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ACTIVE NOT RECRUITING
NCT04586231
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Belzutifan

Immediate-release 40 mg tablet

DRUG

Lenvatinib

Capsule available in 4 mg and 10 mg dosages

DRUG

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