NCT04736706

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)

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)

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,653 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-14
• Primary completion: 2026-10-29
• Completion: 2026-10-29
• First posted: 2021-02-03
• Last updated: 2024-11-18

Locations

262 sites across 35 countries: United States, Australia, Brazil, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Finland, France, Germany, Guatemala, Hungary, Ireland, Italy, Japan, Malaysia, Mexico, Norway, Philippines, Poland, Romania, Russia, Serbia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study