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A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Sponsor: Merck Sharp & Dohme LLC
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.
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
747
Start Date
2021-02-25
Completion Date
2027-02-11
Last Updated
2026-03-05
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
Immediate-release 40 mg tablet
Lenvatinib
Capsule available in 4 mg and 10 mg dosages
Cabozantinib
Tablet available in 20 mg, 40 mg and 60 mg dosages
Locations (184)
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 D.C., 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 Province, Argentina
Sanatorio Parque ( Site 0806)
Rosario, Santa Fe Province, 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
Medizinische Universitätsklinik Graz ( Site 1051)
Graz, Styria, Austria
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)
Linz, Upper Austria, Austria
Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)
Vienna, Vienna, Austria
Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)
Vienna, Austria
Medizinische Universität Wien ( Site 1021)
Vienna, 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)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 1101)
Leuven, Vlaams-Brabant, Belgium
CHU de Liege ( Site 1102)
Liège, 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)
São Paulo, Brazil
Hospital Paulistano - Amil Clinical Research ( Site 0308)
São 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
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)
Sherbrooke, Quebec, Canada
Bradfordhill-Clinical Area ( Site 0400)
Santiago, Region M. de Santiago, Chile
James Lind Centro de Investigación del Cáncer ( Site 0402)
Temuco, Región de la Araucanía, Chile
Fundación Colombiana de Cancerología Clínica Vida ( Site 0505)
Medellín, Antioquia, Colombia
Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)
Valledupar, Cesar Department, Colombia
Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)
Bogotá, Cundinamarca, Colombia
Fundación Cardiovascular de Colombia ( Site 0501)
Piedecuesta, Santander Department, Colombia
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)
Brno, Brno-mesto, Czechia
Nemocnice České Budějovice-Onkologicke oddeleni ( Site 2204)
České Budějovice, Jihočeský 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)
Prague, Praha 5, Czechia
Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)
Hradec Králové, Czechia
Tampereen yliopistollinen sairaala ( Site 1801)
Tampere, Pirkanmaa, Finland
TYKS ( Site 1802)
Turku, Southwest Finland, Finland
HYKS ( Site 1800)
Helsinki, Uusimaa, 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 im Breisgau, Baden-Wurttemberg, Germany
NCT-Department of Medical Oncology ( Site 1320)
Heidelberg, Baden-Wurttemberg, Germany
Klinikum Nuernberg Nord ( Site 1300)
Nuremberg, Bavaria, Germany
Universitaetsklinikum Frankfurt ( Site 1301)
Frankfurt am Main, Hesse, Germany
Universitaetsklinikum Aachen AOER ( Site 1317)
Aachen, North Rhine-Westphalia, Germany
Universitaetsklinikum des Saarlandes ( Site 1305)
Homburg/ Saar, Saarland, Germany
Krankenhaus Martha Maria Halle-Doelau ( Site 1314)
Halle, Saxony-Anhalt, Germany
Helios Klinikum Erfurt GmbH ( Site 1315)
Erfurt, Thuringia, 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)
Pátrai, Achaia, Greece
Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)
Athens, Attica, Greece
Athens Medical Center ( Site 3303)
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)
Chaïdári, Attica, Greece
European Interbalkan Medical Center-Oncology Department ( Site 3300)
Thessaloniki, Greece
Mater Misericordiae University Hospital ( Site 3201)
Dublin, 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)
Milan, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)
Milan, 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-ken, 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, Hyōgo, 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)
Sayama, 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
Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)
Sittard-Geleen, Limburg, Netherlands
Amphia Hospital Location Molengracht ( Site 1912)
Breda, North Brabant, Netherlands
Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)
Amsterdam, North Holland, Netherlands
Medisch Centrum Leeuwarden ( Site 1905)
Leeuwarden, Provincie Friesland, Netherlands
Erasmus MC ( Site 1913)
Rotterdam, South Holland, Netherlands
Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)
Schiedam, South Holland, Netherlands
Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)
The Hague, South Holland, Netherlands
Universitair Medisch Centrum Utrecht ( Site 1910)
Utrecht, Netherlands
Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 240
Krakow, Lesser Poland Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)
Warsaw, Masovian Voivodeship, 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, Ivanovo Oblast, Russia
FSBI United Hospital with Polyclinic ( Site 2613)
Moscow, Moscow, Russia
SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)
Moscow, Moscow, Russia
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)
Krasnogorsk, Moscow Oblast, Russia
Hadassah Medical-Oncology department ( Site 2609)
Moscow, Moscow Oblast, Russia
Volgograd Regional Uronephrological Center ( Site 2615)
Volzhsky, Volgograd Oblast, Russia
Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)
Yaroslavl, Yaroslavl Oblast, Russia
Chonnam National University Hwasun Hospital-Oncology ( Site 4203)
Hwasun, Jeonranamdo, South Korea
Asan Medical Center ( Site 4200)
Seoul, South Korea
Samsung Medical Center ( Site 4201)
Seoul, South Korea
Complejo Hospitalario Universitario A Coruna ( Site 1502)
A Coruña, 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)
Seville, Spain
Hopitaux Universitaires de Geneve HUG ( Site 1602)
Geneva, Canton of Geneva, Switzerland
Universitaetsspital Zuerich ( Site 1601)
Zurich, Canton of Zurich, Switzerland
Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)
Bellinzona, Canton Ticino, Switzerland
Kantonsspital Graubuenden ( Site 1600)
Chur, Kanton Graubünden, 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