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)
Status: Recruiting
Location: See all (93) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
⁃ 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
Locations
Other Locations
Argentina
Asociación de Beneficencia Hospital Sirio Libanés ( Site 0205)
RECRUITING
Caba
Hospital Italiano de Buenos Aires. ( Site 0203)
RECRUITING
Caba
Instituto Alexander Fleming ( Site 0202)
RECRUITING
Caba
Centro de Educación Médica e Investigaciones clínicas Dr. Norberto Quirno (CEMIC) ( Site 0208)
RECRUITING
Caba.
Hospital Privado Universitario de Córdoba ( Site 0207)
RECRUITING
Córdoba
Instituto de Oncología de Rosario ( Site 0209)
RECRUITING
Rosario
Sanatorio Parque ( Site 0201)
RECRUITING
Rosario
Australia
Macquarie University-MQ Health Clinical Trials Unit ( Site 2100)
RECRUITING
Sydney
Austria
Ordensklinikum Linz GmbH Elisabethinen-Urologie ( Site 0600)
RECRUITING
Linz
Medizinische Universitat Wien ( Site 0601)
RECRUITING
Vienna
Belgium
Cliniques Universitaires Saint-Luc ( Site 0703)
RECRUITING
Brussels
Ziekenhuis Oost-Limburg, Campus St.-Jan ( Site 0701)
RECRUITING
Genk
UZ Gent ( Site 0702)
RECRUITING
Ghent
UZ Leuven ( Site 0700)
RECRUITING
Leuven
Brazil
IPC - MT Instituto de Pesquisas Clínicas do Mato Grosso ( Site 0305)
RECRUITING
Cuiabá
Liga Norte Riograndense Contra o Câncer ( Site 0307)
RECRUITING
Natal
Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)
RECRUITING
São José Do Rio Preto
Hospital Alemao Oswaldo Cruz ( Site 0311)
RECRUITING
São Paulo
Denmark
Herlev Hospital ( Site 1002)
RECRUITING
Herlev
Odense Universitetshospital ( Site 1000)
RECRUITING
Odense
France
Centre Hospitalier Universitaire d'Angers-Urology ( Site 1104)
RECRUITING
Angers
Centre Hospitalier de la Côte Basque ( Site 1113)
RECRUITING
Bayonne
CHU de Bordeaux Hop St ANDRE ( Site 1115)
RECRUITING
Bordeaux
HENRI MONDOR HOSPITAL ( Site 1116)
RECRUITING
Créteil
CHD Vendee ( Site 1103)
RECRUITING
La Roche-sur-yon
CHU GRENOBLE ALPES ( Site 1101)
RECRUITING
La Tronche
Centre de Cancérologie du Grand Montpellier ( Site 1112)
RECRUITING
Montpellier
Centre d'Oncologie de Gentilly ( Site 1117)
RECRUITING
Nancy
centre hospitalier lyon sud ( Site 1102)
RECRUITING
Pierre-bénite
Hôpital Foch ( Site 1118)
RECRUITING
Suresnes
Germany
Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1203)
RECRUITING
Berlin
Universitaetsklinikum Carl Gustav Carus Dresden ( Site 1213)
RECRUITING
Dresden
HELIOS Klinikum Erfurt ( Site 1208)
RECRUITING
Erfurt
Universitätsmedizin Göttingen - Georg-August-Universität ( Site 1211)
RECRUITING
Göttingen
Universitaetsklinikum Hamburg-Eppendorf ( Site 1214)
RECRUITING
Hamburg
Marienhospital Herne ( Site 1215)
RECRUITING
Herne
Universitätsklinikum Jena ( Site 1204)
RECRUITING
Jena
Universitaetsklinikum Muenster ( Site 1202)
RECRUITING
Münster
Helios Kliniken Schwerin GmbH ( Site 1206)
RECRUITING
Schwerin
Klinikum Stuttgart - Katharinenhospital ( Site 1201)
RECRUITING
Stuttgart
UniversitaetsklInikum Tuebingen ( Site 1207)
RECRUITING
Tübingen
Greece
Alexandra General Hospital of Athens ( Site 1300)
RECRUITING
Athens
Metropolitan Hospital ( Site 1302)
RECRUITING
Athens
University General Hospital ''Attikon'' - General Hospital of West Attica H AGIA VARVARA ( Site 1301)
RECRUITING
Chaïdári
Hong Kong Special Administrative Region
Prince of Wales Hospital ( Site 2200)
RECRUITING
Hong Kong
Queen Mary Hospital ( Site 2201)
RECRUITING
Hong Kong
Ireland
Cork University Hospital ( Site 1501)
RECRUITING
Cork
Tallaght University Hospital ( Site 1500)
RECRUITING
Dublin
Italy
Azienda USL 8 di Arezzo ( Site 1605)
RECRUITING
Arezzo
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1604)
RECRUITING
Bologna
Azienda Ospedaliera Universitaria Careggi ( Site 1608)
RECRUITING
Florence
Ospedale San Martino ( Site 1606)
RECRUITING
Genova
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1600)
RECRUITING
Milan
Azienda Ospedaliera S. Luigi Gonzaga ( Site 1607)
RECRUITING
Orbassano
Casa di Cura Dott. Pederzoli - UO Oncologia ( Site 1610)
RECRUITING
Peschiera Del Garda
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1601)
RECRUITING
Rome
Istituto Nazionale Tumori Regina Elena ( Site 1611)
RECRUITING
Rome
Istituto Clinico Humanitas ( Site 1613)
RECRUITING
Rozzano
Mexico
CIO - Centro de Inmuno-Oncología de Occidente ( Site 0503)
RECRUITING
Guadalajara
Higiea Oncologia ( Site 0504)
RECRUITING
Mexico City
I CAN ONCOLOGY CENTER S.A. DE C.V. ( Site 0507)
RECRUITING
Monterrey
Centro de Investigacion Clinica de Oaxaca ( Site 0502)
RECRUITING
Oaxaca City
Clinica Integral Internacional de Oncología ( Site 0506)
RECRUITING
Puebla City
Poland
Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 1707)
RECRUITING
Bydgoszcz
Pratia MCM Krakow ( Site 1713)
RECRUITING
Krakow
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1703)
RECRUITING
Krakow
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1710)
RECRUITING
Przemyśl
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 1702)
RECRUITING
Siedlce
AIDPORT Sp. z o.o. ( Site 1716)
RECRUITING
Skórzewo
MTZ Clinical Research Powered by Pratia ( Site 1705)
RECRUITING
Warsaw
Republic of Korea
Chonnam National University Hwasun Hospital ( Site 2505)
RECRUITING
Hwasun-gun
Seoul National University Bundang Hospital ( Site 2504)
RECRUITING
Seongnam
Asan Medical Center ( Site 2501)
RECRUITING
Seoul
Samsung Medical Center ( Site 2502)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 2503)
RECRUITING
Seoul
Chungnam National University Hospital ( Site 2506)
RECRUITING
Taejŏn
Singapore
National Cancer Centre Singapore ( Site 2401)
RECRUITING
Singapore
National University Hospital ( Site 2400)
RECRUITING
Singapore
Spain
Hospital Clinic de Barcelona ( Site 1810)
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron ( Site 1804)
RECRUITING
Barcelona
Hospital Universitario Reina Sofia ( Site 1809)
RECRUITING
Córdoba
Institut Català d'Oncologia (ICO) - Girona ( Site 1806)
RECRUITING
Girona
Institut Català d'Oncologia - L'Hospitalet ( Site 1805)
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos ( Site 1802)
RECRUITING
Madrid
Hospital Universitario 12 de Octubre ( Site 1800)
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz ( Site 1803)
RECRUITING
Madrid
Hospital Universitario Ramón y Cajal ( Site 1801)
RECRUITING
Madrid
Hospital Universitario Marqués de Valdecilla ( Site 1807)
RECRUITING
Santander
Fundación Instituto Valenciano de Oncología ( Site 1808)
RECRUITING
Valencia
Taiwan
China Medical University Hospital ( Site 2603)
RECRUITING
Taichung
Taichung Veterans General Hospital ( Site 2602)
RECRUITING
Taichung
Taipei Veterans General Hospital ( Site 2600)
RECRUITING
Taipei
Chang Gung Memorial Hospital - Linkou Branch ( Site 2604)
RECRUITING
Taoyuan District
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2032-02-27
Participants
Target number of participants: 904
Treatments
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.
Active_comparator: Cabozantinib
Participants will receive cabozantinib orally QD until one of the reasons for discontinuation of study intervention are met.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC
Collaborators: Exelixis