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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, vs Pembrolizumab and Lenvatinib, for Treatment of Advanced Clear Cell Renal Cell Carcinoma (MK-6482-012)-China Extension Study
Sponsor: Merck Sharp & Dohme LLC
Summary
The goal of this China extension 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 Chinese 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
249
Start Date
2022-07-27
Completion Date
2027-06-07
Last Updated
2025-11-10
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 (17)
Beijing Cancer hospital-Renal carcinoma and melanoma ( Site 6000)
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital ( Site 6009)
Chongqing, Chongqing Municipality, China
SUN YAT-SEN UNIVERSITY CANCER CENTRE ( Site 6003)
Guangzhou, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University-Urology ( Site 6036)
Guangzhou, Guangdong, China
Guangzhou First People's Hospital ( Site 6007)
Guangzhou, Guangdong, China
Henan Cancer Hospital-Urology ( Site 6006)
Zhengzhou, Henan, China
Wuhan Union Hospital ( Site 6002)
Wuhan, Hubei, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School-Urology ( S
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University-Urology ( Site 6025)
Suzhou, Jiangsu, 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
West China Hospital Sichuan University-Urology Surgery ( Site 6016)
Chengdu, Sichuan, China
The Second Hospital of Tianjin Medical University ( Site 6032)
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital, Zhejiang University ( 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