drugset / Trial / NCT04586231

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

NCT04586231

Phase 3 Active not recruiting 747 enrolled Merck Sharp & Dohme LLC Eisai Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2021-02-25
Primary completion
2026-02-02
Completion
2027-02-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Belzutifan Small molecule 120 mg Oral
Comparator Cabozantinib Small molecule 60 mg Oral
Subject Lenvatinib Small molecule 20 mg Oral

Indications