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A Study of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or Pembrolizumab/Quavonlimab (MK-1308A) in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)
Sponsor: Merck Sharp & Dohme LLC
Summary
The goal of this study is to evaluate the efficacy and safety of pembrolizumab plus belzutifan plus lenvatinib or pembrolizumab/quavonlimab plus lenvatinib versus pembrolizumab plus lenvatinib as first-line treatment in participants with advanced clear cell renal cell carcinoma (ccRCC). The primary hypotheses are (1) pembrolizumab plus belzutifan plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to progression-free survival (PFS) and overall survival (OS), in advanced ccRCC participants; and (2) pembrolizumab/quavonlimab plus lenvatinib is superior to pembrolizumab plus lenvatinib with respect to PFS and OS, in advanced ccRCC participants.
Official title: An Open-label, Randomized Phase 3 Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Belzutifan (MK-6482) and Lenvatinib (MK-7902), or MK-1308A in Combination With Lenvatinib, Versus Pembrolizumab and Lenvatinib, as First-Line Treatment in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1688
Start Date
2021-04-14
Completion Date
2027-04-22
Last Updated
2026-10-02
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Pembrolizumab 400 mg administered Q6W via IV infusion
Belzutifan
Belzutifan 120 mg administered QD via oral tablet
Pembrolizumab/Quavonlimab
Pembrolizumab/quavonlimab is a co-formulated product composed of pembrolizumab 400 mg in combination with quavonlimab 25 mg, administered Q6W via IV infusion
Lenvatinib
Lenvatinib 20 mg administered QD via oral capsule
Locations (262)
The University of Alabama at Birmingham ( Site 0010)
Birmingham, Alabama, United States
UC San Diego ( Site 0050)
La Jolla, California, United States
Cedars Sinai Medical Center ( Site 0027)
Los Angeles, California, United States
University of California Irvine ( Site 0029)
Orange, California, United States
UCLA Hematology Oncology Santa Monica ( Site 0048)
Santa Monica, California, United States
Hartford Hospital ( Site 0024)
Hartford, Connecticut, United States
Advent Health Hematology & Oncology ( Site 0003)
Orlando, Florida, United States
University Cancer & Blood Center, LLC ( Site 0057)
Athens, Georgia, United States
Emory University Winship Cancer Institute ( Site 0012)
Atlanta, Georgia, United States
Rush University Medical Center ( Site 0040)
Chicago, Illinois, United States
Parkview Cancer Institute ( Site 0088)
Fort Wayne, Indiana, United States
Norton Cancer Institute - St. Matthews ( Site 0065)
Louisville, Kentucky, United States
Ochsner Medical Center ( Site 0049)
New Orleans, Louisiana, United States
New England Cancer Specialists ( Site 0082)
Scarborough, Maine, United States
Massachusetts General Hospital ( Site 0094)
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 0089)
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0093)
Boston, Massachusetts, United States
Lahey Hospital & Medical Center ( Site 0090)
Burlington, Massachusetts, United States
Henry Ford Hospital ( Site 0038)
Detroit, Michigan, United States
Cancer & Hematology Centers of Western Michigan ( Site 0018)
Grand Rapids, Michigan, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)
Saint Louis Park, Minnesota, United States
Regions Hospital ( Site 0095)
Saint Paul, Minnesota, United States
University of Mississippi Medical Center ( Site 0037)
Jackson, Mississippi, United States
Dartmouth Hitchcock Medical Center ( Site 0075)
Lebanon, New Hampshire, United States
Roswell Park Cancer Institute ( Site 0032)
Buffalo, New York, United States
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)
Lake Success, New York, United States
Sidney Kimmel Center for Prostate and Urologic Cancers ( Site 0055)
New York, New York, United States
Oregon Health & Science University ( Site 0071)
Portland, Oregon, United States
Ralph H. Johnson VA Center ( Site 0073)
Charleston, South Carolina, United States
University of Tennessee Medical Center Knoxville ( Site 0019)
Knoxville, Tennessee, United States
Vanderbilt University Medical Center ( Site 0069)
Nashville, Tennessee, United States
UTSW Medical Center ( Site 0015)
Dallas, Texas, United States
Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)
Wenatchee, Washington, United States
Liverpool Hospital ( Site 4006)
Liverpool, New South Wales, Australia
Macquarie University ( Site 4007)
Macquarie University, New South Wales, Australia
Lyell McEwin Hospital ( Site 4004)
Elizabeth Vale, South Australia, Australia
Monash Health ( Site 4008)
Clayton, Victoria, Australia
Fiona Stanley Hospital ( Site 4009)
Murdock, Western Australia, Australia
Oncocentro Ceara ( Site 0309)
Fortaleza, Ceará, Brazil
Centro de Pesquisas Clinicas em Oncologia ( Site 0306)
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Centro Avançado de Tratamento Oncológico- CENATRON-Clinical Research ( Site 0303)
Belo Horizonte, Minas Gerais, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 0308)
Natal, Rio Grande do Norte, Brazil
Hospital de Clinicas de Porto Alegre ( Site 0310)
Porto Alegre, Rio Grande do Sul, Brazil
Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0302)
São Paulo, Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0300)
São Paulo, Brazil
A.C. Camargo Cancer Center ( Site 0301)
São Paulo, Brazil
Arthur J.E. Child Comprehensive Cancer Centre ( Site 0119)
Calgary, Alberta, Canada
BC Cancer - Vancouver Center ( Site 0120)
Vancouver, British Columbia, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0117)
Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0116)
Toronto, Ontario, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0112)
Québec, Quebec, Canada
Centro Investigacion Cancer James Lind ( Site 0402)
Temuco, Araucania, Chile
IC La Serena Research ( Site 0403)
La Serena, Coquimbo Region, Chile
Servicios Medicos Urumed ( Site 0405)
Rancagua, Lbtdr Gen Bernardo O Higgins, Chile
Fundacion Arturo Lopez Perez ( Site 0400)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0401)
Santiago, Region M. de Santiago, Chile
The First Afflilated Hospital of Bengbu Medical College-Urology Surgery ( Site 6041)
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Science-Oncology ( Site 6026)
Beijing, Beijing Municipality, China
Peking University First Hospital ( Site 6011)
Beijing, Beijing Municipality, China
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 6009)
Chongging, Chongqing Municipality, China
The First Affiliated Hospital Of Fujian Medical University-Urology ( Site 6038)
Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University ( Site 6001)
Xiamen, Fujian, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University ( Site 6036)
Guangzhou, Guangdong, China
Guangzhou First People's Hospital ( Site 6007)
Guangzhou, Guangdong, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University-Urology Surgery ( Site 6005)
Guangzhou, Guangdong, China
Harbin Medical University Cancer Hospital-urology ( Site 6015)
Harbin, Heilongjiang, China
Henan Cancer Hospital-Urology ( Site 6006)
Zhengzhou, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology ( Site 6002)
Wuhan, Hubei, China
Xiangya Hospital Central South University ( Site 6034)
Changsha, Hunan, China
Hunan Cancer Hospital ( Site 6020)
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( Site 6022)
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Suzhou, Jiangsu, China
Jiangxi Provincial Cancer Hospital ( Site 6042)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Nanchang University ( Site 6019)
Nanchang, Jiangxi, China
The First Affiliated Hospital of Xi'an Jiaotong University ( Site 6014)
Xi'an, Shaanxi, China
Renji Hospital Shanghai Jiao Tong University School of Medicine ( Site 6017)
Shanghai, Shanghai Municipality, China
Shanghai Tenth People's Hospital ( Site 6023)
Shanghai, Shanghai Municipality, China
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Institute and Hospital ( Site 6029)
Tianjin, Tianjin Municipality, China
The Second Hospital of Tianjin Medical University ( Site 6032)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital Zhejiang University School of Medicine ( Site 6024)
Hangzhou, Zhejiang, China
The First Hospital of Jiaxing ( Site 6033)
Jiaxing, Zhejiang, China
Ningbo First Hospital-Urology ( Site 6028)
Ningbo, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical University-Urology Surgery ( Site 6021)
Wenzhou, Zhejiang, China
Instituto de Cancerología S.A Clínica de las Americas (ICCLA) ( Site 0500)
Medellín, Antioquia, Colombia
Clinica de la Costa S.A.S. ( Site 0502)
Barranquilla, Atlántico, Colombia
Administradora Country SA - Clinica del Country ( Site 0504)
Bogotá, Bogota D.C., Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0505)
Valledupar, Cesar Department, Colombia
Instituto Nacional de Cancerología E.S.E. ( Site 0503)
Bogota, Cundinamarca, Colombia
Oncólogos del Occidente S.A ( Site 0501)
Pereira, Risaralda Department, Colombia
Fundacion Cardiovascular de Colombia ( Site 0506)
Piedecuesta, Santander Department, Colombia
Klinicki Bolnicki Centar Zagreb ( Site 3200)
Zagreb, City of Zagreb, Croatia
Klinički Bolnički Centar Split ( Site 3202)
Split, Split-Dalmatia County, Croatia
Klinicki bolnicki centar "Sestre milosrdnice" ( Site 3201)
Zagreb, Zagreb County, Croatia
Masarykuv onkologicky ustav ( Site 2203)
Brno, Brno-mesto, Czechia
Nemocnice AGEL Novy Jicin a.s. ( Site 2202)
Nový Jičín, Moravian-Silesian Region, Czechia
Fakultni nemocnice Ostrava ( Site 2208)
Ostrava, Moravian-Silesian Region, Czechia
Fakultni nemocnice u sv. Anny v Brne ( Site 2205)
Brno, South Moravian, Czechia