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)
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)
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.
Inclusion Criteria:
Exclusion Criteria:
Grand Rapids, Michigan 49503, United States
Saint Louis Park, Minnesota 55426, United States
Lake Success, New York 11042, United States
New York, New York 10065, United States
Knoxville, Tennessee 37920, United States
Wenatchee, Washington 98801, United States
Macquarie University, New South Wales 2109, Australia
Murdock, Western Australia 6150, Australia
Cachoeiro de Itapemirim, Espírito Santo 29308-014, Brazil
Belo Horizonte, Minas Gerais 30130090, Brazil
São Paulo, 01321-001, Brazil
Québec, Quebec G1J 1Z4, Canada
Bengbu, Anhui 233004, China
Beijing, Beijing Municipality 100021, China
Beijing, Beijing Municipality 100142, China
Chongging, Chongqing Municipality 400030, China
Fuzhou, Fujian 350005, China
Guangzhou, Guangdong 510120, China
Guangzhou, Guangdong 510289, China
Wuhan, Hubei 430022, China
Nanjing, Jiangsu 210008, China
Suzhou, Jiangsu 215004, China
Shanghai, Shanghai Municipality 200001, China
Tianjin, Tianjin Municipality 300060, China
Tianjin, Tianjin Municipality 300211, China
Hangzhou, Zhejiang 310003, China
Wenzhou, Zhejiang 325000, China
Medellín, Antioquia 050024, Colombia
Valledupar, Cesar Department 200001, Colombia
Bogota, Cundinamarca 111511, Colombia
Zagreb, Zagreb County 10000, Croatia
Salcajá, Departamento de Quetzaltenango 09002, Guatemala
Gyula, Bekes County 5700, Hungary
Kecskemét, Bács-Kiskun county 6000, Hungary
Szolnok, Jász-Nagykun-Szolnok 5000, Hungary
Modena, Emilia-Romagna 41125, Italy
Adachi City, Tokyo 123-8558, Japan
Bunkyo-ku, Tokyo 113-8519, Japan
Bunkyo, Tokyo 113-8603, Japan
Minato-ku, Tokyo 105-8470, Japan
Guadalajara, Jalisco 44280, Mexico
Lorenskog, Akershus 1478, Norway
Poznan, Greater Poland Voivodeship 60-569, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Warsaw, Masovian Voivodeship 02-781, Poland
Koszalin, West Pomeranian Voivodeship 75-581, Poland
Krasnoyarsk, Krasnoyarsk Krai 660133, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603074, Russia
Nizhny Novgorod, Nizhny Novgorod Oblast 603081, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Port Elizabeth, Eastern Cape 6045, South Africa
Pretoria, Gauteng 0181, South Africa
Edirne, 22030, Turkey (Türkiye)
Istanbul, 34722, Turkey (Türkiye)
Dnipropetrovsk, Dnipropetrovsk Oblast 49005, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76008, Ukraine
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Kharkiv, Kharkiv Oblast 61037, Ukraine
London, London, City of EC1A 7BE, United Kingdom