A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033) (LITESPARK-033)

May 8, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants With Advanced RCC Who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

Researchers are looking for more ways to treat advanced renal cell carcinoma (RCC) that is recurrent. Researchers want to learn if recurrent advanced renal cell carcinoma (RCC) responds (gets smaller or goes away) after treatment with belzutifan (MK-6482) and zanzalintinib compared to cabozantinib.

The goal of this study is to learn if:

People who take belzutifan and zanzalintinib live longer overall and without the cancer getting worse than people who take cabozantinib.

Study Overview

Status

Recruiting

Conditions

Renal Cell Carcinoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

904

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Toll Free Number
Phone Number: 1-888-577-8839
Email: Trialsites@msd.com

Study Locations

Argentina
- - Córdoba, Argentina, X5016KEH
    - Recruiting
    - Hospital Privado Universitario de Córdoba ( Site 0207)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +543514688200
- Buenos Aires
  - CABA, Buenos Aires, Argentina, C1426ANZ
    - Recruiting
    - Instituto Alexander Fleming ( Site 0202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541132218900
  - CABA, Buenos Aires, Argentina, C1118AAT
    - Recruiting
    - Hospital Aleman ( Site 0204)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5448277000
  - Caba, Buenos Aires, Argentina, C1419AHN
    - Recruiting
    - Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541145740870
  - Caba, Buenos Aires, Argentina, C1199ABB
    - Recruiting
    - Hospital Italiano de Buenos Aires. ( Site 0203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541149590200
- Buenos Aires F.D.
  - Caba., Buenos Aires F.D., Argentina, C1431FWO
    - Recruiting
    - Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +541152990000
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000KZE
    - Recruiting
    - Instituto de Oncología de Rosario ( Site 0209)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5493414218909
  - Rosario, Santa Fe Province, Argentina, S2000DSV
    - Recruiting
    - Sanatorio Parque ( Site 0201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5493416955611
Australia
- New South Wales
  - Sydney, New South Wales, Australia, 2109
    - Recruiting
    - Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +61 2 9812 3526
Austria
- - Vienna, Austria, 1090
    - Recruiting
    - Medizinische Universitat Wien ( Site 0601)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +43 1 40400 60430
- Upper Austria
  - Linz, Upper Austria, Austria, 4020
    - Recruiting
    - Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +43 732 7676 4641
Belgium
- Bruxelles-Capitale, Region de
  - Brussels, Bruxelles-Capitale, Region de, Belgium, 1200
    - Recruiting
    - Cliniques Universitaires Saint-Luc ( Site 0703)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +3227643546
- Limburg
  - Genk, Limburg, Belgium, 3600
    - Recruiting
    - Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +32 89 80 40 40
- Oost-Vlaanderen
  - Ghent, Oost-Vlaanderen, Belgium, 9000
    - Recruiting
    - UZ Gent ( Site 0702)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +32 (0)9 332 62 18
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - Recruiting
    - UZ Leuven ( Site 0700)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +32 (0)16 34 69 12
Brazil
- Mato Grosso
  - Cuiabá, Mato Grosso, Brazil, 78020-500
    - Recruiting
    - IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0305)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5565999470522
- Rio Grande do Norte
  - Natal, Rio Grande do Norte, Brazil, 59062-000
    - Recruiting
    - Liga Norte Riograndense Contra o Câncer ( Site 0307)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +558440095595
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
    - Recruiting
    - Hospital Moinhos de Vento ( Site 0309)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +5551980609999
- São Paulo
  - São José do Rio Preto, São Paulo, Brazil, 15090-000
    - Recruiting
    - Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +551732015000
  - São Paulo, São Paulo, Brazil, 01327-001
    - Recruiting
    - Hospital Alemao Oswaldo Cruz ( Site 0311)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +551135490391
Croatia
- Split-Dalmatia County
  - Split, Split-Dalmatia County, Croatia, 21000
    - Recruiting
    - Klinički Bolnički Centar Split ( Site 0802)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +385915297299
Czechia
- - Hradec Králové, Czechia, 500 05
    - Recruiting
    - Fakultni nemocnice Hradec Kralove ( Site 0902)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420 607 192 913
  - Olomouc, Czechia, 779 00
    - Recruiting
    - Fakultni nemocnice Olomouc ( Site 0901)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420588444295
  - Prague, Czechia, 150 06
    - Recruiting
    - Fakultni nemocnice v Motole ( Site 0900)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420224439427
  - Prague, Czechia, 128 08
    - Recruiting
    - Vseobecna fakultni nemocnice v Praze ( Site 0906)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420 224 966 405
  - České Budějovice, Czechia, 370 01
    - Recruiting
    - Nemocnice České Budějovice ( Site 0905)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420387871111
- Brno-mesto
  - Brno, Brno-mesto, Czechia, 656 53
    - Recruiting
    - Masarykuv onkologicky ustav ( Site 0903)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420543136831
- Ostrava Mesto
  - Ostrava, Ostrava Mesto, Czechia, 708 52
    - Recruiting
    - Fakultni nemocnice Ostrava ( Site 0904)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +420597374322
Denmark
- Capital Region
  - Herlev, Capital Region, Denmark, 2730
    - Recruiting
    - Herlev Hospital ( Site 1002)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +45 38688798
- Central Jutland
  - Aarhus, Central Jutland, Denmark, 8200
    - Recruiting
    - Aarhus University Hospital Skejby ( Site 1001)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +45 91167192
- Region Syddanmark
  - Odense, Region Syddanmark, Denmark, 9000
    - Recruiting
    - Odense Universitetshospital ( Site 1000)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +45 65411516
France
- Gironde
  - Bordeaux, Gironde, France, 33075
    - Recruiting
    - CHU de Bordeaux Hop St ANDRE ( Site 1115)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33556795679
- Hauts-de-Seine
  - Suresnes, Hauts-de-Seine, France, 92150
    - Recruiting
    - Hôpital Foch ( Site 1118)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33146253671
- Herault
  - Montpellier, Herault, France, 34070
    - Recruiting
    - Centre de Cancérologie du Grand Montpellier ( Site 1112)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33467926155
- Isere
  - La Tronche, Isere, France, 38700
    - Recruiting
    - CHU GRENOBLE ALPES ( Site 1101)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33476765451
- Lorraine
  - Nancy, Lorraine, France, 54100
    - Recruiting
    - Centre d'Oncologie de Gentilly ( Site 1117)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33355685518
- Pays de la Loire Region
  - Angers, Pays de la Loire Region, France, 49933
    - Recruiting
    - Centre Hospitalier Universitaire d'Angers-Urology ( Site 1104)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33665807200
- Pyrenees-Atlantiques
  - Bayonne, Pyrenees-Atlantiques, France, 64109
    - Recruiting
    - Centre Hospitalier de la Côte Basque ( Site 1113)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33559443535
- Rhone
  - Pierre-Bénite, Rhone, France, 69310
    - Recruiting
    - centre hospitalier lyon sud ( Site 1102)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33472118088
- Seine-Maritime
  - Rouen, Seine-Maritime, France, 76031
    - Recruiting
    - CHU de Rouen ( Site 1108)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33232881315
- Val-de-Marne
  - Créteil, Val-de-Marne, France, 94010
    - Recruiting
    - HENRI MONDOR HOSPITAL ( Site 1116)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33145178243
- Vendee
  - La Roche-sur-Yon, Vendee, France, 85000
    - Recruiting
    - CHD Vendee ( Site 1103)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +33251446173
Germany
- - Berlin, Germany, 10117
    - Recruiting
    - Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1203)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +49 30 45050
  - Hamburg, Germany, 20246
    - Recruiting
    - Universitaetsklinikum Hamburg-Eppendorf ( Site 1214)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +4915222823094
- Baden-Wurttemberg
  - Stuttgart, Baden-Wurttemberg, Germany, 70174
    - Recruiting
    - Klinikum Stuttgart - Katharinenhospital ( Site 1201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +49 7071 278 54564
  - Tübingen, Baden-Wurttemberg, Germany, 72076
    - Recruiting
    - UniversitaetsklInikum Tuebingen ( Site 1207)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 004970712987235
- Lower Saxony
  - Göttingen, Lower Saxony, Germany, 37075
    - Recruiting
    - Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1211)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +4955139 68145
- Mecklenburg-Vorpommern
  - Schwerin, Mecklenburg-Vorpommern, Germany, 19055
    - Recruiting
    - Helios Kliniken Schwerin GmbH ( Site 1206)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +493855202120
- North Rhine-Westphalia
  - Herne, North Rhine-Westphalia, Germany, 44625
    - Recruiting
    - Marienhospital Herne ( Site 1215)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +492323 4990
  - Münster, North Rhine-Westphalia, Germany, 70174
    - Recruiting
    - Universitaetsklinikum Muenster ( Site 1202)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +492518344658
- Saxony
  - Dresden, Saxony, Germany, 01307
    - Recruiting
    - Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +493514584425
- Thuringia
  - Erfurt, Thuringia, Germany, 99089
    - Recruiting
    - HELIOS Klinikum Erfurt ( Site 1208)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +493617810
  - Jena, Thuringia, Germany, 07747
    - Recruiting
    - Universitätsklinikum Jena ( Site 1204)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +4936419329901
Greece
- Attica
  - Athens, Attica, Greece, 185 47
    - Recruiting
    - Metropolitan Hospital ( Site 1302)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +302104809667
  - Athens, Attica, Greece, 115 28
    - Recruiting
    - Alexandra General Hospital of Athens ( Site 1300)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +302132162543
  - Chaïdári, Attica, Greece, 124 62
    - Recruiting
    - University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 1301)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +302105832549
Hong Kong
- - Hong Kong, Hong Kong
    - Recruiting
    - Queen Mary Hospital ( Site 2201)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +85222554361
  - Hong Kong, Hong Kong
    - Recruiting
    - Prince of Wales Hospital ( Site 2200)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +85235051042
Ireland
- - Cork, Ireland, T12 YK23
    - Recruiting
    - Cork University Hospital ( Site 1501)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +353214234802
  - Dublin, Ireland, D24 NR0A
    - Recruiting
    - Tallaght University Hospital ( Site 1500)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +35314144000
Italy
- - Arezzo, Italy, 52100
    - Recruiting
    - Azienda USL 8 di Arezzo ( Site 1605)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390575255446
  - Bari, Italy, 70124
    - Recruiting
    - A.O.U.C. Policlinico di Bari ( Site 1602)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390805592909
  - Bologna, Italy, 40138
    - Recruiting
    - IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1604)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390512142575
  - Genova, Italy, 16132
    - Recruiting
    - Ospedale San Martino ( Site 1606)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 003901015553303
- Campania
  - Naples, Campania, Italy, 80131
    - Recruiting
    - Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli ( Site 1609)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 00390817472223
- Lazio
  - Rome, Lazio, Italy, 00144
    - Recruiting
    - Istituto Nazionale Tumori Regina Elena ( Site 1611)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +39 0652666919
- Milano
  - Milan, Milano, Italy, 20133
    - Recruiting
    - Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 00390223903028
  - Rozzano, Milano, Italy, 20089
    - Recruiting
    - Istituto Clinico Humanitas ( Site 1613)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 00390282244061
- Piedmont
  - Orbassano, Piedmont, Italy, 10043
    - Recruiting
    - Azienda Ospedaliera S. Luigi Gonzaga ( Site 1607)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 00390119026534
- Roma
  - Rome, Roma, Italy, 00618
    - Recruiting
    - Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 00390630155202
- Tuscany
  - Florence, Tuscany, Italy, 50134
    - Recruiting
    - Azienda Ospedaliera Universitaria Careggi ( Site 1608)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390557949648
- Veneto
  - Peschiera del Garda, Veneto, Italy, 37019
    - Recruiting
    - Casa di Cura Dott. Pederzoli - UO Oncologia ( Site 1610)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +390456444193
Mexico
- - Mexico City, Mexico, 11810
    - Recruiting
    - Higiea Oncologia ( Site 0504)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +525652731712
  - Puebla City, Mexico, 72530
    - Recruiting
    - Clinica Integral Internacional de Oncología ( Site 0506)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +522229525806
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44630
    - Recruiting
    - CIO - Centro de Inmuno-Oncología de Occidente ( Site 0503)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 3331721132
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64710
    - Recruiting
    - I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 0507)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 8125558165 Ext. 1005
- Oaxaca
  - Oaxaca City, Oaxaca, Mexico, 68020
    - Recruiting
    - Centro de Investigacion Clinica de Oaxaca ( Site 0502)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +529516035559
Poland
- Greater Poland Voivodeship
  - Skórzewo, Greater Poland Voivodeship, Poland, 60-185
    - Recruiting
    - AIDPORT Sp. z o.o. ( Site 1716)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48570783100
- Kuyavian-Pomeranian Voivodeship
  - Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-796
    - Recruiting
    - Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1707)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48523743883
- Lesser Poland Voivodeship
  - Krakow, Lesser Poland Voivodeship, Poland, 30-727
    - Recruiting
    - Pratia MCM Krakow ( Site 1713)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48122958160
  - Krakow, Lesser Poland Voivodeship, Poland, 31-826
    - Recruiting
    - Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1703)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48126468251
- Masovian Voivodeship
  - Siedlce, Masovian Voivodeship, Poland, 08-110
    - Recruiting
    - Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1702)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48256403300
  - Warsaw, Masovian Voivodeship, Poland, 02-172
    - Recruiting
    - MTZ Clinical Research Powered by Pratia ( Site 1705)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48225725959
- Podkarpackie Voivodeship
  - Przemyśl, Podkarpackie Voivodeship, Poland, 37-700
    - Recruiting
    - Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1710)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +48166775511
- West Pomeranian Voivodeship
  - Koszalin, West Pomeranian Voivodeship, Poland, 75-581
    - Recruiting
    - Szpital Wojewodzki im. Mikolaja Kopernika w Koszalinie ( Site 1701)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 943488930
Singapore
- Central Singapore
  - Singapore, Central Singapore, Singapore, 168583
    - Recruiting
    - National Cancer Centre Singapore ( Site 2401)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +6564368000
  - Singapore, Central Singapore, Singapore, 119074
    - Recruiting
    - National University Hospital ( Site 2400)
    - Contact:
      
      Study Coordinator
      
      Phone Number: 6908 2222
South Korea
- - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center ( Site 2502)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82234101767
  - Seoul, South Korea, 03722
    - Recruiting
    - Severance Hospital, Yonsei University Health System ( Site 2503)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82222280430
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center ( Site 2501)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82230105977
- Jeonranamdo
  - Hwasun-gun, Jeonranamdo, South Korea, 58128
    - Recruiting
    - Chonnam National University Hwasun Hospital ( Site 2505)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82613797623
- Kyonggi-do
  - Seongnam, Kyonggi-do, South Korea, 13620
    - Recruiting
    - Seoul National University Bundang Hospital ( Site 2504)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82317877039
- Taejon-Kwangyokshi
  - Taejŏn, Taejon-Kwangyokshi, South Korea, 35015
    - Recruiting
    - Chungnam National University Hospital ( Site 2506)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +82422808369
Spain
- - Barcelona, Spain, 08036
    - Recruiting
    - Hospital Clinic de Barcelona ( Site 1810)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34932275402
  - Barcelona, Spain, 08035
    - Recruiting
    - Hospital Universitari Vall d'Hebron ( Site 1804)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34934894350
  - Córdoba, Spain, 14004
    - Recruiting
    - Hospital Universitario Reina Sofia ( Site 1809)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34957011464
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Clinico San Carlos ( Site 1802)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34 91 330 35 46
  - Madrid, Spain, 28040
    - Recruiting
    - Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34915504800-2869
  - Madrid, Spain, 28041
    - Recruiting
    - Hospital Universitario 12 de Octubre ( Site 1800)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34913908307
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - Recruiting
    - Institut Català d'Oncologia - L'Hospitalet ( Site 1805)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34932607744
- Cantabria
  - Santander, Cantabria, Spain, 39008
    - Recruiting
    - Hospital Universitario Marqués de Valdecilla ( Site 1807)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34 942 20 25 25
- Gerona
  - Girona, Gerona, Spain, 17007
    - Recruiting
    - Institut Català d'Oncologia (ICO) - Girona ( Site 1806)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34972225832
- Madrid, Comunidad de
  - Madrid, Madrid, Comunidad de, Spain, 28034
    - Recruiting
    - Hospital Universitario Ramón y Cajal ( Site 1801)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34 913368263
- Valenciana, Comunitat
  - Valencia, Valenciana, Comunitat, Spain, 46009
    - Recruiting
    - Fundación Instituto Valenciano de Oncología ( Site 1808)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +34 961114605
Taiwan
- - Taichung, Taiwan, 40447
    - Recruiting
    - China Medical University Hospital ( Site 2603)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886422052121
  - Taichung, Taiwan, 40705
    - Recruiting
    - Taichung Veterans General Hospital ( Site 2602)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886423592525x5121
  - Taipei, Taiwan, 11217
    - Recruiting
    - Taipei Veterans General Hospital ( Site 2600)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +886218712121x86334
  - Taoyuan, Taiwan, 333
    - Recruiting
    - Chang Gung Memorial Hospital - Linkou Branch ( Site 2604)
    - Contact:
      
      Study Coordinator
      
      Phone Number: +88633281200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has a histologically confirmed diagnosis of unresectable, advanced renal cell cancer (RCC) with clear cell component (with or without sarcomatoid features) i.e., Stage IV renal cell cancer per American Joint Committee on Cancer (AJCC) (8th Edition)
Has measurable disease per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1)
Has disease recurrence during adjuvant anti-programmed cell death 1/programmed cell death ligand 1 (PD-1/L1) therapy or recurrence ≤24 months following the last dose of adjuvant anti-PD-1/L1 therapy
Has received no other prior systemic therapy for their RCC except for their adjuvant anti-PD-1/L1 therapy

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, new-onset angina, pulmonary embolism, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability
Had deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
Has had major surgery within 8 weeks before randomization or has not adequately recovered from major surgery or has ongoing surgical complications
Has current pneumonitis/interstitial lung disease
Has symptomatic pleural effusion (for example cough, dyspnea, pleuritic chest pain), ascites, or pericardial fluid requiring drainage within 4 weeks prior to randomization
Has a gastrointestinal disorder including those associated with a high risk of perforation or fistula formation
Has a serious active nonhealing wound/ulcer/bone fracture
Has a requirement for hemodialysis or peritoneal dialysis
Has history of human immunodeficiency virus infection
Has hepatitis B or hepatitis C virus
Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Belzutifan plus Zanzalintinib Participants will receive belzutifan orally once daily (QD) PLUS zanzalintinib orally QD until one of the reasons for discontinuation of study intervention are met.	Drug: Belzutifan Administered orally QD Other Names: MK-6482 PT2977 WELIREG™ Drug: Zanzalintinib Administered orally QD Other Names: XL092
Active Comparator: Cabozantinib Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.	Drug: Cabozantinib Administered orally QD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival (PFS) Time Frame: Up to approximately 73 months	PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. PD will be assessed by Response Criteria in Solid Tumors Version 1.1 (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 (BICR) will be presented.	Up to approximately 73 months
Overall Survival (OS) Time Frame: Up to approximately 73 months	OS is defined as the time from randomization to death due to any cause.	Up to approximately 73 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR) Time Frame: Up to approximately 73 months	ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.	Up to approximately 73 months
Duration of Response (DOR) Time Frame: Up to approximately 73 months	For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 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 at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by Blinded Independent Central Review (BICR) will be presented.	Up to approximately 73 months
Number of Participants Who Experience One or More Adverse Events (AEs) Time Frame: Up to approximately 73 months	An 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. The number of participants who experienced an AE will be reported.	Up to approximately 73 months
Number of Participants Who Discontinue Study Treatment due to an AE Time Frame: Up to approximately 73 months	An 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. The number of participants who discontinue the study treatment due to an AE will be reported.	Up to approximately 73 months
Change From Baseline in European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire 30 (EORTC QLQ-C30) Global Health/Health-Related Quality of Life (HRQoL) Items 29 and 30 Combined Score Time Frame: Up to approximately 25 months	The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to the questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and Quality of Life (QoL; "How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent), then summed. Summed raw scores are standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better overall outcome.	Up to approximately 25 months
Change From Baseline in EORTC QLC-C30 Physical Functioning Items 1-5 Score Time Frame: Up to approximately 25 months	The EORTC QLQ-C30 is a cancer specific health-related quality-of life (QoL) questionnaire. Participant responses to 5 questions about their physical functioning (Items 1-5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome.	Up to approximately 25 months
Change From Baseline in EORTC QLQ-C30 Role Functioning Items 6-7 Score Time Frame: Up to approximately 25 months	The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to 2 questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Summed raw scores are standardized by linear transformation so that scores ranged from 0 to 100, with a higher score indicating a better level of functioning.	Up to approximately 25 months
Change From Baseline in Functional Assessment of Cancer Therapy-Kidney Symptom Index-Disease-related Symptoms (FKSI-DRS) Items 1-9 Score Time Frame: Up to approximately 25 months	The FKSI-DRS index consists of a 9-item questionnaire that assesses the extent of participant symptoms from kidney cancer. Responses are scored on a 5-point scale (0=Not at all to 4=Very much) and summed to generate an index symptom score. These scores can range from 0 to 36, with a higher score indicating more favorable kidney cancer symptom status.	Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Global Health/HRQoL Score Time Frame: Up to approximately 25 months	Time to True Deterioration (TTD) is defined as the time from baseline to the first onset of a ≥10-point decrease with confirmation by the subsequent visit of a ≥10-point decrease in Items 29 and 30 scale scores. A longer TTD indicates a better outcome. TTD is reported based on the product-limit (Kaplan-Meier) method for censored data.	Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Physical Functioning Score Time Frame: Up to approximately 25 months	TTD is defined as the time from baseline to the first onset of a ≥10-point deterioration (decrease) from baseline in physical functioning score (EORTC QLQ-C30 Items 1-5). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10-point negative change (decrease) from baseline in physical functioning score will be presented. A longer TTD indicates a better outcome.	Up to approximately 25 months
Time From Baseline to First Deterioration in EORTC-QLC-C30 Role Functioning Score Time Frame: Up to approximately 25 months	TTD is defined as the time from baseline to the first onset of a ≥10-point negative change (decrease) from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) score. Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The TTD, as assessed based on a ≥10 point negative change (decrease) from baseline in role functioning score, will be presented. A longer TTD indicates a better outcome.	Up to approximately 25 months
Time From Baseline to First Deterioration in FKSI-DRS Score Time Frame: Up to approximately 25 months	TTD is defined as time from the first dose of study treatment to the date of deterioration of FKSI-DRS Score. Each item is scored on a 5-point scale (0=not at all to 4=very much). FKSI-DRS total score ranged from 0 (most severe symptoms) to 36 (no symptoms) with a higher score indicating a better outcome. Deterioration is defined as a 3-point decrease (i.e. lower score) in symptom score and the time to true deterioration is the time to first onset of 3 or more decreases from baseline with confirmation under right-censoring rule (the last observation). A longer TTD indicates a better outcome.	Up to approximately 25 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Exelixis

Investigators

Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2025

Primary Completion (Estimated)

February 27, 2032

Study Completion (Estimated)

February 27, 2032

Study Registration Dates

First Submitted

November 7, 2025

First Submitted That Met QC Criteria

November 7, 2025

First Posted (Actual)

November 12, 2025

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 8, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

6482-033
U1111-1311-6892 (Registry Identifier: UTN)
2024-517136-21 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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Clinical Trials on Belzutifan

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