECRUITING
NCT05239728
PHASE3

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)

Sponsor: Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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).

Official title: A Multicenter, Double-blind, Randomized Phase 3 Study to Compare the Efficacy and Safety of Belzutifan (MK-6482) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in the Adjuvant Treatment of Clear Cell Renal Cell Carcinoma (ccRCC) Post Nephrectomy (MK-6482-022)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1800

Start Date

2022-03-15

Completion Date

2029-09-28

Last Updated

2026-05-15

Healthy Volunteers

No

Interventions

DRUG

Belzutifan

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

BIOLOGICAL

Pembrolizumab

400 mg via IV infusion

DRUG

Placebo

Oral tablet

Locations (285)

Mayo Clinic in Arizona - Phoenix ( Site 3554)

Phoenix, Arizona, United States

City of Hope Comprehensive Cancer Center ( Site 3567)

Duarte, California, United States

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

La Jolla, California, United States

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

Los Angeles, California, United States

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

Orange, California, United States

Stanford Cancer Center ( Site 3523)

Palo Alto, California, United States

University of Colorado Anschutz Medical Campus ( Site 3514)

Aurora, Colorado, United States

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

Grand Junction, Colorado, United States

Georgetown University Medical Center ( Site 3534)

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

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

Miami, Florida, United States

Moffitt Cancer Center ( Site 3540)

Tampa, Florida, United States

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

Marietta, Georgia, United States

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

Fort Wayne, Indiana, United States

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

Baltimore, Maryland, United States

Massachusetts General Hospital ( Site 3571)

Boston, Massachusetts, United States

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

Boston, Massachusetts, United States

Dana-Farber Cancer Institute-GU ( Site 3505)

Boston, Massachusetts, United States

Cancer and Hematology Centers of Western Michigan ( Site 3502)

Grand Rapids, Michigan, United States

Washington University-Internal Medicine/Oncology ( Site 3531)

St Louis, Missouri, United States

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

Billings, Montana, United States

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

Omaha, Nebraska, United States

Englewood Hospital and Medical Center ( Site 3557)

Englewood, New Jersey, United States

Rutgers Cancer Institute of New Jersey ( Site 3541)

New Brunswick, New Jersey, United States

Monter Cancer Center ( Site 3560)

Lake Success, New York, United States

Icahn School of Medicine at Mount Sinai ( Site 3539)

New York, New York, United States

Memorial Sloan Kettering Cancer Center ( Site 3568)

New York, New York, United States

University of Rochester Medical Center ( Site 3528)

Rochester, New York, United States

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

Columbus, Ohio, United States

MidLantic urology ( Site 3501)

Bala-Cynwyd, Pennsylvania, United States

Fox Chase Cancer Center-GU Oncology ( Site 3535)

Philadelphia, Pennsylvania, United States

Sanford Cancer Center ( Site 3551)

Sioux Falls, South Dakota, United States

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

Germantown, Tennessee, United States

Urology Associates ( Site 3512)

Nashville, Tennessee, United States

UT Southwestern Medical Center ( Site 3529)

Dallas, Texas, United States

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

Houston, Texas, United States

Inova Schar Cancer Institute ( Site 3525)

Fairfax, Virginia, United States

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

Seattle, Washington, United States

Blacktown Hospital ( Site 0002)

Blacktown, New South Wales, Australia

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

Macquarie University, New South Wales, Australia

Tamworth Hospital-North West Cancer Centre ( Site 0006)

North Tamworth, New South Wales, Australia

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

Brisbane, Queensland, Australia

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

Elizabeth Vale, South Australia, Australia

Austin Health-Cancer Clinical Trials Centre ( Site 0005)

Heidelberg, Victoria, Australia

Fiona Stanley Hospital-Medical Oncology ( Site 0004)

Murdoch, Western Australia, Australia

Hospital São Carlos-Oncocentro Ce ( Site 0104)

Fortaleza, Ceará, Brazil

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

Belo Horizonte, Minas Gerais, Brazil

Instituto do Câncer e Transplante de Curitiba ( Site 0102)

Curitiba, Paraná, Brazil

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

Natal, Rio Grande do Norte, Brazil

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

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Ribeirão Preto ( Site 0112)

Ribeirão Preto, São Paulo, Brazil

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

São Paulo, Brazil

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

Panagyurishte, Pazardzhik, Bulgaria

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

Sofia, Sofia (stolitsa), Bulgaria

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

Plovdiv, Bulgaria

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

Calgary, Alberta, Canada

BC Cancer Vancouver-Clinical Trials Unit ( Site 3707)

Vancouver, British Columbia, Canada

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 3710)

Hamilton, Ontario, Canada

London Health Sciences Centre ( Site 3705)

London, Ontario, Canada

Princess Margaret Cancer Centre ( Site 3703)

Toronto, Ontario, Canada

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

Montreal, Quebec, Canada

McGill University Health Centre ( Site 3709)

Montreal, Quebec, Canada

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

Québec, Quebec, Canada

James Lind Centro de Investigacion del Cancer ( Site 0307)

Temuco, Araucania, Chile

Clínica Puerto Montt ( Site 0309)

Port Montt, Los Lagos Region, Chile

Oncocentro Valdivia ( Site 0312)

Valdivia, Los Ríos Region, Chile

FALP-UIDO ( Site 0302)

Santiago, Region M. de Santiago, Chile

Oncovida ( Site 0306)

Santiago, Region M. de Santiago, Chile

Bradfordhill ( Site 0305)

Santiago, Region M. de Santiago, Chile

ONCOCENTRO APYS-ACEREY ( Site 0301)

Viña del Mar, Valparaiso, Chile

Bradford Hill Norte ( Site 0303)

Antofagasta, Chile

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

Bengbu, Anhui, China

The Second Hospital Of Anhui Medical University ( Site 0416)

Hefei, Anhui, China

Cancer Hospital Chinese Academy of Medical Sciences ( Site 0435)

Beijing, Beijing Municipality, China

Beijing Cancer hospital-Urinary Surgery ( Site 0406)

Beijing, Beijing Municipality, China

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

Beijing, Beijing Municipality, China

Peking University First Hospital-Urology ( Site 0407)

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital ( Site 0414)

Chongqing, Chongqing Municipality, China

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

Chongqing, Chongqing Municipality, China

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

Fuzhou, Fujian, China

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

Guangzhou, Guangdong, China

Sun Yat-Sen University Cancer Center ( Site 0417)

Guangzhou, Guangdong, China

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

Guangzhou, Guangdong, China

Henan Cancer Hospital-Urology ( Site 0441)

Zhengzhou, Henan, China

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

Wuhan, Hubei, China

Tongji Hospital Tongji Medical College of HUST ( Site 0423)

Wuhan, Hubei, China

Hubei Cancer Hospital-Urinary surgery ( Site 0419)

Wuhan, Hubei, China

Hunan Cancer Hospital ( Site 0421)

Changsha, Hunan, China

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

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University ( Site 0443)

Nanchang, Jiangxi, China

The First Affiliated Hospital of Nanchang University ( Site 0432)

Nanchang, Jiangxi, China

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

Xi'an, Shaanxi, China

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

Shanghai, Shanghai Municipality, China

Huadong Hospital ( Site 0405)

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center ( Site 0401)

Shanghai, Shanghai Municipality, China

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

Chengdu, Sichuan, China

Tianjin Medical University Cancer Institute and Hospital ( Site 0422)

Tianjin, Tianjin Municipality, China

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

Hangzhou, Zhejiang, China

Zhejiang Provincial People's Hospital ( Site 0426)

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Ningbo University ( Site 0433)

Ningbo, Zhejiang, China

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

Wenzhou, Zhejiang, China

And 185 more locations on ClinicalTrials.gov