Clinical Trial

Substudy 03C: A Study of Combination Therapies in Participants With Renal Cell Carcinoma With Recurrent Disease During or After Anti-PD-(L)1 Therapy (MK-3475-03C/KEYMAKER-U03)

Recruiting Phase 1/2
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Summary
Substudy 03C 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 03C is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with clear cell renal cell carcinoma (ccRCC) who have recurrent disease during or after anti-programmed cell death 1/programmed cell death ligand 1 (PD-\[L\]1) adjuvant therapy. 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
Protocol Amendment History 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2025-06-25; most recent amendment 2026-07-14.
Status change: Not Yet Recruiting → Recruiting 2025-07-31
Trial Details
NCT Number NCT07049926
Lead Sponsor Merck Sharp & Dohme LLC
Collaborators: Exelixis
Conditions Renal Cell Carcinoma
Enrollment 140 participants
Start Date 2025-07-20
Primary Completion 2031-10-26 (estimated)
Study Completion 2031-10-26 (estimated)
Updated on ClinicalTrials.gov 2026-07-16