Spots Global Cancer Trial Database for A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
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Trial Identification
Brief Title: A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Official Title: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy
Study ID: NCT04586231
Conditions
Study Description
Brief Summary: This study will compare the efficacy and safety of belzutifan + lenvatinib versus cabozantinib in participants with advanced renal cell carcinoma (RCC) with clear cell component after prior therapy. The primary hypothesis is that belzutifan + lenvatinib is superior to cabozantinib in terms of progression-free survival or overall survival.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Ironwood Cancer & Research Centers ( Site 0077), Chandler, Arizona, United States
Cedars Sinai Medical Center ( Site 0027), Los Angeles, California, United States
UCLA Hematology/Oncology - Santa Monica ( Site 0048), Los Angeles, California, United States
St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095), Orange, California, United States
UC Irvine Health ( Site 0029), Orange, California, United States
Providence Saint John's Health Center ( Site 0083), Santa Monica, California, United States
Georgetown University Medical Center ( Site 0006), Washington, District of Columbia, United States
AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 0003), Orlando, Florida, United States
Orlando Health, Inc. ( Site 0035), Orlando, Florida, United States
University Cancer & Blood Center, LLC ( Site 0057), Athens, Georgia, United States
Emory University Hospital ( Site 0012), Atlanta, Georgia, United States
Rush University Medical Center ( Site 0040), Chicago, Illinois, United States
Illinois Cancer Care, PC ( Site 0008), Peoria, Illinois, United States
Parkview Cancer Institute ( Site 0088), Fort Wayne, Indiana, United States
Norton Cancer Institute - St. Matthews ( Site 0065), Louisville, Kentucky, United States
Tulane University School of Medicine ( Site 0098), New Orleans, Louisiana, United States
Lahey Hospital & Medical Center ( Site 0090), Burlington, Massachusetts, United States
Cancer & Hematology Centers of Western Michigan ( Site 0018), Grand Rapids, Michigan, United States
HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005), Saint Louis Park, Minnesota, United States
University of Mississippi Medical Ctr ( Site 0037), Jackson, Mississippi, United States
Cancer Partners of Nebraska ( Site 0086), Lincoln, Nebraska, United States
Rutgers Cancer Institute of New Jersey ( Site 0078), New Brunswick, New Jersey, United States
R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013), Lake Success, New York, United States
Memorial Sloan Kettering Cancer Center ( Site 0055), New York, New York, United States
Levine Cancer Institute ( Site 0004), Charlotte, North Carolina, United States
Duke Cancer Institute ( Site 0096), Durham, North Carolina, United States
Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056), Allentown, Pennsylvania, United States
University of Texas, Southwestern Medical Center ( Site 0015), Dallas, Texas, United States
Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001), Salt Lake City, Utah, United States
University of Vermont Medical Center ( Site 0001), Burlington, Vermont, United States
Blue Ridge Cancer Care - Roanoke ( Site 0043), Roanoke, Virginia, United States
Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093), Seattle, Washington, United States
Confluence Health | Wenatchee Valley Hospital & Clinics ( Site 0061), Wenatchee, Washington, United States
Centro de Urología (CDU) ( Site 0803), Caba, Buenos Aires, Argentina
Hospital Británico de Buenos Aires-Oncology ( Site 0801), Ciudad autónoma de Buenos Aires, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0800), Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Sanatorio Británico-Clinical Oncology Department ( Site 0802), Rosario, Santa Fe, Argentina
Sanatorio Parque ( Site 0806), Rosario, Santa Fe, Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804), Buenos Aires, , Argentina
GenesisCare North Shore ( Site 4011), St Leonards, New South Wales, Australia
Lyell McEwin Hospital ( Site 4004), Elizabeth Vale, South Australia, Australia
Peninsula Health Frankston Hospital ( Site 4001), Frankston, Victoria, Australia
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010), Melbourne, Victoria, Australia
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001), Linz, Oberosterreich, Austria
Medizinische Universitätsklinik Graz ( Site 1051), Graz, Steiermark, Austria
Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031), Vienna, Wien, Austria
Krankenhaus der Barmherzigen Brüder Wien ( Site 1041), Wien, , Austria
Medizinische Universität Wien ( Site 1021), Wien, , Austria
Institut Jules Bordet ( Site 1103), Anderlecht, Bruxelles-Capitale, Region De, Belgium
Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105), Brussels, Bruxelles-Capitale, Region De, Belgium
Grand Hopital de Charleroi ( Site 1104), Charleroi, Hainaut, Belgium
UZ Gent ( Site 1100), Gent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1101), Leuven, Vlaams-Brabant, Belgium
CHU de Liege ( Site 1102), Liege, , Belgium
Liga Norte Riograndense Contra o Cancer ( Site 0313), Natal, Rio Grande Do Norte, Brazil
Centro Gaucho Integrado de Oncologia ( Site 0304), Porto Alegre, Rio Grande Do Sul, Brazil
BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311), Sao Paulo, , Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0308), Sao Paulo, , Brazil
Tom Baker Cancer Centre ( Site 0109), Calgary, Alberta, Canada
Cross Cancer Institute ( Site 0111), Edmonton, Alberta, Canada
BC Cancer Vancouver-Clinical Trials Unit ( Site 0110), Vancouver, British Columbia, Canada
The Moncton Hospital ( Site 0101), Moncton, New Brunswick, Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114), Hamilton, Ontario, Canada
Kingston Health Sciences Centre ( Site 0105), Kingston, Ontario, Canada
The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116), Ottawa, Ontario, Canada
Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113), Toronto, Ontario, Canada
CISSS de la Monteregie-Centre ( Site 0103), Greenfield Park, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102), Sherbrooke, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Quebec, , Canada
James Lind Centro de Investigación del Cáncer ( Site 0402), Temuco, Araucania, Chile
Bradfordhill-Clinical Area ( Site 0400), Santiago, Region M. De Santiago, Chile
Fundación Colombiana de Cancerología Clínica Vida ( Site 0505), Medellin, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508), Valledupar, Cesar, Colombia
Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500), Bogotá, Cundinamarca, Colombia
Fundación Cardiovascular de Colombia ( Site 0501), Piedecuesta, Santander, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203), Brno, Brno-mesto, Czechia
Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204), České Budějovice, Jihocesky Kraj, Czechia
Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200), Prague, Praha 4, Czechia
Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205), Praha, Praha 5, Czechia
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201), Hradec Kralove, , Czechia
Tampereen yliopistollinen sairaala ( Site 1801), Tampere, Pirkanmaa, Finland
HYKS ( Site 1800), Helsinki, Uusimaa, Finland
TYKS ( Site 1802), Turku, Varsinais-Suomi, Finland
Institut Jean Godinot ( Site 1216), Reims, Ain, France
Centre Antoine Lacassagne ( Site 1217), Nice, Alpes-Maritimes, France
Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1218), Strasbourg, Alsace, France
CHU de Bordeaux- Hopital Saint Andre ( Site 1209), Bordeaux, Gironde, France
Institut Claudius Regaud ( Site 1215), Toulouse, Haute-Garonne, France
Clinique Francois Chenieux ( Site 1210), Limoges, Haute-Vienne, France
Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201), Saint Herblain, Loire-Atlantique, France
Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200), Angers, Maine-et-Loire, France
Hopital Tenon ( Site 1213), Paris, , France
Klinik fuer Urologie ( Site 1303), Freiburg, Baden-Wurttemberg, Germany
NCT-Department of Medical Oncology ( Site 1320), Heidelberg, Baden-Wurttemberg, Germany
Klinikum Nuernberg Nord ( Site 1300), Nuremberg, Bayern, Germany
Universitaetsklinikum Frankfurt ( Site 1301), Frankfurt am Main, Hessen, Germany
Universitaetsklinikum Aachen AOER ( Site 1317), Aachen, Nordrhein-Westfalen, Germany
Universitaetsklinikum des Saarlandes ( Site 1305), Homburg/ Saar, Saarland, Germany
Krankenhaus Martha Maria Halle-Doelau ( Site 1314), Halle, Sachsen-Anhalt, Germany
Helios Klinikum Erfurt GmbH ( Site 1315), Erfurt, Thuringen, Germany
Charite Universitaetsmedizin Berlin ( Site 1321), Berlin, , Germany
HELIOS Klinikum Berlin-Buch ( Site 1311), Berlin, , Germany
UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302), Patras, Achaia, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304), Athens, Attiki, Greece
Athens Medical Center ( Site 3303), Athens, Attiki, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301), Chaidari, Attiki, Greece
European Interbalkan Medical Center-Oncology Department ( Site 3300), Thessaloniki, , Greece
Mater Misericordiae University Hospital ( Site 3201), Dublin 7, Dublin, Ireland
Tallaght University Hospital ( Site 3200), Dublin, , Ireland
Mater Private Hospital - Dublin ( Site 3202), Dublin, , Ireland
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407), Meldola, Forli-Cesena, Italy
Istituto Clinico Humanitas Research Hospital ( Site 1406), Rozzano, Milano, Italy
Ospedale San Luigi Gonzaga ( Site 1405), Orbassano, Torino, Italy
Medical Oncology Ospedale San Donato ( Site 1404), Arezzo, , Italy
Azienda Ospedaliera Policlinico di Bari ( Site 1402), Bari, , Italy
IRCCS Ospedale San Raffaele ( Site 1409), Milano, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400), Milano, , Italy
Istituti Clinici Scientifici Maugeri Spa ( Site 1403), Pavia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410), Roma, , Italy
Azienda Ospedaliera S. Maria di Terni ( Site 1401), Terni, , Italy
Ospedale Maggiore Borgo Trento ( Site 1408), Verona, , Italy
Fujita Health University ( Site 5003), Toyoake, Aichi, Japan
National Cancer Center Hospital East ( Site 5000), Kashiwa, Chiba, Japan
Toho University Sakura Medical Center ( Site 5014), Sakura, Chiba, Japan
Sapporo Medical University Hospital ( Site 5008), Sapporo, Hokkaido, Japan
Kobe City Medical Center General Hospital ( Site 5017), Kobe, Hyogo, Japan
Yokohama City University Hospital ( Site 5007), Yokohama, Kanagawa, Japan
Nara Medical University Hospital ( Site 5002), Kashihara, Nara, Japan
Kindai University Hospital- Osakasayama Campus-Urology ( Site 5010), Osakasayama, Osaka, Japan
Osaka University Hospital ( Site 5012), Suita, Osaka, Japan
Hamamatsu University School of Medicine University Hospital ( Site 5004), Hamamatsu, Shizuoka, Japan
Tokyo Medical and Dental University Hospital ( Site 5009), Bunkyo-ku, Tokyo, Japan
Toranomon Hospital ( Site 5001), Minato-ku, Tokyo, Japan
Kyushu University Hospital ( Site 5005), Fukuoka, , Japan
Niigata University Medical & Dental Hospital ( Site 5013), Niigata, , Japan
Osaka International Cancer Institute ( Site 5016), Osaka, , Japan
Nippon Medical School Hospital ( Site 5006), Tokyo, , Japan
Tokyo Women's Medical University Adachi Medical Center ( Site 5015), Tokyo, , Japan
Keio university hospital ( Site 5011), Tokyo, , Japan
Chonnam National University Hwasun Hospital-Oncology ( Site 4203), Hwasun, Jeonranamdo, Korea, Republic of
Asan Medical Center ( Site 4200), Seoul, , Korea, Republic of
Samsung Medical Center ( Site 4201), Seoul, , Korea, Republic of
Medisch Centrum Leeuwarden ( Site 1905), Leeuwarden, Fryslan, Netherlands
Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904), Sittard-Geleen, Limburg, Netherlands
Amphia Hospital Location Molengracht ( Site 1912), Breda, Noord-Brabant, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 1901), Amsterdam, Noord-Holland, Netherlands
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917), Den Haag, Zuid-Holland, Netherlands
Erasmus MC ( Site 1913), Rotterdam, Zuid-Holland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909), Schiedam, Zuid-Holland, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1910), Utrecht, , Netherlands
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402), Bydgoszcz, Kujawsko-pomorskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240, Krakow, Malopolskie, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400), Warszawa, Mazowieckie, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401), Poznan, Wielkopolskie, Poland
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500), Cluj Napoca, Cluj, Romania
Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501), Cluj Napoca, Cluj, Romania
Centrul de Oncologie "Sfântul Nectarie" ( Site 2502), Craiova, Dolj, Romania
Ivanovo Regional Oncology Dispensary ( Site 2616), Ivanovo, Ivanovskaya Oblast, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618), Krasnogorsk, Moskovskaya Oblast, Russian Federation
Hadassah Medical-Oncology department ( Site 2609), Moscow, Moskovskaya Oblast, Russian Federation
FSBI United Hospital with Polyclinic ( Site 2613), Moscow, Moskva, Russian Federation
SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614), Moscow, Moskva, Russian Federation
Volgograd Regional Uronephrological Center ( Site 2615), Volzhsky, Volgogradskaya Oblast, Russian Federation
Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619), Yaroslavl, Yaroslavskaya Oblast, Russian Federation
Complejo Hospitalario Universitario A Coruna ( Site 1502), A Coruna, La Coruna, Spain
Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508), Madrid, Madrid, Comunidad De, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507), Barcelona, , Spain
Hospital Clinic i Provincial ( Site 1500), Barcelona, , Spain
Hospital Santa Creu i Sant Pau ( Site 1501), Barcelona, , Spain
Hospital General Universitario Gregorio Maranon ( Site 1505), Madrid, , Spain
Hospital Clinico San Carlos ( Site 1504), Madrid, , Spain
Hospital Virgen del Rocio ( Site 1503), Sevilla, , Spain
Hopitaux Universitaires de Geneve HUG ( Site 1602), Geneva, Geneve, Switzerland
Kantonsspital Graubuenden ( Site 1600), Chur, Grisons, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604), Bellinzona, Ticino, Switzerland
Universitaetsspital Zuerich ( Site 1601), Zuerich, Zurich, Switzerland
Aberdeen Royal Infirmary-Department of Oncology ( Site 3105), Aberdeen, Aberdeen City, United Kingdom
Royal United Hospital Bath England ( Site 3108), Bath, Bath And North East Somerset, United Kingdom
Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106), Nottingham, England, United Kingdom
Southend University Hospital ( Site 3112), Southend, Essex, United Kingdom
Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107), London, London, City Of, United Kingdom
Mount Vernon Cancer Centre ( Site 3101), Northwood, London, City Of, United Kingdom
Musgrove Park Hospital ( Site 3103), Taunton, Somerset, United Kingdom
Singleton Hospital ( Site 3111), Swansea, Wales, United Kingdom
Contact Details
Name: Medical Director
Affiliation: Merck Sharp & Dohme LLC
Role: STUDY_DIRECTOR
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