drugset / Trial / NCT07049926

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)

NCT07049926

Phase 1/2 Recruiting 140 enrolled Merck Sharp & Dohme LLC Exelixis · collab
Non-randomizedParallel-groupSingle-blindTreatment

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

Timeline

Start
2025-07-20
Primary completion
2031-10-26
Completion
2031-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject Belzutifan Small molecule Oral
Subject Zanzalintinib Small molecule Oral

Indications