Clinical Trial

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)

Active, Not Recruiting Phase 3

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.

Protocol Amendment History 3 changes

notable Enrollment increased: 1653 -> 1854 participants 2026-08-15

notable Primary completion moved earlier: 2026-10-29 -> 2026-02-04 2026-08-15

minor Completion pushed: 2026-10-29 -> 2027-04-22 2026-08-15

Trial Details

NCT Number	NCT04736706
Lead Sponsor	Merck Sharp & Dohme LLC Collaborators: Eisai Inc.
Conditions	Carcinoma, Renal Cell
Enrollment	1,854 participants
Start Date	2021-04-14
Primary Completion	2026-02-04 (estimated)
Study Completion	2027-04-22 (estimated)
Updated on ClinicalTrials.gov	2026-08-14