AzTrials
AzTrials

Carcinoma, Renal CellPhase 3NCT04586231

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

A Phase 3 study testing Belzutifan, Lenvatinib and Cabozantinib in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 184 sites in 25 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carcinoma, Renal Cell
What is being tested?
Belzutifan, Lenvatinib and Cabozantinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
747 participants
Where
184 sitesin 25 countries
Study dates
25 Feb 2021to 11 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 Response Evaluation Criteria in Solid Tumors (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
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  • 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

Who cannot join

  • 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 corrected QT interval (QTc) interval to >480 ms.
  • Symptomatic pleural effusion (e.g.,cough, dyspnea, pleuritic chest pain) that is not clinically stable
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  • 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
  • Prior treatment with lenvatinib
  • Prior treatment with cabozantinib
  • Currently participating in a study of an investigational agent or using an investigational device
  • Active infection requiring systemic therapy
  • History of human immunodeficiency virus (HIV) infection
  • History of hepatitis B or known active hepatitis C infection

Trial locations and contacts

184 sites in 25 countries.

184 sites in 25 countries

United States33 sites

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

    Allentown, Pennsylvania, 18103

  • University Cancer & Blood Center, LLC ( Site 0057)

    Athens, Georgia, 30607

  • Emory University Hospital ( Site 0012)

    Atlanta, Georgia, 30322

  • Lahey Hospital & Medical Center ( Site 0090)

    Burlington, Massachusetts, 01805

  • University of Vermont Medical Center ( Site 0001)

    Burlington, Vermont, 05401

  • Ironwood Cancer & Research Centers ( Site 0077)

    Chandler, Arizona, 85224

  • Levine Cancer Institute ( Site 0004)

    Charlotte, North Carolina, 28204

  • Rush University Medical Center ( Site 0040)

    Chicago, Illinois, 60607

  • University of Texas, Southwestern Medical Center ( Site 0015)

    Dallas, Texas, 75235

  • Duke Cancer Institute ( Site 0096)

    Durham, North Carolina, 27710

  • Parkview Cancer Institute ( Site 0088)

    Fort Wayne, Indiana, 46845

  • Cancer & Hematology Centers of Western Michigan ( Site 0018)

    Grand Rapids, Michigan, 49503

  • University of Mississippi Medical Ctr ( Site 0037)

    Jackson, Mississippi, 39213

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

    Lake Success, New York, 11042

  • Cancer Partners of Nebraska ( Site 0086)

    Lincoln, Nebraska, 68516

  • Cedars Sinai Medical Center ( Site 0027)

    Los Angeles, California, 90048

  • UCLA Hematology/Oncology - Santa Monica ( Site 0048)

    Los Angeles, California, 90404

  • Norton Cancer Institute - St. Matthews ( Site 0065)

    Louisville, Kentucky, 40207

  • Rutgers Cancer Institute of New Jersey ( Site 0078)

    New Brunswick, New Jersey, 08903

  • Tulane University School of Medicine ( Site 0098)

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center ( Site 0055)

    New York, New York, 10065

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

    Orange, California, 92868

  • University of California, Irvine ( Site 0029)

    Orange, California, 92868

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

    Orlando, Florida, 32804

  • Orlando Health, Inc. ( Site 0035)

    Orlando, Florida, 32806

  • Illinois Cancer Care, PC ( Site 0008)

    Peoria, Illinois, 61615

  • Blue Ridge Cancer Care - Roanoke ( Site 0043)

    Roanoke, Virginia, 24014

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

    Saint Louis Park, Minnesota, 55426

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

    Salt Lake City, Utah, 84112

  • Providence Saint John's Health Center ( Site 0083)

    Santa Monica, California, 90404

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

    Seattle, Washington, 98109

  • Georgetown University Medical Center ( Site 0006)

    Washington D.C., District of Columbia, 20007

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

    Wenatchee, Washington, 98801

Other trials in United States

Japan18 sites

  • Institute of Science Tokyo Hospital ( Site 5009)

    Bunkyo-ku, Tokyo, 113-8510

  • Kyushu University Hospital ( Site 5005)

    Fukuoka, 812-8582

  • Hamamatsu University Hospital ( Site 5004)

    Hamamatsu, Shizuoka, 431-3192

  • Nara Medical University Hospital ( Site 5002)

    Kashihara, Nara, 634-0813

  • National Cancer Center Hospital East ( Site 5000)

    Kashiwa, Chiba, 2778577

  • Kobe City Medical Center General Hospital ( Site 5017)

    Kobe, Hyōgo, 650-0047

  • Toranomon Hospital ( Site 5001)

    Minato-ku, Tokyo, 105-8470

  • Niigata University Medical & Dental Hospital ( Site 5013)

    Niigata, 951-8520

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

    Osaka, 541-8567

  • Kindai University Hospital ( Site 5010)

    Sakai, Osaka, 590-0197

  • Toho University Sakura Medical Center ( Site 5014)

    Sakura, Chiba, 285-8741

  • Sapporo Medical University Hospital ( Site 5008)

    Sapporo, Hokkaido, 060-8543

  • The University of Osaka Hospital ( Site 5012)

    Suita, Osaka, 565-0871

  • Nippon Medical School Hospital ( Site 5006)

    Tokyo, 113-8603

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

    Tokyo, 123-8558

  • Keio University Hospital ( Site 5011)

    Tokyo, 160-8582

  • Fujita Health University Hospital ( Site 5003)

    Toyoake, Aichi-ken, 470-1192

  • Yokohama City University Hospital ( Site 5007)

    Yokohama, Kanagawa, 236-0004

Other trials in Japan

Canada11 sites

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

    Calgary, Alberta, T2N 5G2

  • Cross Cancer Institute ( Site 0111)

    Edmonton, Alberta, T6G 1Z2

  • CISSS de la Monteregie-Centre ( Site 0103)

    Greenfield Park, Quebec, J4V 2H1

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0114)

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre ( Site 0105)

    Kingston, Ontario, K7L 2V7

  • The Moncton Hospital ( Site 0101)

    Moncton, New Brunswick, E1C 6Z8

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

    Ottawa, Ontario, K1H 8L6

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

    Québec, Quebec, G1J 1Z4

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

    Sherbrooke, Quebec, J1H 5N4

  • Sunnybrook Health Sciences - Odette Cancer Centre ( Site 0113)

    Toronto, Ontario, M4N 3M5

  • BC Cancer Vancouver-Clinical Trials Unit ( Site 0110)

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy11 sites

  • Medical Oncology Ospedale San Donato ( Site 1404)

    Arezzo, 52100

  • Azienda Ospedaliera Policlinico di Bari ( Site 1402)

    Bari, 70124

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

    Meldola, Forli-Cesena, 47014

  • IRCCS Ospedale San Raffaele ( Site 1409)

    Milan, 20132

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

    Milan, 20133

  • Ospedale San Luigi Gonzaga ( Site 1405)

    Orbassano, Torino, 10043

  • Istituti Clinici Scientifici Maugeri Spa ( Site 1403)

    Pavia, 27100

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

    Roma, 00168

  • Istituto Clinico Humanitas Research Hospital ( Site 1406)

    Rozzano, Milano, 20089

  • Azienda Ospedaliera S. Maria di Terni ( Site 1401)

    Terni, 05100

  • Ospedale Maggiore Borgo Trento ( Site 1408)

    Verona, 37126

Other trials in Italy

Germany10 sites

  • Universitaetsklinikum Aachen AOER ( Site 1317)

    Aachen, North Rhine-Westphalia, 52074

  • Charite Universitaetsmedizin Berlin ( Site 1321)

    Berlin, 10117

  • HELIOS Klinikum Berlin-Buch ( Site 1311)

    Berlin, 13125

  • Helios Klinikum Erfurt GmbH ( Site 1315)

    Erfurt, Thuringia, 99089

  • Universitaetsklinikum Frankfurt ( Site 1301)

    Frankfurt am Main, Hesse, 60590

  • Klinik fuer Urologie ( Site 1303)

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Krankenhaus Martha Maria Halle-Doelau ( Site 1314)

    Halle, Saxony-Anhalt, 06120

  • NCT-Department of Medical Oncology ( Site 1320)

    Heidelberg, Baden-Wurttemberg, 69120

  • Universitaetsklinikum des Saarlandes ( Site 1305)

    Homburg/ Saar, Saarland, 66421

  • Klinikum Nuernberg Nord ( Site 1300)

    Nuremberg, Bavaria, 90419

Other trials in Germany

France9 sites

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

    Angers, Maine-et-Loire, 49055

  • CHU de Bordeaux- Hopital Saint Andre ( Site 1209)

    Bordeaux, Gironde, 33000

  • Clinique Francois Chenieux ( Site 1210)

    Limoges, Haute-Vienne, 87039

  • Centre Antoine Lacassagne ( Site 1217)

    Nice, Alpes-Maritimes, 06189

  • Hopital Tenon ( Site 1213)

    Paris, 75020

  • Institut Jean Godinot ( Site 1216)

    Reims, Ain, 51726

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

    Saint-Herblain, Loire-Atlantique, 44805

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

    Strasbourg, Bas-Rhin, 67200

  • Institut Claudius Regaud ( Site 1215)

    Toulouse, Haute-Garonne, 31059

Other trials in France

Netherlands8 sites

  • Antoni van Leeuwenhoek Ziekenhuis ( Site 1901)

    Amsterdam, North Holland, 1066 CX

  • Amphia Hospital Location Molengracht ( Site 1912)

    Breda, North Brabant, 4818 CK

  • Medisch Centrum Leeuwarden ( Site 1905)

    Leeuwarden, Provincie Friesland, 8934 AD

  • Erasmus MC ( Site 1913)

    Rotterdam, South Holland, 3015 GD

  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1909)

    Schiedam, South Holland, 3118 JH

  • Zuyderland Medical Centre-Trialbureau Interne Geneeskunde ( Site 1904)

    Sittard-Geleen, Limburg, 6162 BG

  • Haga Ziekenhuis locatie Leyweg-Oncology ( Site 1917)

    The Hague, South Holland, 2545 AA

  • Universitair Medisch Centrum Utrecht ( Site 1910)

    Utrecht, 3584 CX

Other trials in Netherlands

Spain8 sites

  • Complejo Hospitalario Universitario A Coruna ( Site 1502)

    A Coruña, La Coruna, 15006

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

    Barcelona, 08035

  • Hospital Clinic i Provincial ( Site 1500)

    Barcelona, 08036

  • Hospital Santa Creu i Sant Pau ( Site 1501)

    Barcelona, 08041

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

    Madrid, Madrid, Comunidad de, 28041

  • Hospital General Universitario Gregorio Maranon ( Site 1505)

    Madrid, 28009

  • Hospital Clinico San Carlos... ( Site 1504)

    Madrid, 28040

  • Hospital Virgen del Rocio ( Site 1503)

    Seville, 41013

Other trials in Spain

United Kingdom8 sites

  • Aberdeen Royal Infirmary-Department of Oncology ( Site 3105)

    Aberdeen, Aberdeen City, AB25 2ZN

  • Royal United Hospital Bath England ( Site 3108)

    Bath, Bath And North East Somerset, BA1 3NG

  • Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 3107)

    London, London, City of, W6 8RF

  • Mount Vernon Cancer Centre ( Site 3101)

    Northwood, London, City of, HA6 2RN

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

    Nottingham, England, NG5 1PF

  • Southend University Hospital ( Site 3112)

    Southend, Essex, SS0 0RY

  • Singleton Hospital ( Site 3111)

    Swansea, Wales, SA2 8QA

  • Musgrove Park Hospital ( Site 3103)

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Russia7 sites

  • Ivanovo Regional Oncology Dispensary ( Site 2616)

    Ivanovo, Ivanovo Oblast, 153040

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

    Krasnogorsk, Moscow Oblast, 143442

  • FSBI United Hospital with Polyclinic ( Site 2613)

    Moscow, Moscow, 119285

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

    Moscow, Moscow, 125130

  • Hadassah Medical-Oncology department ( Site 2609)

    Moscow, Moscow Oblast, 121205

  • Volgograd Regional Uronephrological Center ( Site 2615)

    Volzhsky, Volgograd Oblast, 404120

  • Yaroslavl Regional Cancer Hospital-Oncology ( Site 2619)

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Argentina6 sites

  • Asociación de Beneficencia Hospital Sirio Libanés ( Site 0804)

    Buenos Aires, Buenos Aires F.D., C1419AHN

  • Centro de Urología (CDU) ( Site 0803)

    CABA, Buenos Aires, C1120AAT

  • Hospital Británico de Buenos Aires-Oncology ( Site 0801)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1280AEB

  • Instituto Alexander Fleming ( Site 0800)

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1426ANZ

  • Sanatorio Británico-Clinical Oncology Department ( Site 0802)

    Rosario, Santa Fe Province, 2000

  • Sanatorio Parque ( Site 0806)

    Rosario, Santa Fe Province, S2000DSV

Other trials in Argentina

Belgium6 sites

  • Institut Jules Bordet ( Site 1103)

    Anderlecht, Bruxelles-Capitale, Region de, 1070

  • Cliniques Universitaires Saint Luc - Bruxelles ( Site 1105)

    Brussels, Bruxelles-Capitale, Region de, 1200

  • UZ Gent ( Site 1100)

    Ghent, Oost-Vlaanderen, 9000

  • Grand Hopital de Charleroi ( Site 1104)

    Gilly, Hainaut, 6060

  • UZ Leuven ( Site 1101)

    Leuven, Vlaams-Brabant, 3000

  • CHU de Liege ( Site 1102)

    Liège, 4000

Other trials in Belgium

Austria5 sites

  • Medizinische Universitätsklinik Graz ( Site 1051)

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 1001)

    Linz, Upper Austria, 4020

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

    Vienna, State of Vienna, 1160

  • Krankenhaus der Barmherzigen Brüder Wien ( Site 1041)

    Vienna, 1020

  • Medizinische Universität Wien ( Site 1021)

    Vienna, 1090

Other trials in Austria

Czechia5 sites

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

    Brno, Brno-mesto, 656 53

  • Nemocnice Ceske Budejovice-Onkologicke oddeleni ( Site 2204)

    České Budějovice, South Bohemian Region, 37001

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

    Hradec Králové, 500 05

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

    Prague, Praha 4, 140 59

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

    Prague, Praha 5, 150 06

Other trials in Czechia

Greece5 sites

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

    Athens, Attica, 115 28

  • Athens Medical Center ( Site 3303)

    Athens, Attica, 151 25

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 3301)

    Chaïdári, Attica, 124 62

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

    Pátrai, Achaia, 26504

  • European Interbalkan Medical Center-Oncology Department ( Site 3300)

    Thessaloniki, 570 01

Other trials in Greece

Australia4 sites

  • Lyell McEwin Hospital ( Site 4004)

    Elizabeth Vale, South Australia, 5112

  • Peninsula Health Frankston Hospital ( Site 4001)

    Frankston, Victoria, 3199

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

    Melbourne, Victoria, 3000

  • GenesisCare North Shore ( Site 4011)

    St Leonards, New South Wales, 2065

Other trials in Australia

Brazil4 sites

  • Liga Norte Riograndense Contra o Cancer ( Site 0313)

    Natal, Rio Grande do Norte, 59151600

  • Centro Gaucho Integrado de Oncologia ( Site 0304)

    Porto Alegre, Rio Grande do Sul, 90110-270

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

    São Paulo, 01321-001

  • Hospital Paulistano - Amil Clinical Research ( Site 0308)

    São Paulo, 01321-001

Other trials in Brazil

Colombia4 sites

  • Instituto Nacional de Cancerología-Clinical Oncology ( Site 0500)

    Bogotá, Cundinamarca, 111511

  • Fundacion Colombiana de Cancerología Clinica Vida ( Site 0505)

    Medellín, Antioquia, 050030

  • Fundación Cardiovascular de Colombia ( Site 0501)

    Piedecuesta, Santander Department, 681017

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

    Valledupar, Cesar Department, 200001

Other trials in Colombia

Poland4 sites

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

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Krakow, Lesser Poland Voivodeship, 31-115

  • Uniwersytecki Szpital Kliniczny w Poznaniu ( Site 2401)

    Poznan, Greater Poland Voivodeship, 60-569

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

    Warsaw, Masovian Voivodeship, 02-781

Other trials in Poland

Switzerland4 sites

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

    Bellinzona, Canton Ticino, 6500

  • Kantonsspital Graubuenden ( Site 1600)

    Chur, Kanton Graubünden, 7000

  • Hopitaux Universitaires de Geneve HUG ( Site 1602)

    Geneva, Canton of Geneva, 1211

  • Universitaetsspital Zuerich ( Site 1601)

    Zurich, Canton of Zurich, 8001

Other trials in Switzerland

Finland3 sites

  • HYKS ( Site 1800)

    Helsinki, Uusimaa, 00290

  • Tampereen yliopistollinen sairaala ( Site 1801)

    Tampere, Pirkanmaa, 33520

  • TYKS ( Site 1802)

    Turku, Southwest Finland, 20520

Other trials in Finland

Ireland3 sites

  • Mater Misericordiae University Hospital ( Site 3201)

    Dublin, D07 R2WY

  • Mater Private Hospital - Dublin ( Site 3202)

    Dublin, D07 R2WY

  • Tallaght University Hospital ( Site 3200)

    Dublin, D24NR0A

Other trials in Ireland

Romania3 sites

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

    Cluj-Napoca, Cluj, 400015

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

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie "Sfântul Nectarie" ( Site 2502)

    Craiova, Dolj, 200542

Other trials in Romania

South Korea3 sites

  • Chonnam National University Hwasun Hospital-Oncology ( Site 4203)

    Hwasun, Jeonranamdo, 58128

  • Asan Medical Center ( Site 4200)

    Seoul, 05505

  • Samsung Medical Center ( Site 4201)

    Seoul, 06351

Other trials in South Korea

Chile2 sites

  • Bradfordhill-Clinical Area ( Site 0400)

    Santiago, Region M. de Santiago, 8420383

  • James Lind Centro de Investigacion del Cancer ( Site 0402)

    Temuco, Araucania, 4800827

Other trials in Chile

About this study

Official title: An Open-label, Randomized, Phase 3 Study of MK-6482 in Combination With Lenvatinib (MK-7902) vs Cabozantinib for Treatment in Participants With Advanced Renal Cell Carcinoma Who Have Progressed After Prior Anti-PD-1/L1 Therapy

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.

Being tested
Belzutifan, Lenvatinib, Cabozantinib
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BelzutifanDrug

    Also called PT2977, MK-6482, WELIREG™

    Oral administration

  • LenvatinibDrug

    Also called Lenvima, E7080, MK-7902

    Oral administration

  • CabozantinibDrug

    Also called Cabometyx, Cometriq, XL184, BMS-907351

    Oral administration

Study groups in NCT04586231
Study groupRoleWhat they receive
Belzutifan + LenvatinibExperimentalParticipants received daily oral dose of belzutifan 120 mg and lenvatinib 20 mg until progressive disease or discontinuation.
Receives: Drug: Belzutifan; Drug: Lenvatinib
CabozantinibActive comparatorParticipants received daily oral dose of cabozantinib 60 mg until progressive disease or discontinuation.
Receives: Drug: Cabozantinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to approximately 34 months

  2. Overall Survival (OS)

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

    Measured: Up to approximately 44 months

Secondary outcomes (4)

  1. 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)

    ORR is defined as the percentage of participants who have a complete response (CR: Disappearance of all target lesions) or a partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience a CR or PR as assessed by blinded independent central review based on RECIST 1.1 will be presented.

    Measured: Up to approximately 24 months

  2. 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)

    For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed partial response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death. The DOR as assessed by blinded independent central review will be presented.

    Measured: Up to approximately 44 months

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

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 44 months

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

    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

    Measured: Up to approximately 44 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study start25 Feb 2021
  3. Primary completion2 Feb 2026
  4. Study completion11 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
747 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586231
Sponsor's protocol ID
6482-011
Other IDs
MK-6482-011, jRCT2031210311, 2024-510620-39-00, U1111-1302-2815, 2020-002075-35
Status last verified
Nov 2026
First submitted
9 Oct 2020
Last updated
6 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Motzer RJ, McDermott R, Park SH, Burotto M, Iacovelli R, Verzoni E, Suarez C, Eto M, Cutuli HJ, Porta C, Kopp RM, Rottey S, Velasco G, Valderrama BP, Azad AA, Giorgi U, Pavic M, Tomczak P, Figlin R, Westgeest HM, Guida A, Necchi A, Schutz FA, Suelmann BBM, Haanen JBAG, Yuan SS, Perini RF, Wang D, Heng DYC, Schmidinger M; LITESPARK-011 Investigators. Belzutifan plus lenvatinib versus cabozantinib in patients with previously treated advanced renal cell carcinoma (LITESPARK-011): an open-label, randomised, controlled, phase 3 trial. Lancet. 2026 Aug 12:S0140-6736(26)01089-5. doi: 10.1016/S0140-6736(26)01089-5. Online ahead of print.

    PubMed 42586114

  • Heng DYC, Schmidinger M, McDermott R, Park SH, Burotto M, Ciccarese C, Verzoni E, Suarez C, Eto M, Cutuli HJ, Porta C, Kopp RM, Rottey S, de Velasco G, Valderrama BP, Azad AA, De Giorgi U, Pavic M, Tomczak P, Figlin R, Westgeest HM, Guida A, Necchi A, Schutz FA, Suelmann BBM, Haanen JB, Lin J, Perini RF, Vickery D, Motzer RJ; LITESPARK-011 Investigators. Final prespecified analysis of the phase 3 LITESPARK-011 study: belzutifan plus lenvatinib versus cabozantinib for advanced renal cell carcinoma after anti-PD-(L)1 therapy. Ann Oncol. 2026 Oct 25:S0923-7534(26)06893-6. doi: 10.1016/j.annonc.2026.10.109. Online ahead of print.

    PubMed 42927855

  • 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.

    PubMed 36752726

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Belzutifan, Lenvatinib and Cabozantinib in people with Carcinoma, Renal Cell, run by Merck Sharp & Dohme LLC at 184 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 184 sites in United States, Japan, Canada, Italy, Germany and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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) (time frame: Up to approximately 34 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586231, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.

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