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Substudy 03A: A Study of Immune and Targeted Combination Therapies in Participants With First Line (1L) Renal Cell Carcinoma (MK-3475-03A)
Sponsor: Merck Sharp & Dohme LLC
Summary
Substudy 03A 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 03A is to evaluate the safety and efficacy of experimental combinations of investigational agents in participants with advanced first line (1L) clear cell renal cell carcinoma (ccRCC). 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 (U03): Substudy 03A in First Line Metastatic Participants
Key Details
Gender
All
Age Range
18 Years - 120 Years
Study Type
INTERVENTIONAL
Enrollment
400
Start Date
2020-12-16
Completion Date
2026-05-31
Last Updated
2026-02-12
Healthy Volunteers
No
Conditions
Interventions
Pembrolizumab
Administered via IV infusion at a dose of 400 mg Q6W
Favezelimab/Pembrolizumab
Administered via IV infusion at a dose of 800 mg/200 mg Q3W
Belzutifan
Administered via oral tablet at a dose of 120 mg QD
Lenvatinib
Administered via oral capsule at a dose of 20 mg QD
Pembrolizumab/Quavonlimab
Administered via IV infusion at a dose of 400 mg/25 mg Q6W
Vibostolimab/Pembrolizumab
Administered via IV infusion at a dose of 200 mg/200 mg Q6W
Locations (55)
University of California at San Francisco ( Site 1008)
San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 1011)
New Haven, Connecticut, United States
University of Chicago ( Site 1013)
Chicago, Illinois, United States
University of Iowa ( Site 1012)
Iowa City, Iowa, United States
Henry Ford Health System ( Site 1014)
Detroit, Michigan, United States
Laura and Isaac Perlmutter Cancer Center ( Site 1016)
New York, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 1002)
New York, New York, United States
Duke Cancer Institute ( Site 1015)
Durham, North Carolina, United States
UPMC Cancer Center/Hillman Cancer Center ( Site 1017)
Pittsburgh, Pennsylvania, United States
UTSW Medical Center ( Site 1003)
Dallas, Texas, United States
Western Sydney Local Health District ( Site 1601)
Blacktown, New South Wales, Australia
St George Hospital ( Site 1602)
Kogarah, New South Wales, Australia
Royal Brisbane and Women s Hospital ( Site 1603)
Herston, Queensland, Australia
Austin Health ( Site 1600)
Heidelberg, Victoria, Australia
Princess Margaret Cancer Centre ( Site 1101)
Toronto, Ontario, Canada
Jewish General Hospital ( Site 1100)
Montreal, Quebec, Canada
FALP-UIDO ( Site 2100)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 2107)
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 2101)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigación del Cáncer ( Site 2108)
Temuco, Región de la Araucanía, Chile
CIDO SpA-Oncology ( Site 2106)
Temuco, Región de la Araucanía, Chile
ONCOCENTRO APYS-ACEREY ( Site 2103)
Viña del Mar, Región de Valparaíso, Chile
Clinica Colsanitas S.A, Sede Clínica Universitaria Colombia-Center Investigator ( Site 1900)
Bogotá, Bogota D.C., Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 1905)
Valledupar, Cesar Department, Colombia
Oncomédica S.A.S ( Site 1904)
Montería, Departamento de Córdoba, Colombia
Fundación Valle del Lili ( Site 1901)
Cali, Valle del Cauca Department, Colombia
Institut De Cancerologie De Lorraine ( Site 1204)
Vandœuvre-lès-Nancy, Ain, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1203)
Strasbourg, Alsace, France
Institut Claudius Regaud ( Site 1200)
Toulouse, Haute-Garonne, France
Gustave Roussy ( Site 1202)
Villejuif, Val-de-Marne, France
Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 2301)
Budapest, Pest County, Hungary
Rambam MC ( Site 1500)
Haifa, Israel
Hadassah Medical Center-Oncology ( Site 1504)
Jerusalem, Israel
Rabin Medical Center ( Site 1502)
Petah Tikva, Israel
Sheba Medical Center - Oncology Division ( Site 1501)
Ramat Gan, Israel
Sourasky Medical Center ( Site 1503)
Tel Aviv, Israel
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)-medical oncology ( Site 2402)
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum ( Site 2401)
Rotterdam, South Holland, Netherlands
Auckland City Hospital ( Site 1700)
Auckland, New Zealand
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2201)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 2200
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 2202)
Gdansk, Pomeranian Voivodeship, Poland
Asan Medical Center ( Site 1800)
Songpagu, Seoul, South Korea
Severance Hospital ( Site 1802)
Seoul, South Korea
Samsung Medical Center ( Site 1801)
Seoul, South Korea
Hospital Universitari Vall d Hebron ( Site 1300)
Barcelona, Catalonia, Spain
Hospital Universitario Ramon y Cajal ( Site 1301)
Madrid, Spain
Southampton General Hospital ( Site 1403)
Southampton, England, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1405)
Glasgow, Glasgow City, United Kingdom
Royal Preston Hospital ( Site 1406)
Preston, Lancashire, United Kingdom
Leicester Royal Infirmary ( Site 1408)
Leicester, Leicestershire, United Kingdom
Barts Health NHS Trust ( Site 1401)
London, London, City of, United Kingdom
Western General Hospital ( Site 1402)
Edinburgh, Midlothian, United Kingdom
Velindre Cancer Centre Hospital ( Site 1407)
Cardiff, Wales, United Kingdom
The Christie NHS Foundation Trust ( Site 1400)
Manchester, United Kingdom