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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
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
Conditions
Interventions
Belzutifan
Three 40 mg tablets given as a single oral 120 mg dose.
Pembrolizumab
400 mg via IV infusion
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