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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)

NCT04736706 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1653

Last updated 2026-05-06

No results posted yet for this study

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

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

BIOLOGICAL

Pembrolizumab

Pembrolizumab 400 mg administered Q6W via IV infusion

DRUG

Belzutifan

Belzutifan 120 mg administered QD via oral tablet

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-14
Primary Completion
2026-10-29
Completion
2026-10-29
FDA Drug
Yes

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04736706 on ClinicalTrials.gov