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A Clinical Study of Belzutifan and Zanzalintinib in People With Recurrent Kidney Cancer Following Adjuvant Therapy (MK-6482-033)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
Official title: 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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
904
Start Date
2025-11-26
Completion Date
2032-02-27
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
Administered orally QD
Zanzalintinib
Administered orally QD
Cabozantinib
Administered orally QD
Locations (91)
Hospital Italiano de Buenos Aires. ( Site 0203)
Caba, Buenos Aires, Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
Caba, Buenos Aires, Argentina
Instituto Alexander Fleming ( Site 0202)
CABA, Buenos Aires, Argentina
Centro de Educación Médica e Investigaciones clínicas "Dr. Norberto Quirno" (CEMIC) ( Site 0208)
Caba., Buenos Aires F.D., Argentina
Sanatorio Parque ( Site 0201)
Rosario, Santa Fe Province, Argentina
Instituto de Oncología de Rosario ( Site 0209)
Rosario, Santa Fe Province, Argentina
Hospital Privado Universitario de Córdoba ( Site 0207)
Córdoba, Argentina
Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)
Sydney, New South Wales, Australia
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)
Linz, Upper Austria, Austria
Medizinische Universitat Wien ( Site 0601)
Vienna, Austria
Cliniques Universitaires Saint-Luc ( Site 0703)
Brussels, Bruxelles-Capitale, Region de, Belgium
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701)
Genk, Limburg, Belgium
UZ Gent ( Site 0702)
Ghent, Oost-Vlaanderen, Belgium
UZ Leuven ( Site 0700)
Leuven, Vlaams-Brabant, Belgium
Masarykuv onkologicky ustav ( Site 0903)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 0904)
Ostrava, Ostrava Mesto, Czechia
Nemocnice České Budějovice ( Site 0905)
České Budějovice, Czechia
Fakultni nemocnice Hradec Kralove ( Site 0902)
Hradec Králové, Czechia
Fakultni nemocnice Olomouc ( Site 0901)
Olomouc, Czechia
Vseobecna fakultni nemocnice v Praze ( Site 0906)
Prague, Czechia
Fakultni nemocnice v Motole ( Site 0900)
Prague, Czechia
Herlev Hospital ( Site 1002)
Herlev, Capital Region, Denmark
Odense Universitetshospital ( Site 1000)
Odense, Region Syddanmark, Denmark
CHU de Bordeaux Hop St ANDRE ( Site 1115)
Bordeaux, Gironde, France
Hôpital Foch ( Site 1118)
Suresnes, Hauts-de-Seine, France
Centre de Cancérologie du Grand Montpellier ( Site 1112)
Montpellier, Herault, France
CHU GRENOBLE ALPES ( Site 1101)
La Tronche, Isere, France
Centre d'Oncologie de Gentilly ( Site 1117)
Nancy, Lorraine, France
Centre Hospitalier Universitaire d'Angers-Urology ( Site 1104)
Angers, Pays de la Loire Region, France
Centre Hospitalier de la Côte Basque ( Site 1113)
Bayonne, Pyrenees-Atlantiques, France
centre hospitalier lyon sud ( Site 1102)
Pierre-Bénite, Rhone, France
HENRI MONDOR HOSPITAL ( Site 1116)
Créteil, Val-de-Marne, France
CHD Vendee ( Site 1103)
La Roche-sur-Yon, Vendee, France
Klinikum Stuttgart - Katharinenhospital ( Site 1201)
Stuttgart, Baden-Wurttemberg, Germany
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1211)
Göttingen, Lower Saxony, Germany
Helios Kliniken Schwerin GmbH ( Site 1206)
Schwerin, Mecklenburg-Vorpommern, Germany
Universitaetsklinikum Muenster ( Site 1202)
Münster, North Rhine-Westphalia, Germany
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)
Dresden, Saxony, Germany
HELIOS Klinikum Erfurt ( Site 1208)
Erfurt, Thuringia, Germany
Universitätsklinikum Jena ( Site 1204)
Jena, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1203)
Berlin, Germany
Universitaetsklinikum Hamburg-Eppendorf ( Site 1214)
Hamburg, Germany
Alexandra General Hospital of Athens ( Site 1300)
Athens, Attica, Greece
Metropolitan Hospital ( Site 1302)
Athens, Attica, Greece
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 1301)
Chaïdári, Attica, Greece
Prince of Wales Hospital ( Site 2200)
Hong Kong, Hong Kong
Queen Mary Hospital ( Site 2201)
Hong Kong, Hong Kong
Cork University Hospital ( Site 1501)
Cork, Ireland
Istituto Nazionale Tumori Regina Elena ( Site 1611)
Rome, Lazio, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600)
Milan, Milano, Italy
Istituto Clinico Humanitas ( Site 1613)
Rozzano, Milano, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)
Rome, Roma, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 1608)
Florence, Tuscany, Italy
Casa di Cura Dott. Pederzoli - UO Oncologia ( Site 1610)
Peschiera del Garda, Veneto, Italy
Azienda USL 8 di Arezzo ( Site 1605)
Arezzo, Italy
Ospedale San Martino ( Site 1606)
Genova, Italy
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0503)
Guadalajara, Jalisco, Mexico
I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 0507)
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca ( Site 0502)
Oaxaca City, Oaxaca, Mexico
Higiea Oncologia ( Site 0504)
Mexico City, Mexico
Clinica Integral Internacional de Oncología ( Site 0506)
Puebla City, Mexico
AIDPORT Sp. z o.o. ( Site 1716)
Skórzewo, Greater Poland Voivodeship, Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1707)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Pratia MCM Krakow ( Site 1713)
Krakow, Lesser Poland Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1703)
Krakow, Lesser Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1702)
Siedlce, Masovian Voivodeship, Poland
MTZ Clinical Research Powered by Pratia ( Site 1705)
Warsaw, Masovian Voivodeship, Poland
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1710)
Przemyśl, Podkarpackie Voivodeship, Poland
National University Hospital ( Site 2400)
Singapore, Central Singapore, Singapore
National Cancer Centre Singapore ( Site 2401)
Singapore, Central Singapore, Singapore
Chonnam National University Hwasun Hospital ( Site 2505)
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Bundang Hospital ( Site 2504)
Seongnam, Kyonggi-do, South Korea
Chungnam National University Hospital ( Site 2506)
Taejŏn, Taejon-Kwangyokshi, South Korea
Severance Hospital, Yonsei University Health System ( Site 2503)
Seoul, South Korea
Asan Medical Center ( Site 2501)
Seoul, South Korea
Samsung Medical Center ( Site 2502)
Seoul, South Korea
Institut Català d'Oncologia - L'Hospitalet ( Site 1805)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla ( Site 1807)
Santander, Cantabria, Spain
Institut Català d'Oncologia (ICO) - Girona ( Site 1806)
Girona, Gerona, Spain
Hospital Universitario Ramón y Cajal ( Site 1801)
Madrid, Madrid, Comunidad de, Spain
Fundación Instituto Valenciano de Oncología ( Site 1808)
Valencia, Valenciana, Comunitat, Spain
Hospital Universitari Vall d'Hebron ( Site 1804)
Barcelona, Spain
Hospital Clinic de Barcelona ( Site 1810)
Barcelona, Spain
Hospital Universitario Reina Sofia ( Site 1809)
Córdoba, Spain
Hospital Clinico San Carlos ( Site 1802)
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)
Madrid, Spain
Hospital Universitario 12 de Octubre ( Site 1800)
Madrid, Spain
China Medical University Hospital ( Site 2603)
Taichung, Taiwan
Taichung Veterans General Hospital ( Site 2602)
Taichung, Taiwan
Taipei Veterans General Hospital ( Site 2600)
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou Branch ( Site 2604)
Taoyuan District, Taiwan