drugset / Trial / NCT05899049

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

NCT05899049

Phase 3 Active not recruiting 249 enrolled Merck Sharp & Dohme LLC Eisai Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2022-07-27
Primary completion
2027-06-07
Completion
2027-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Belzutifan Small molecule 120 mg Oral
Subject Pembrolizumab/Quavonlimab Unknown 25 mg Intravenous
Subject Pembrolizumab/Quavonlimab Unknown 400 mg Intravenous
Background Lenvatinib Small molecule 20 mg Oral
Background Pembrolizumab Monoclonal antibody 400 mg Intravenous