Spots Global Cancer Trial Database for A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
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Trial Identification
Brief Title: A Study of Belzutifan (MK-6482) Versus Everolimus in Participants With Advanced Renal Cell Carcinoma (MK-6482-005)
Official Title: An Open-label, Randomized Phase 3 Study of MK-6482 Versus Everolimus in Participants With Advanced Renal Cell Carcinoma That Has Progressed After Prior PD-1/L1 and VEGF-Targeted Therapies
Study ID: NCT04195750
Conditions
Study Description
Brief Summary: The primary objective of this study is to compare belzutifan to everolimus with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by Blinded Independent Central Review (BICR) and to compare everolimus with respect to overall survival (OS). The hypothesis is that belzutifan is superior to everolimus with respect to PFS and OS.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama - Birmingham ( Site 1538), Birmingham, Alabama, United States
University of California San Diego Moores Cancer Center ( Site 1546), La Jolla, California, United States
St Joseph Heritage Healthcare ( Site 1531), Santa Rosa, California, United States
University Of Colorado ( Site 1540), Aurora, Colorado, United States
UCHealth Highlands Ranch Hospital ( Site 1560), Highlands Ranch, Colorado, United States
Sibley Memorial Hospital ( Site 1559), Washington, District of Columbia, United States
Northwest Georgia Oncology Centers PC ( Site 1520), Marietta, Georgia, United States
The University of Chicago Medical Center ( Site 1539), Chicago, Illinois, United States
Ochsner Medical Center ( Site 1522), New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins ( Site 1514), Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 1558), Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center ( Site 1501), Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 1505), Boston, Massachusetts, United States
Henry Ford Cancer Center ( Site 1511), Detroit, Michigan, United States
Hattiesburg Clinic ( Site 1509), Hattiesburg, Mississippi, United States
St. Vincent Frontier Cancer Center ( Site 1549), Billings, Montana, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 1513), Hackensack, New Jersey, United States
University of Rochester Medical Center ( Site 1543), Rochester, New York, United States
University of North Carolina at Chapel Hill ( Site 1537), Chapel Hill, North Carolina, United States
Oncology Hematology Care, Inc. ( Site 1524), Cincinnati, Ohio, United States
Cleveland Clinic ( Site 1504), Cleveland, Ohio, United States
Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1523), Tulsa, Oklahoma, United States
Oregon Health & Science University ( Site 1553), Portland, Oregon, United States
Abramson Cancer Center ( Site 1525), Philadelphia, Pennsylvania, United States
Fox Chase Cancer Center ( Site 1506), Philadelphia, Pennsylvania, United States
Medical University of South Carolina ( Site 1518), Charleston, South Carolina, United States
Henry Joyce Cancer Clinic ( Site 1544), Nashville, Tennessee, United States
Texas Oncology-Austin Central ( Site 1533), Austin, Texas, United States
Texas Oncology, P.A.-Dallas ( Site 1534), Dallas, Texas, United States
Centro Avancado de Tratamento Oncologico ( Site 1657), Belo Horizonte, Minas Gerais, Brazil
Instituto de Cancer e Transplante de Curitiba ICTR ( Site 1650), Curitiba, Parana, Brazil
Liga Norte Riograndense Contra o Cancer ( Site 1651), Natal, Rio Grande Do Norte, Brazil
Hospital de Clinicas de Porto Alegre ( Site 1655), Porto Alegre, Rio Grande Do Sul, Brazil
Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 1653), Sao Paulo, , Brazil
BC Cancer - Vancouver Center ( Site 0155), Vancouver, British Columbia, Canada
Nova Scotia Health Authority QEII-HSC ( Site 0150), Halifax, Nova Scotia, Canada
Juravinski Cancer Centre ( Site 0154), Hamilton, Ontario, Canada
Sunnybrook Research Institute ( Site 0153), Toronto, Ontario, Canada
Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0151), Montreal, Quebec, Canada
CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0152), Quebec, , Canada
Centro Investigación del Cáncer James Lind ( Site 0004), Temuco, Araucania, Chile
Bradfordhill ( Site 0003), Santiago, Region M. De Santiago, Chile
Fundacion Centro de Investigacion Clinica CIC ( Site 1703), Medellin, Antioquia, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 1709), Valledupar, Cesar, Colombia
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 1702), Bogota, Cundinamarca, Colombia
Administradora Country SA - Clinica del Country ( Site 1701), Bogota, Distrito Capital De Bogota, Colombia
Oncologos del Occidente S.A. ( Site 1708), Pereira, Risaralda, Colombia
Masarykuv onkologicky ustav ( Site 0105), Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 0103), Ostrava, Ostrava Mesto, Czechia
Fakultni nemocnice Hradec Kralove ( Site 0106), Hradec Kralove, , Czechia
Fakultni nemocnice Olomouc ( Site 0104), Olomouc, , Czechia
Fakultni nemocnice Kralovske Vinohrady ( Site 0102), Praha 10, , Czechia
Fakultni Thomayerova nemocnice ( Site 0107), Praha 4, , Czechia
Herlev Hospital ( Site 0251), Herlev, Hovedstaden, Denmark
Aarhus University Hospital Skejby ( Site 0250), Aarhus, Midtjylland, Denmark
Tampereen yliopistollinen sairaala ( Site 0300), Tampere, Pirkanmaa, Finland
Kuopion Yliopistollinen Sairaala ( Site 0304), Kuopio, Pohjois-Savo, Finland
HYKS. ( Site 0302), Helsinki, Uusimaa, Finland
TYKS T-sairaala Syopatautien pkl ( Site 0301), Turku, Varsinais-Suomi, Finland
CHU de Bordeaux Hop St ANDRE ( Site 0359), Bordeaux, Aquitaine, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 0350), Strasbourg, Bas-Rhin, France
Centre Francois Baclesse ( Site 0360), Caen, Calvados, France
CHU Besancon - Hopital Jean Minjoz ( Site 0351), Besancon, Doubs, France
Institut de Cancerologie du Gard - CHU Caremeau ( Site 0352), Nimes, Gard, France
Centre Alexis Vautrin Institut de Cancerologie de Lorraine ( Site 0356), Vandoeuvre les Nancy, Meurthe-et-Moselle, France
Centre Hospitalier Lyon Sud ( Site 0354), Pierre Benite, Rhone, France
Gustave Roussy ( Site 0353), Villejuif, Val-de-Marne, France
Universitaetsklinik fuer Urologie ( Site 0405), Tuebingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Duesseldorf ( Site 0410), Duesseldorf, Nordrhein-Westfalen, Germany
Universitaetsklinikum Essen ( Site 0401), Essen, Nordrhein-Westfalen, Germany
Universitaetsklinikum Magdeburg A.o.R. ( Site 0404), Magdeburg, Sachsen-Anhalt, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 0403), Dresden, Sachsen, Germany
Universitaetsklinikum Jena ( Site 0402), Jena, Thuringen, Germany
Universitaetsmedizin Berlin ( Site 0400), Berlin, , Germany
Universitatsklinikum Hamburg-Eppendorf ( Site 0408), Hamburg, , Germany
Prince of Wales Hospital ( Site 1050), Hong Kong, , Hong Kong
Queen Mary Hospital ( Site 1051), Hong Kong, , Hong Kong
Queen Elizabeth Hospital. ( Site 1052), Kowloon, , Hong Kong
Princess Margaret Hospital. ( Site 1053), Lai Chi Kok, , Hong Kong
Bekes Megyei Kozponti Korhaz - Pandy Kalman Tagkorhaza ( Site 0505), Gyula, Bekes, Hungary
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce, Miskolc, Borsod-Abauj-Zemplen, Hungary
Semmelweis Egyetem ( Site 0501), Budapest, , Hungary
Orszagos Onkologiai Intezet ( Site 0503), Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 0504), Debrecen, , Hungary
Zala Megyei Szent Rafael Korhaz ( Site 0509), Zalaegerszeg, , Hungary
Istituto Oncologico Veneto IRCCS ( Site 0603), Padova, Veneto, Italy
Azienda Ospedaliera Universitaria Integrata Verona - Ospedale Borgo Trento-Oncology Unit ( Site 0605, Verona, Veneto, Italy
Medical Oncology Ospedale San Donato ( Site 0609), Arezzo, , Italy
Azienda Ospedaliera Policlinico di Bari ( Site 0610), Bari, , Italy
Policlinico S. Orsola-Malpighi ( Site 0606), Bologna, , Italy
Istituto Nazionale dei Tumori ( Site 0601), Milano, , Italy
Azienda Ospedaliero Universitaria di Modena Policlinico ( Site 0604), Modena, , Italy
Fondazione Salvatore Maugeri clinica del lavoro ( Site 0600), Pavia, , Italy
Fondazione Policlinico Universitario A. Gemelli ( Site 0607), Roma, , Italy
Azienda Ospedaliera Santa Maria ( Site 0602), Terni, , Italy
Fujita Health University ( Site 1016), Toyoake, Aichi, Japan
National Cancer Center Hospital East ( Site 1001), Kashiwa, Chiba, Japan
Ehime University Hospital ( Site 1014), Toon, Ehime, Japan
Sapporo Medical University Hospital ( Site 1008), Sapporo, Hokkaido, Japan
Yokohama City University Hospital ( Site 1015), Yokohama, Kanagawa, Japan
Kanagawa cancer center ( Site 1021), Yokohama, Kanagawa, Japan
Nara Medical University Hospital ( Site 1009), Kashihara, Nara, Japan
Kindai University Hospital- Osakasayama Campus-Urology ( Site 1011), Osakasayama, Osaka, Japan
Osaka University Hospital ( Site 1006), Suita, Osaka, Japan
Saitama Medical University International Medical Center ( Site 1012), Hidaka-city, Saitama, Japan
Hamamatsu University Hospital ( Site 1005), Hamamatsu, Shizuoka, Japan
Toyama University Hospital ( Site 1013), Toyoma, Toyama, Japan
Yamaguchi University Hospital ( Site 1018), Ube, Yamaguchi, Japan
Kyushu University Hospital ( Site 1007), Fukuoka, , Japan
Hiroshima University Hospital-Hiroshima University Hospital ( Site 1019), Hiroshima, , Japan
Niigata University Medical & Dental Hospital ( Site 1022), Niigata, , Japan
Okayama University Hospital ( Site 1020), Okayama, , Japan
Tokushima University Hospital-Department of Urology ( Site 1017), Tokushima, , Japan
National Cancer Center Hospital ( Site 1003), Tokyo, , Japan
Toranomon Hospital ( Site 1004), Tokyo, , Japan
Nippon Medical School Hospital ( Site 1010), Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 1000), Tokyo, , Japan
Keio University Hospital ( Site 1002), Tokyo, , Japan
National Cancer Center ( Site 1204), Gyeonggi-do, Kyonggi-do, Korea, Republic of
Chungnam National University Hospital ( Site 1205), Daejeon, Taejon-Kwangyokshi, Korea, Republic of
Korea University Anam Hospital ( Site 1203), Seoul, , Korea, Republic of
Severance Hospital Yonsei University Health System ( Site 1202), Seoul, , Korea, Republic of
Asan Medical Center ( Site 1200), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 1201), Seoul, , Korea, Republic of
Akershus universitetssykehus ( Site 0851), Lorenskog, Akershus, Norway
Helse Bergen HF - Haukeland Universitetssykehus ( Site 0854), Bergen, Hordaland, Norway
Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 1151), Krasnoyarsk, Krasnoyarskiy Kray, Russian Federation
Hadassah Medical-Oncology department ( Site 1164), Moscow, Moskovskaya Oblast, Russian Federation
SBIH City clinical hospital named after D.D. Pletniov ( Site 1160), Moscow, Moskva, Russian Federation
N.N. Blokhin NMRCO ( Site 1156), Moscow, Moskva, Russian Federation
Russian Scientific Center of Roentgenoradiology ( Site 1155), Moscow, Moskva, Russian Federation
First Moscow State Medical University n.a. I.M.Sechenov ( Site 1163), Moscow, Moskva, Russian Federation
Central Clinical Hospital with Polyclinic ( Site 1157), Moscow, Moskva, Russian Federation
Omsk Clinical Oncology Dispensary ( Site 1150), Omsk, Omskaya Oblast, Russian Federation
SBHI SPb Clinical Research Centre of specialized types of medical care ( Site 1159), Saint-Petersburg, Sankt-Peterburg, Russian Federation
City clinical oncological dispensary ( Site 1154), Sankt-Petersburg, Sankt-Peterburg, Russian Federation
Russian Scientific Center of Radiology and Surgical Technologies ( Site 1153), St. Petersburg, Sankt-Peterburg, Russian Federation
Instituto Catalan de Oncologia - ICO ( Site 1251), L Hospitalet De Llobregat, Barcelona, Spain
Hospital Universitari Vall d Hebron ( Site 1250), Barcelona, Cataluna, Spain
Hospital General Universitario 12 de Octubre ( Site 1252), Madrid, Madrid, Comunidad De, Spain
Instituto Valenciano de Oncologia - IVO ( Site 1254), Valencia, Valenciana, Comunitat, Spain
Hospital Ramon y Cajal ( Site 1253), Madrid, , Spain
Laenssjukhuset Ryhov ( Site 1853), Jönköping, Jonkopings Lan, Sweden
Malmo Universitetssjukhus ( Site 1851), Malmo, Skane Lan, Sweden
Karolinska Universitetssjukhuset Solna ( Site 1850), Stockholm, Stockholms Lan, Sweden
Norrlands Universitetssjukhus ( Site 1856), Umeå, Vasterbottens Lan, Sweden
Chang Gung Medical Foundation - Kaohsiung ( Site 1104), Kaohsiung, , Taiwan
Taichung Veterans General Hospital ( Site 1105), Taichung, , Taiwan
National Cheng Kung University Hospital ( Site 1103), Tainan, , Taiwan
National Taiwan University Hospital ( Site 1100), Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1101), Taipei, , Taiwan
Chang Gung Medical Foundation-Linkou Branch-Urology ( Site 1106), Taoyuan, , Taiwan
Ankara Universitesi Tip Fakultesi ( Site 1311), Ankara, , Turkey
Hacettepe Universitesi Tip Fakultesi ( Site 1300), Ankara, , Turkey
Gazi Universitesi Tip Fakultesi ( Site 1308), Ankara, , Turkey
Trakya University Medical Faculty Balkan Oncology Hospital ( Site 1302), Edirne, , Turkey
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1305), Istanbul, , Turkey
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1303), Istanbul, , Turkey
Ege Universitesi Tip Fakultesi Hastanesi ( Site 1304), Izmir, , Turkey
Izmir Katip Celebi Universitesi Ataturk Egitim ve Arastirma Hastanesi ( Site 1306), Izmir, , Turkey
MI Dnipr Regional Clinical Hospital named after I.I. Mechnikov ( Site 1453), Dnipropetrovsk, Dnipropetrovska Oblast, Ukraine
MI Precarpathian Clinical Oncology Center ( Site 1452), Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine
Kyiv City Clinical Oncology Center ( Site 1450), Kyiv, Kyivska Oblast, Ukraine
Cambridge University Hospitals NHSFT ( Site 1405), Cambridge, Cambridgeshire, United Kingdom
Western General Hospital ( Site 1400), Edinburgh, Edinburgh, City Of, United Kingdom
The Beatson West of Scotland Cancer Centre ( Site 1402), Glasgow, Glasgow City, United Kingdom
Barts Health NHS Trust ( Site 1407), London, London, City Of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 1403), London, London, City Of, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1409), London, London, City Of, United Kingdom
Royal Marsden Hospital Sutton-Surrey ( Site 1411), Sutton, Surrey, United Kingdom
Medway Maritime Hospital ( Site 1406), Gillingham, , United Kingdom
The Christie NHS Foundation Trust ( Site 1401), Manchester, , United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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