OncRef

Clinical Trial: NCT04626479

Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)

Status:

COMPLETED

Phase:

Phase 1

Lead Sponsor:Merck Sharp & Dohme LLC
Information Provided By:Merck Sharp & Dohme LLC
Last Update Posted:2026-09-25

Study Overview

Brief Summary

Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) 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.

Official Title

A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (U03): Substudy 03A in First Line Metastatic Participants

Conditions

Carcinoma, Renal Cell

Intervention / Treatment

  • Biological: Pembrolizumab
  • Biological: Favezelimab/Pembrolizumab
  • Drug: Belzutifan
  • Drug: Lenvatinib
  • Biological: Pembrolizumab/Quavonlimab
  • Drug: Vibostolimab/Pembrolizumab

Other Study ID Numbers

  • 3475-03A
  • MK-3475-03A
  • 2023-506838-68-00
  • U1111-1294-4527
  • 2019-003609-84
  • 2019
  • 2023

Start Date (Actual)

2020-12-16

Primary Completion Date (Actual)

2026-08-10

Study Completion Date (Actual)

2026-08-10

Enrollment (Actual)

393

Study Type

Interventional

Phase

Phase 1, Phase 2