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)
Start Date
7/20/2025
Completion Date
10/26/2031
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
Eligibility Criteria
Age Range: 18 years to 120 years
Interventions
Belzutifan
Zanzalintinib
Conditions
Locations
UCSF Medical Center at Mission Bay ( Site 5008)
San Francisco, California 94158
United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 5026)
Mineola, New York 11501
United States
Laura and Isaac Perlmutter Cancer Center ( Site 5016)
New York, New York 10016
United States
Memorial Sloan Kettering Cancer Center ( Site 5002)
New York, New York 10065
United States
Duke Cancer Institute ( Site 5015)
Durham, North Carolina 27710
United States
UPMC Cancer Center/Hillman Cancer Center ( Site 5017)
Pittsburgh, Pennsylvania 15232
United States
Vanderbilt University Medical Center ( Site 5004)
Nashville, Tennessee 37232
United States
Centro de Estudios Clínicos SAGA ( Site 6110)
Santiago, Region M. de Santiago 7500653
Chile
Bradfordhill ( Site 6101)
Santiago, Region M. de Santiago 8420383
Chile
C.H.U. de Strasbourg Hopital de Hautepierre ( Site 5203)
Strasbourg, Bas-Rhin 67098
France
Institut Claudius Regaud ( Site 5200)
Toulouse, Haute-Garonne 31059
France
Centre Eugene Marquis ( Site 5205)
Rennes, Ille-et-Vilaine 35042
France
Institut De Cancerologie De Lorraine ( Site 5204)
Vandœuvre-lès-Nancy, Meurthe-et-Moselle 54513
France
Gustave Roussy ( Site 5202)
Villejuif, Île-de-France Region 94805
France
Rambam Health Care Campus ( Site 5500)
Haifa, 3109601
Israel
Rabin Medical Center ( Site 5502)
Petah Tikva, 4941492
Israel
Sheba Medical Center ( Site 5501)
Ramat Gan, 5265601
Israel
Sourasky Medical Center ( Site 5503)
Tel Aviv, 6423906
Israel
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 6201)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796
Poland
Uniwersyteckie Centrum Kliniczne ( Site 6202)
Gdansk, Pomeranian Voivodeship 80-214
Poland
Severance Hospital ( Site 5802)
Seoul, 03722
South Korea
Asan Medical Center ( Site 5800)
Seoul, 05505
South Korea
Samsung Medical Center ( Site 5801)
Seoul, 06351
South Korea
Hospital Universitario Ramon y Cajal ( Site 5301)
Madrid, Madrid, Comunidad de 28034
Spain
Hospital Universitari Vall d'Hebron ( Site 5300)
Barcelona, 08035
Spain
Western General Hospital ( Site 5402)
Edinburgh, Edinburgh, City of EH42XU
United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 5405)
Glasgow, Glasgow City G12 0YN
United Kingdom
St Bartholomew's Hospital ( Site 5401)
London, London, City of EC1A7BE
United Kingdom
Velindre Cancer Centre ( Site 5407)
Cardiff, CF14 2TL
United Kingdom
The Christie NHS Foundation Trust ( Site 5400)
Manchester, M20 4BX
United Kingdom