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Substudy 03B: A Study of Immune and Targeted Combination Therapies in Participants With Second Line Plus (2L+) Renal Cell Carcinoma (MK-3475-03B/KEYMAKER-U03)

NCT04626518 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 370

Last updated 2026-05-06

No results posted yet for this study

Summary

Substudy 03B is part of a larger research study that is testing experimental treatments for renal cell carcinoma (RCC). The larger study is the umbrella study (U03).

The goal of substudy 03B is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced second line plus (2L+) clear cell renal cell carcinoma (ccRCC).

This substudy will have two phases: a safety lead-in phase and an efficacy phase. The safety lead-in phase will be used to demonstrate a tolerable safety profile for the combination of investigational agents. There will be no hypothesis testing in this study.

Conditions

  • Carcinoma, Renal Cell

Interventions

BIOLOGICAL

Pembrolizumab

Administered via IV infusion at a dose of 200 mg Q3W or 400 mg Q6W

BIOLOGICAL

MK-4830

Administered via IV infusion at a dose of 800 mg Q3W

DRUG

Belzutifan

Administered via oral tablet at a dose of 120 mg QD

DRUG

Lenvatinib

Administered via oral capsule at a dose of 20 mg QD

BIOLOGICAL

Pembrolizumab/Quavonlimab

Administered via IV infusion at a dose of 400 mg/25 mg Q6W

BIOLOGICAL

Favezelimab/Pembrolizumab

Administered via IV infusion at a dose of 800 mg/200 mg Q3W

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
2020-12-17
Primary Completion
2026-07-17
Completion
2026-07-17
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • France
  • Hungary
  • Israel
  • Netherlands
  • New Zealand
  • Poland
  • South Korea
  • Spain
  • 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 NCT04626518 on ClinicalTrials.gov