A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)

NCT04586231 | Active Not Recruiting Phase 3 DMC FDA Drug

• 6 other identifiers: 6482-011MK-6482-011jRCT20312103112024-510620-39-00U1111-1302-28152020-002075-35
• Study Type: interventional
• Target: 747
• Locations: 24 countries
• Sites: 180

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.

Conditions

Carcinoma, Renal Cell

Outcome Measures

Primary Outcomes (2)

• 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)

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be presented.

  Up to approximately 34 months

• Overall Survival (OS)

  OS is defined as time from randomization to death due to any cause.

  Up to approximately 44 months

Secondary Outcomes (4)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

  Up to approximately 24 months

• Duration of Response (DOR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

  Up to approximately 44 months

• Number of Participants Who Experienced One or More Adverse Events (AEs)

  Up to approximately 44 months

• Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

  Up to approximately 44 months

Study Arms (2)

Belzutifan + Lenvatinib

EXPERIMENTAL

Belzutifan 120 mg and lenvatinib 20 mg orally once a day

Drug: Belzutifan; Drug: Lenvatinib

Cabozantinib

ACTIVE COMPARATOR

Cabozantinib 60 mg orally once a day

Drug: Cabozantinib

Interventions

Belzutifan DRUG

Immediate-release 40 mg tablet

Also known as: PT2977, MK-6482, WELIREG™

Belzutifan + Lenvatinib

Lenvatinib DRUG

Capsule available in 4 mg and 10 mg dosages

Also known as: Lenvima, E7080, MK-7902

Belzutifan + Lenvatinib

Cabozantinib DRUG

Tablet available in 20 mg, 40 mg and 60 mg dosages

Also known as: Cabometyx, Cometriq, XL184, BMS-907351

Cabozantinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unresectable, locally advanced or metastatic clear cell renal cell carcinoma (RCC).
• Disease progression on or after an anti-programmed cell death-1/ligand 1 (PD-1/L1) therapy as either first or second-line treatment for locally advanced/metastatic RCC or as adjuvant treatment or neoadjuvant/adjuvant with progression on or within 6 months of last dose.
• Measurable disease per RECIST 1.1 criteria as assessed by local study investigator.
• Karnofsky performance status (KPS) score of at least 70% assessed within 10 days before randomization.
• Received no more than 2 prior systemic regimens including: one anti-PD-1/L1 containing adjuvant or neoadjuvant/adjuvant regimens with progression on or within 6 months from the last dose of that regimen OR one or 2 regimens for locoregional/advanced disease
• Received only 1 prior antiPD-1/L1 therapy for adjuvant, neoadjuvant/adjuvant or locally advanced/metastatic RCC.
• A male participant is eligible to participate if he is abstinent from heterosexual intercourse or agrees to use contraception during the intervention period and for at least 7 days after the last dose of belzutifan or lenvatinib in the belzutifan+lenvatinib arm, whichever occurs last, and 23 days after the last dose of cabozantinib.
• A female participant is eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: Not a woman of childbearing potential (WOCBP) or a WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 30 days after the last dose of study intervention in the belzutifan+ lenvatinib arm, or 120 days after the last dose of study intervention in the cabozantinib arm.
• Adequately controlled blood pressure.
• Adequate organ function.

You may not qualify if:

• A pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.
• Known additional malignancy that is progressing or has required active treatment within the past 3 years except for basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy.
• Known central nervous system (CNS) metastases and/or carcinomatous meningitis.
• Clinically significant cardiac disease within 6 months of first dose of study intervention.
• Prolongation of QTc interval to \>480 ms.
• Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable.
• Pre-existing ≥Grade 3 gastrointestinal or nongastrointestinal fistula.
• Moderate to severe hepatic impairment.
• History of significant bleeding within 3 months before randomization.
• History of solid organ transplantation.
• Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
• Unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
• Known hypersensitivity or allergy to the active pharmaceutical ingredients or any component of the study intervention formulations.
• Received colony-stimulating factors \[eg, granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GMCSF) or recombinant erythropoietin (EPO)\] within 28 days before randomization.
• Prior treatment with belzutifan or another hypoxia-inducible factor (HIF)-2α inhibitor.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Eisai Inc.: collaborator

Study Sites (184)

Ironwood Cancer & Research Centers ( Site 0077)

Chandler, Arizona, 85224, United States

Location

Cedars Sinai Medical Center ( Site 0027)

Los Angeles, California, 90048, United States

Location

UCLA Hematology/Oncology - Santa Monica ( Site 0048)

Los Angeles, California, 90404, United States

Location

St. Joseph Hospital-The Center for Cancer Prevention and Treatment ( Site 0095)

Orange, California, 92868, United States

Location

University of California, Irvine ( Site 0029)

Orange, California, 92868, United States

Location

Providence Saint John's Health Center ( Site 0083)

Santa Monica, California, 90404, United States

Location

Georgetown University Medical Center ( Site 0006)

Washington D.C., District of Columbia, 20007, United States

Location

AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlandoc ( Site 0003)

Orlando, Florida, 32804, United States

Location

Orlando Health, Inc. ( Site 0035)

Orlando, Florida, 32806, United States

Location

University Cancer & Blood Center, LLC ( Site 0057)

Athens, Georgia, 30607, United States

Location

Emory University Hospital ( Site 0012)

Atlanta, Georgia, 30322, United States

Location

Rush University Medical Center ( Site 0040)

Chicago, Illinois, 60607, United States

Location

Illinois Cancer Care, PC ( Site 0008)

Peoria, Illinois, 61615, United States

Location

Parkview Cancer Institute ( Site 0088)

Fort Wayne, Indiana, 46845, United States

Location

Norton Cancer Institute - St. Matthews ( Site 0065)

Louisville, Kentucky, 40207, United States

Location

Tulane University School of Medicine ( Site 0098)

New Orleans, Louisiana, 70112, United States

Location

Lahey Hospital & Medical Center ( Site 0090)

Burlington, Massachusetts, 01805, United States

Location

Cancer & Hematology Centers of Western Michigan ( Site 0018)

Grand Rapids, Michigan, 49503, United States

Location

HealthPartners Cancer Research Center-HealthPartners Frauenshuh Cancer Center ( Site 0005)

Saint Louis Park, Minnesota, 55426, United States

Location

University of Mississippi Medical Ctr ( Site 0037)

Jackson, Mississippi, 39213, United States

Location

Cancer Partners of Nebraska ( Site 0086)

Lincoln, Nebraska, 68516, United States

Location

Rutgers Cancer Institute of New Jersey ( Site 0078)

New Brunswick, New Jersey, 08903, United States

Location

R.J. Zuckerberg Cancer Center-Medical Oncology ( Site 0013)

Lake Success, New York, 11042, United States

Location

Memorial Sloan Kettering Cancer Center ( Site 0055)

New York, New York, 10065, United States

Location

Levine Cancer Institute ( Site 0004)

Charlotte, North Carolina, 28204, United States

Location

Duke Cancer Institute ( Site 0096)

Durham, North Carolina, 27710, United States

Location

Lehigh Valley Hospital- Cedar Crest-Oncology Clinical Trials ( Site 0056)

Allentown, Pennsylvania, 18103, United States

Location

University of Texas, Southwestern Medical Center ( Site 0015)

Dallas, Texas, 75235, United States

Location

Huntsman Cancer Institute-HCI Clinical Trials Office ( Site 7001)

Salt Lake City, Utah, 84112, United States

Location

University of Vermont Medical Center ( Site 0001)

Burlington, Vermont, 05401, United States

Location

Blue Ridge Cancer Care - Roanoke ( Site 0043)

Roanoke, Virginia, 24014, United States

Location

Seattle Cancer Care Alliance-Renal/Melanoma/MCC ( Site 0093)

Seattle, Washington, 98109, United States

Location

Central Washington Health Services Association d/b/a Confluence Health ( Site 0061)

Wenatchee, Washington, 98801, United States

Location

Centro de Urología (CDU) ( Site 0803)

CABA, Buenos Aires, C1120AAT, Argentina

Location

Hospital Británico de Buenos Aires-Oncology ( Site 0801)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB, Argentina

Location

Instituto Alexander Fleming ( Site 0800)

Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

Location

Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)

Buenos Aires, Buenos Aires F.D., C1419AHN, Argentina

Location

Sanatorio Británico-Clinical Oncology Department ( Site 0802)

Rosario, Santa Fe Province, 2000, Argentina

Location

Sanatorio Parque ( Site 0806)

Rosario, Santa Fe Province, S2000DSV, Argentina

Location

GenesisCare North Shore ( Site 4011)

St Leonards, New South Wales, 2065, Australia

Location

Lyell McEwin Hospital ( Site 4004)

Elizabeth Vale, South Australia, 5112, Australia

Location

Peninsula Health Frankston Hospital ( Site 4001)

Frankston, Victoria, 3199, Australia

Location

Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 4010)

Melbourne, Victoria, 3000, Australia

Location

Klinik Ottakring-1.Medizinische Abteilung - Zentrum für Onkologie und Hämatologie ( Site 1031)

Vienna, State of Vienna, 1160, Austria

Location

Medizinische Universitätsklinik Graz ( Site 1051)

Graz, Styria, 8036, Austria

Location

Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)

Linz, Upper Austria, 4020, Austria

Location

Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)

Vienna, 1020, Austria

Location

Medizinische Universität Wien ( Site 1021)

Vienna, 1090, Austria

Location

Institut Jules Bordet ( Site 1103)

Anderlecht, Bruxelles-Capitale, Region de, 1070, Belgium

Location

Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)

Brussels, Bruxelles-Capitale, Region de, 1200, Belgium

Location

Grand Hopital de Charleroi ( Site 1104)

Gilly, Hainaut, 6060, Belgium

Location

UZ Gent ( Site 1100)

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

UZ Leuven ( Site 1101)

Leuven, Vlaams-Brabant, 3000, Belgium

Location

CHU de Liege ( Site 1102)

Liège, 4000, Belgium

Location

Liga Norte Riograndense Contra o Cancer ( Site 0313)

Natal, Rio Grande do Norte, 59151600, Brazil

Location

Centro Gaucho Integrado de Oncologia ( Site 0304)

Porto Alegre, Rio Grande do Sul, 90110-270, Brazil

Location

BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0311)

São Paulo, 01321-001, Brazil

Location

Hospital Paulistano - Amil Clinical Research ( Site 0308)

São Paulo, 01321-001, Brazil

Location

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0109)

Calgary, Alberta, T2N 5G2, Canada

Location

Cross Cancer Institute ( Site 0111)

Edmonton, Alberta, T6G 1Z2, Canada

Location

BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)

Vancouver, British Columbia, V5Z 4E6, Canada

Location

The Moncton Hospital ( Site 0101)

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre ( Site 0105)

Kingston, Ontario, K7L 2V7, Canada

Location

The Ottawa Hospital - General Campus-The Ottawa Hospital Cancer Centre ( Site 0116)

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)

Toronto, Ontario, M4N 3M5, Canada

Location

CISSS de la Monteregie-Centre ( Site 0103)

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0115)

Québec, Quebec, G1J 1Z4, Canada

Location

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0102)

Sherbrooke, Quebec, J1H 5N4, Canada

Location

James Lind Centro de Investigacion del Cancer ( Site 0402)

Temuco, Araucania, 4800827, Chile

Location

Bradfordhill-Clinical Area ( Site 0400)

Santiago, Region M. de Santiago, 8420383, Chile

Location

Fundacion Colombiana de Cancerología Clinica Vida ( Site 0505)

Medellín, Antioquia, 050030, Colombia

Location

Sociedad De Oncologia Y Hematologia Del Cesar-Oncology ( Site 0508)

Valledupar, Cesar Department, 200001, Colombia

Location

Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)

Bogotá, Cundinamarca, 111511, Colombia

Location

Fundación Cardiovascular de Colombia ( Site 0501)

Piedecuesta, Santander Department, 681017, Colombia

Location

Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 2203)

Brno, Brno-mesto, 656 53, Czechia

Location

Fakultni Thomayerova nemocnice-Onkologicka klinika 1. LF UK ( Site 2200)

Prague, Praha 4, 140 59, Czechia

Location

Fakultni nemocnice v Motole-Onkologicka klinika 2. LF UK a FN Motol ( Site 2205)

Prague, Praha 5, 150 06, Czechia

Location

Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 2204)

České Budějovice, South Bohemian Region, 37001, Czechia

Location

Fakultni nemocnice Hradec Kralove-Klinika onkologie a radioterapie ( Site 2201)

Hradec Králové, 500 05, Czechia

Location

Tampereen yliopistollinen sairaala ( Site 1801)

Tampere, Pirkanmaa, 33520, Finland

Location

TYKS ( Site 1802)

Turku, Southwest Finland, 20520, Finland

Location

HYKS ( Site 1800)

Helsinki, Uusimaa, 00290, Finland

Location

Institut Jean Godinot ( Site 1216)

Reims, Ain, 51726, France

Location

Centre Antoine Lacassagne ( Site 1217)

Nice, Alpes-Maritimes, 06189, France

Location

Hopitaux Universitaires de Strasbourg- Hopital de Hautepierre ( Site 1218)

Strasbourg, Bas-Rhin, 67200, France

Location

CHU de Bordeaux- Hopital Saint Andre ( Site 1209)

Bordeaux, Gironde, 33000, France

Location

Institut Claudius Regaud ( Site 1215)

Toulouse, Haute-Garonne, 31059, France

Location

Clinique Francois Chenieux ( Site 1210)

Limoges, Haute-Vienne, 87039, France

Location

Institut de Cancerologie de l Ouest Centre Rene Gauducheau ( Site 1201)

Saint-Herblain, Loire-Atlantique, 44805, France

Location

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 1200)

Angers, Maine-et-Loire, 49055, France

Location

Hopital Tenon ( Site 1213)

Paris, 75020, France

Location

Klinik fuer Urologie ( Site 1303)

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

NCT-Department of Medical Oncology ( Site 1320)

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Klinikum Nuernberg Nord ( Site 1300)

Nuremberg, Bavaria, 90419, Germany

Location

Universitaetsklinikum Frankfurt ( Site 1301)

Frankfurt am Main, Hesse, 60590, Germany

Location

Universitaetsklinikum Aachen AOER ( Site 1317)

Aachen, North Rhine-Westphalia, 52074, Germany

Location

Universitaetsklinikum des Saarlandes ( Site 1305)

Homburg/ Saar, Saarland, 66421, Germany

Location

Krankenhaus Martha Maria Halle-Doelau ( Site 1314)

Halle, Saxony-Anhalt, 06120, Germany

Location

Helios Klinikum Erfurt GmbH ( Site 1315)

Erfurt, Thuringia, 99089, Germany

Location

Charite Universitaetsmedizin Berlin ( Site 1321)

Berlin, 10117, Germany

Location

HELIOS Klinikum Berlin-Buch ( Site 1311)

Berlin, 13125, Germany

Location

UNIVERSITY HOSPITAL OF PATRAS-DIVISION OF ONCOLOGY ( Site 3302)

Pátrai, Achaia, 26504, Greece

Location

Alexandra General Hospital of Athens-ONCOLOGY DEPT. ( Site 3304)

Athens, Attica, 115 28, Greece

Location

Athens Medical Center ( Site 3303)

Athens, Attica, 151 25, Greece

Location

ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)

Chaïdári, Attica, 124 62, Greece

Location

European Interbalkan Medical Center-Oncology Department ( Site 3300)

Thessaloniki, 570 01, Greece

Location

Mater Misericordiae University Hospital ( Site 3201)

Dublin, D07 R2WY, Ireland

Location

Mater Private Hospital - Dublin ( Site 3202)

Dublin, D07 R2WY, Ireland

Location

Tallaght University Hospital ( Site 3200)

Dublin, D24NR0A, Ireland

Location

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 1407)

Meldola, Forli-Cesena, 47014, Italy

Location

Istituto Clinico Humanitas Research Hospital ( Site 1406)

Rozzano, Milano, 20089, Italy

Location

Ospedale San Luigi Gonzaga ( Site 1405)

Orbassano, Torino, 10043, Italy

Location

Medical Oncology Ospedale San Donato ( Site 1404)

Arezzo, 52100, Italy

Location

Azienda Ospedaliera Policlinico di Bari ( Site 1402)

Bari, 70124, Italy

Location

IRCCS Ospedale San Raffaele ( Site 1409)

Milan, 20132, Italy

Location

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1400)

Milan, 20133, Italy

Location

Istituti Clinici Scientifici Maugeri Spa ( Site 1403)

Pavia, 27100, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli-Medical Oncology ( Site 1410)

Roma, 00168, Italy

Location

Azienda Ospedaliera S. Maria di Terni ( Site 1401)

Terni, 05100, Italy

Location

Ospedale Maggiore Borgo Trento ( Site 1408)

Verona, 37126, Italy

Location

Fujita Health University Hospital ( Site 5003)

Toyoake, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East ( Site 5000)

Kashiwa, Chiba, 2778577, Japan

Location

Toho University Sakura Medical Center ( Site 5014)

Sakura, Chiba, 285-8741, Japan

Location

Sapporo Medical University Hospital ( Site 5008)

Sapporo, Hokkaido, 060-8543, Japan

Location

Kobe City Medical Center General Hospital ( Site 5017)

Kobe, Hyōgo, 650-0047, Japan

Location

Yokohama City University Hospital ( Site 5007)

Yokohama, Kanagawa, 236-0004, Japan

Location

Nara Medical University Hospital ( Site 5002)

Kashihara, Nara, 634-0813, Japan

Location

Kindai University Hospital ( Site 5010)

Sakai, Osaka, 590-0197, Japan

Location

The University of Osaka Hospital ( Site 5012)

Suita, Osaka, 565-0871, Japan

Location

Hamamatsu University Hospital ( Site 5004)

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Institute of Science Tokyo Hospital ( Site 5009)

Bunkyo-ku, Tokyo, 113-8510, Japan

Location

Toranomon Hospital ( Site 5001)

Minato-ku, Tokyo, 105-8470, Japan

Location

Kyushu University Hospital ( Site 5005)

Fukuoka, 812-8582, Japan

Location

Niigata University Medical & Dental Hospital ( Site 5013)

Niigata, 951-8520, Japan

Location

Osaka Prefectural Hospital Organization Osaka International Cancer Institute ( Site 5016)

Osaka, 541-8567, Japan

Location

Nippon Medical School Hospital ( Site 5006)

Tokyo, 113-8603, Japan

Location

Tokyo Women's Medical University Adachi Medical Center ( Site 5015)

Tokyo, 123-8558, Japan

Location

Keio University Hospital ( Site 5011)

Tokyo, 160-8582, Japan

Location

Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)

Sittard-Geleen, Limburg, 6162 BG, Netherlands

Location

Amphia Hospital Location Molengracht ( Site 1912)

Breda, North Brabant, 4818 CK, Netherlands

Location

Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Medisch Centrum Leeuwarden ( Site 1905)

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

Location

Erasmus MC ( Site 1913)

Rotterdam, South Holland, 3015 GD, Netherlands

Location

Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)

Schiedam, South Holland, 3118 JH, Netherlands

Location

Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)

The Hague, South Holland, 2545 AA, Netherlands

Location

Universitair Medisch Centrum Utrecht ( Site 1910)

Utrecht, 3584 CX, Netherlands

Location

Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)

Poznan, Greater Poland Voivodeship, 60-569, Poland

Location

Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2402)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - O-Klinika Onkologii Klinicznej ( Site 2403)

Krakow, Lesser Poland Voivodeship, 31-115, Poland

Location

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2400)

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2500)

Cluj-Napoca, Cluj, 400015, Romania

Location

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 2501)

Cluj-Napoca, Cluj, 400015, Romania

Location

Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)

Craiova, Dolj, 200542, Romania

Location

Ivanovo Regional Oncology Dispensary ( Site 2616)

Ivanovo, Ivanovo Oblast, 153040, Russia

Location

FSBI United Hospital with Polyclinic ( Site 2613)

Moscow, Moscow, 119285, Russia

Location

SHI of Moscow City Oncology Clinical Hospital - 62 ( Site 2614)

Moscow, Moscow, 125130, Russia

Location

MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 2618)

Krasnogorsk, Moscow Oblast, 143442, Russia

Location

Hadassah Medical-Oncology department ( Site 2609)

Moscow, Moscow Oblast, 121205, Russia

Location

Volgograd Regional Uronephrological Center ( Site 2615)

Volzhsky, Volgograd Oblast, 404120, Russia

Location

Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

Chonnam National University Hwasun Hospital-Oncology ( Site 4203)

Hwasun, Jeonranamdo, 58128, South Korea

Location

Asan Medical Center ( Site 4200)

Seoul, 05505, South Korea

Location

Samsung Medical Center ( Site 4201)

Seoul, 06351, South Korea

Location

Complejo Hospitalario Universitario A Coruna ( Site 1502)

A Coruña, La Coruna, 15006, Spain

Location

Hospital Universitario 12 de Octubre-Medical Oncology ( Site 1508)

Madrid, Madrid, Comunidad de, 28041, Spain

Location

Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 1507)

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial ( Site 1500)

Barcelona, 08036, Spain

Location

Hospital Santa Creu i Sant Pau ( Site 1501)

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Maranon ( Site 1505)

Madrid, 28009, Spain

Location

Hospital Clinico San Carlos... ( Site 1504)

Madrid, 28040, Spain

Location

Hospital Virgen del Rocio ( Site 1503)

Seville, 41013, Spain

Location

Hopitaux Universitaires de Geneve HUG ( Site 1602)

Geneva, Canton of Geneva, 1211, Switzerland

Location

Universitaetsspital Zuerich ( Site 1601)

Zurich, Canton of Zurich, 8001, Switzerland

Location

Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1604)

Bellinzona, Canton Ticino, 6500, Switzerland

Location

Kantonsspital Graubuenden ( Site 1600)

Chur, Kanton Graubünden, 7000, Switzerland

Location

Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Royal United Hospital Bath England ( Site 3108)

Bath, Bath And North East Somerset, BA1 3NG, United Kingdom

Location

Nottingham University Hospitals NHS Trust. City Hospital Campus ( Site 3106)

Nottingham, England, NG5 1PF, United Kingdom

Location

Southend University Hospital ( Site 3112)

Southend, Essex, SS0 0RY, United Kingdom

Location

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)

London, London, City of, W6 8RF, United Kingdom

Location

Mount Vernon Cancer Centre ( Site 3101)

Northwood, London, City of, HA6 2RN, United Kingdom

Location

Musgrove Park Hospital ( Site 3103)

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Singleton Hospital ( Site 3111)

Swansea, Wales, SA2 8QA, United Kingdom

Location

Related Publications (1)

• Motzer RJ, Schmidinger M, Eto M, Suarez C, Figlin R, Liu Y, Perini R, Zhang Y, Heng DY. LITESPARK-011: belzutifan plus lenvatinib vs cabozantinib in advanced renal cell carcinoma after anti-PD-1/PD-L1 therapy. Future Oncol. 2023 Jan;19(2):113-121. doi: 10.2217/fon-2022-0802. Epub 2023 Feb 8.

  PMID: 36752726 DERIVED

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

belzutifan; lenvatinib; cabozantinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2020
• First Posted: October 14, 2020
• Study Start: February 25, 2021
• Primary Completion: February 2, 2026
• Study Completion (Estimated): February 11, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (11); GR (5); IE (3); FI (3); RO (3); GB (8); CZ (5); CO (4); BE (6); JP (18); NL (8); US (33); CH (4); CA (11); ES (8); AR (6); DE (10); AU (5); CL (2); PL (4); RU (7); BR (4); FR (9); KR (3)