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Brief Title: A Study of Belzutifan (MK-6482) in Participants With Advanced Renal Cell Carcinoma (MK-6482-013)
Official Title: Phase 2 Study of MK-6482 in Participants With Advanced Renal Cell Carcinoma
Study ID: NCT04489771
Brief Summary: This study will compare the efficacy and safety of two doses of belzutifan in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that the higher dose of belzutifan is superior to the standard dose in terms of objective response rate (ORR).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Georgetown University Medical Center ( Site 0002), Washington, District of Columbia, United States
Univ of Miami- Sylvester Comprehensive Cancer Center ( Site 0023), Miami, Florida, United States
Norton Cancer Institute - St. Matthews ( Site 0025), Louisville, Kentucky, United States
Weinberg Cancer Institute at Franklin Square ( Site 0007), Baltimore, Maryland, United States
Cancer Partners of Nebraska ( Site 0003), Lincoln, Nebraska, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0012), Omaha, Nebraska, United States
New York Oncology Hematology P.C ( Site 0028), Albany, New York, United States
Roswell Park Cancer Institute ( Site 0038), Buffalo, New York, United States
Fox Chase Cancer Center ( Site 0026), Philadelphia, Pennsylvania, United States
Sanford Cancer Center Oncology Clinic ( Site 0031), Sioux Falls, South Dakota, United States
UT West Cancer Center ( Site 0032), Germantown, Tennessee, United States
Urology Associates ( Site 0015), Nashville, Tennessee, United States
University of Texas Southwestern Medical Center at Dallas ( Site 0004), Dallas, Texas, United States
Baylor Scott & White Medical Center - Temple ( Site 0013), Temple, Texas, United States
Huntsman Cancer Institute ( Site 0037), Salt Lake City, Utah, United States
Inova Schar Cancer Institute ( Site 0001), Fairfax, Virginia, United States
Blue Ridge Cancer Care - Roanoke ( Site 0017), Roanoke, Virginia, United States
Kadlec Clinic Hematology and Oncology ( Site 0008), Kennewick, Washington, United States
Macquarie University ( Site 1007), Macquarie University, New South Wales, Australia
Eastern Health - Box Hill Hospital ( Site 1003), Box Hill, Victoria, Australia
Peninsula Health Frankston Hospital ( Site 1001), Frankston, Victoria, Australia
GZA Sint Augustinus ( Site 2003), Wilrijk, Antwerpen, Belgium
Grand Hopital de Charleroi ( Site 2005), Charleroi, Hainaut, Belgium
CHU de Liege ( Site 2002), Liège, Liege, Belgium
UZ Gent ( Site 2004), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 2001), Leuven, Vlaams-Brabant, Belgium
General Hospital of Athens "Alexandra" ( Site 1102), Athens, Attiki, Greece
Athens University Hospital ATTIKON ( Site 1100), Chaidari, Attiki, Greece
University General Hospital of Larissa ( Site 1101), Larissa, Thessalia, Greece
Cork University Hospital ( Site 9053), Cork, , Ireland
Tallaght University Hospital ( Site 9051), Dublin, , Ireland
Soroka Medical Center ( Site 4004), Beer Sheva, , Israel
Rambam Medical Center ( Site 4001), Haifa, , Israel
Rabin Medical Center ( Site 4002), Petach Tikva, , Israel
Sourasky Medical Center ( Site 4003), Tel Aviv, , Israel
Maastricht Universitair Medisch Centrum - MUMC ( Site 5001), Maastricht, Limburg, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 5003), Amsterdam, Noord-Holland, Netherlands
Isala klinieken ( Site 5002), Zwolle, Overijssel, Netherlands
Erasmus MC ( Site 5000), Rotterdam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht ( Site 5004), Utrecht, , Netherlands
Federal state budgetary institution Russian Research Centre of radiology and nuclear medicine ( Site, Moscow, Moskva, Russian Federation
City Clinical Oncology Hospital No. 1 ( Site 6004), Moscow, Moskva, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 6001), Saint Petersburg, Sankt-Peterburg, Russian Federation
Clinical Research Center of specialized types medical care-Oncology ( Site 6002), Saint-Petersburg, Sankt-Peterburg, Russian Federation
Royal Free London NHS Foundation Trust ( Site 9003), London, England, United Kingdom
Imperial College Healthcare NHS Trust ( Site 9004), London, London, City Of, United Kingdom
Churchill Hospital ( Site 9000), Oxford, Oxfordshire, United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 9001), Nottingham, , United Kingdom
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR