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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)
Sponsor: Merck Sharp & Dohme LLC
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
Official title: A Phase 1b/2 Study of Immune and Targeted Combination Therapies in Participants With RCC (KEYMAKER-U03): Substudy 03C in Participants With Recurrent Disease During or After Anti-PD-(L)1 Adjuvant Therapy
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2025-07-20
Completion Date
2031-10-26
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
Oral Tablet
Zanzalintinib
Oral Tablet
Locations (27)
UCSF Medical Center at Mission Bay ( Site 5008)
San Francisco, California, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026)
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center ( Site 5016)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 5002)
New York, New York, United States
Duke Cancer Institute ( Site 5015)
Durham, North Carolina, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 5017)
Pittsburgh, Pennsylvania, United States
Centro de Estudios Clínicos SAGA ( Site 6110)
Santiago, Region M. de Santiago, Chile
Bradfordhill ( Site 6101)
Santiago, Region M. de Santiago, Chile
C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203)
Strasbourg, Bas-Rhin, France
Institut Claudius Regaud ( Site 5200)
Toulouse, Haute-Garonne, France
Centre Eugene Marquis ( Site 5205)
Rennes, Ille-et-Vilaine, France
Institut De Cancerologie De Lorraine ( Site 5204)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
Gustave Roussy ( Site 5202)
Villejuif, Île-de-France Region, France
Rambam Health Care Campus ( Site 5500)
Haifa, Israel
Rabin Medical Center ( Site 5502)
Petah Tikva, Israel
Sheba Medical Center ( Site 5501)
Ramat Gan, Israel
Sourasky Medical Center ( Site 5503)
Tel Aviv, Israel
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 6201)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne ( Site 6202)
Gdansk, Pomeranian Voivodeship, Poland
Severance Hospital ( Site 5802)
Seoul, South Korea
Asan Medical Center ( Site 5800)
Seoul, South Korea
Samsung Medical Center ( Site 5801)
Seoul, South Korea
Hospital Universitario Ramon y Cajal ( Site 5301)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron ( Site 5300)
Barcelona, Spain
Western General Hospital ( Site 5402)
Edinburgh, Edinburgh, City of, United Kingdom
St Bartholomew's Hospital ( Site 5401)
London, London, City of, United Kingdom
The Christie NHS Foundation Trust ( Site 5400)
Manchester, United Kingdom