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 now · Phase 1/Phase 2
Conditions studied: Renal Cell Carcinoma
In brief
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
Key facts
- Study ID
- NCT07049926
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 140
- Starts
- 2025-07-20
- Expected to finish
- 2031-10-26
- Last updated by the study team
- 2026-07-16
Who can join
Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCSF Medical Center at Mission Bay ( Site 5008) — San Francisco, California, United States (enrolling)
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026) — Mineola, New York, United States (enrolling)
- Laura and Isaac Perlmutter Cancer Center ( Site 5016) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center ( Site 5002) — New York, New York, United States (enrolling)
- Duke Cancer Institute ( Site 5015) — Durham, North Carolina, United States (enrolling)
- UPMC Cancer Center/Hillman Cancer Center ( Site 5017) — Pittsburgh, Pennsylvania, United States (enrolling)
- Vanderbilt University Medical Center ( Site 5004) — Nashville, Tennessee, United States (enrolling)
- Centro de Estudios Clínicos SAGA ( Site 6110) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 6101) — Santiago, Region M. de Santiago, Chile (enrolling)
- C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203) — Strasbourg, Bas-Rhin, France (enrolling)
- Institut Claudius Regaud ( Site 5200) — Toulouse, Haute-Garonne, France (enrolling)
- Centre Eugene Marquis ( Site 5205) — Rennes, Ille-et-Vilaine, France (enrolling)
- Institut De Cancerologie De Lorraine ( Site 5204) — Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France (enrolling)
- Gustave Roussy ( Site 5202) — Villejuif, Île-de-France Region, France (enrolling)
- Rambam Health Care Campus ( Site 5500) — Haifa, Israel (enrolling)
- Rabin Medical Center ( Site 5502) — Petah Tikva, Israel (enrolling)
- Sheba Medical Center ( Site 5501) — Ramat Gan, Israel (enrolling)
- Sourasky Medical Center ( Site 5503) — Tel Aviv, Israel (enrolling)
- Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 6201) — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland (enrolling)
- Uniwersyteckie Centrum Kliniczne ( Site 6202) — Gdansk, Pomeranian Voivodeship, Poland (enrolling)
- Severance Hospital ( Site 5802) — Seoul, South Korea (enrolling)
- Asan Medical Center ( Site 5800) — Seoul, South Korea (enrolling)
- Samsung Medical Center ( Site 5801) — Seoul, South Korea (enrolling)
- Hospital Universitario Ramon y Cajal ( Site 5301) — Madrid, Madrid, Comunidad de, Spain (enrolling)
- Hospital Universitari Vall d'Hebron ( Site 5300) — Barcelona, Spain (enrolling)
Full record on ClinicalTrials.gov
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