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ACTIVE NOT RECRUITING
NCT05899049
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

BIOLOGICAL

Pembrolizumab

Pembrolizumab 400 mg administered Q6W via IV infusion

DRUG

Belzutifan

Belzutifan 120 mg administered QD via oral tablet

BIOLOGICAL

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

DRUG

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