OncoMatch/Clinical Trials/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)
Is NCT07049926 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Belzutifan and Zanzalintinib for renal cell carcinoma.
Treatment: Belzutifan · Zanzalintinib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Renal Cell Carcinoma
Prior therapy
Must have received: anti-PD-1 therapy — adjuvant
Has received no other prior systemic therapy for treatment of advanced/metastatic clear cell renal cell carcinoma (ccRCC) except for adjuvant programmed cell death ligand 1 (PD-(L)1) therapy; Has disease recurrence during adjuvant anti- PD-(L)1 therapy or ≤24 months following the last dose of adjuvant anti-PD-(L)1 therapy
Lab requirements
Liver function
Has moderate to severe hepatic impairment [excluded]
Cardiac function
Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤140/90 mm Hg with no change in antihypertensive medications within 1 week before allocation/randomization; Has moderate to severe hepatic impairment; Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Medical Center at Mission Bay ( Site 5008) · San Francisco, California
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026) · Mineola, New York
- Laura and Isaac Perlmutter Cancer Center ( Site 5016) · New York, New York
- Memorial Sloan Kettering Cancer Center ( Site 5002) · New York, New York
- Duke Cancer Institute ( Site 5015) · Durham, North Carolina
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