NCT04586231

A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 747 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.

Conditions

• Carcinoma, Renal Cell

Interventions

Type	Name	Description
DRUG	Belzutifan	Immediate-release 40 mg tablet
DRUG	Lenvatinib	Capsule available in 4 mg and 10 mg dosages
DRUG	Cabozantinib	Tablet available in 20 mg, 40 mg and 60 mg dosages

Timeline

• Start date: 2021-02-25
• Primary completion: 2026-02-02
• Completion: 2027-02-11
• First posted: 2020-10-14
• Last updated: 2026-03-05

Locations

184 sites across 25 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Colombia, Czechia, Finland, France, Germany, Greece, Ireland, Italy, Japan, Netherlands, Poland, Romania, Russia, South Korea, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study