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Brief Title: Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Solid Tumors (MK-6482-016)
Official Title: An Open-label, Multicenter, Phase 2 Study to Evaluate the Efficacy and Safety of Pembrolizumab Plus Lenvatinib in Combination With Belzutifan in Multiple Solid Tumors
Study ID: NCT04976634
Brief Summary: The purpose of this study is to determine the safety and efficacy of belzutifan in combination with pembrolizumab and lenvatinib in multiple solid tumors including hepatocellular carcinoma (HCC), colorectal cancer (CRC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancer (BTC), endometrial cancer (EC),and esophageal squamous cell carcinoma (ESCC). There is no formal hypothesis testing in this study.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Arizona Cancer Center-University of Arizona Cancer Center - North Campus ( Site 5047), Tucson, Arizona, United States
City of Hope Comprehensive Cancer Center ( Site 5002), Duarte, California, United States
Cedars-Sinai Medical Center ( Site 5045), Los Angeles, California, United States
UCSF Medical Center at Mission Bay ( Site 5021), San Francisco, California, United States
Yale-New Haven Hospital-Yale Cancer Center ( Site 5013), New Haven, Connecticut, United States
Sibley Memorial Hospital ( Site 5051), Washington, District of Columbia, United States
University of Florida College of Medicine ( Site 5015), Gainesville, Florida, United States
Johns Hopkins Hospital-Sidney Kimmel Comprehensive Cancer Center - GI and Immunology ( Site 5048), Baltimore, Maryland, United States
Brigitte Harris Cancer Pavilion ( Site 5055), Detroit, Michigan, United States
Memorial Sloan Kettering Cancer Center ( Site 5050), New York, New York, United States
Duke Cancer Institute ( Site 5026), Durham, North Carolina, United States
University of Texas MD Anderson Cancer Center-Gastrointestinal Medical Oncology ( Site 5049), Houston, Texas, United States
Inova Schar Cancer Institute ( Site 5039), Fairfax, Virginia, United States
Blue Ridge Cancer Care ( Site 5053), Roanoke, Virginia, United States
Northwest Medical Specialties, PLLC ( Site 5025), Tacoma, Washington, United States
University of Wisconsin Hospitals and Clinics ( Site 5037), Madison, Wisconsin, United States
Gosford Hospital-Oncology Trials ( Site 4004), Gosford, New South Wales, Australia
Westmead Hospital-Department of Medical Oncology ( Site 4001), Westmead, New South Wales, Australia
Northern Hospital-Department of Medical Oncology ( Site 4003), Epping, Victoria, Australia
Cabrini Hospital - Malvern-Cabrini Institute ( Site 4000), Malvern, Victoria, Australia
Antwerp University Hospital-Oncology ( Site 1002), Edegem, Antwerpen, Belgium
Cliniques universitaires Saint-Luc-Medical Oncology ( Site 1001), Brussels, Bruxelles-Capitale, Region De, Belgium
Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 1003), Yvoir, Namur, Belgium
UZ Leuven ( Site 1000), Leuven, Vlaams-Brabant, Belgium
AZ Delta vzw ( Site 1004), Roeselare, West-Vlaanderen, Belgium
Centro Investigación del Cáncer James Lind ( Site 3107), Temuco, Araucania, Chile
Clínica Puerto Montt ( Site 3110), Puerto Montt, Los Lagos, Chile
FALP-UIDO ( Site 3102), Santiago, Region M. De Santiago, Chile
Oncovida ( Site 3108), Santiago, Region M. De Santiago, Chile
Bradfordhill-Clinical Area ( Site 3100), Santiago, Region M. De Santiago, Chile
Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer ( Site 1103), Rennes, Bretagne, France
CHU Besançon-Medical oncology ( Site 1101), Besançon, Doubs, France
CHU Brest Cavale Blanche ( Site 1107), Brest, Finistere, France
Institut Régional du Cancer Montpellier ( Site 1106), Montpellier, Herault, France
Hôpital Beaujon-Oncologie Digestive ( Site 1104), Clichy, Ile-de-France, France
Centre Hospitalier Universitaire de Grenoble-Medical Oncology ( Site 1105), La Tronche, Isere, France
Sainte Catherine Institut du Cancer Avignon Provence ( Site 1108), Avignon, Vaucluse, France
Rambam Health Care Campus-Oncology ( Site 1300), Haifa, , Israel
Hadassah Medical Center-Oncology ( Site 1303), Jerusalem, , Israel
Sheba Medical Center-ONCOLOGY ( Site 1302), Ramat Gan, , Israel
Sourasky Medical Center-Oncology ( Site 1301), Tel Aviv, , Israel
Chonnam National University Hwasun Hospital-Hemato-Oncology ( Site 4105), Hwasun Gun, Jeonranamdo, Korea, Republic of
Keimyung University Dongsan Hospital CRC room 1 ( Site 4104), Daegu, Taegu-Kwangyokshi, Korea, Republic of
Seoul National University Hospital-Internal Medicine ( Site 4103), Seoul, , Korea, Republic of
Severance Hospital, Yonsei University Health System-Medical oncology ( Site 4100), Seoul, , Korea, Republic of
Asan Medical Center-Department of Oncology ( Site 4101), Seoul, , Korea, Republic of
Samsung Medical Center-Division of Hematology/Oncology ( Site 4102), Seoul, , Korea, Republic of
Maastricht UMC+-Medical Oncology ( Site 1501), Maastricht, Limburg, Netherlands
Leids Universitair Medisch Centrum-Medical Oncology ( Site 1504), Leiden, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht-Medical Oncology ( Site 1503), Utrecht, , Netherlands
Auckland City Hospital-Liver Research Unit ( Site 4201), Grafton, Auckland, New Zealand
Auckland City Hospital-Cancer & Blood Research ( Site 4200), Auckland, , New Zealand
Hospital Universitario Central de Asturias-Medical Oncology ( Site 1802), Oviedo, Asturias, Spain
Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 1806), Badalona, Barcelona, Spain
CHUS - Hospital Clinico Universitario-Servicio de Oncologia ( Site 1807), Santiago de Compostela, La Coruna, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1801), Madrid, Madrid, Comunidad De, Spain
Hospital Universitari Vall d'Hebron-Oncology ( Site 1800), Barcelona, , Spain
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR