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A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)
Sponsor: Merck Sharp & Dohme LLC
Summary
Researchers are looking for new ways to treat advanced renal cell carcinoma (RCC). A standard (usual) treatment for certain people with RCC is belzutifan (a study medicine), which is a targeted therapy. Targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. Researchers want to learn if adding another targeted therapy called zanzalintinib (another study medicine) can treat more people with advanced RCC than belzutifan alone. The goal of this study is to learn if people who receive belzutifan and zanzalintinib live longer overall and without the cancer getting worse compared to people who receive belzutifan and placebo.
Official title: A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants With Advanced RCC Who Have Progressed on or After Both PD-1/L1 and VEGF-TKI Therapies in Sequence or in Combination (LITESPARK-034)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
758
Start Date
2026-04-09
Completion Date
2030-11-27
Last Updated
2026-07-10
Healthy Volunteers
No
Conditions
Interventions
Belzutifan
Tablet for oral administration.
Zanzalintinib
Tablet for oral administration.
Placebo
Zanzalintinib-matching placebo tablet for oral administration.
Locations (52)
Centro Oncologico Korben ( Site 0254)
CABA, Buenos Aires, Argentina
Hospital Italiano de Buenos Aires ( Site 0253)
Ciudad de Buenos Aires, Buenos Aires, Argentina
Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)
Mar del Plata, Buenos Aires, Argentina
Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)
Río Cuarto, Córdoba Province, Argentina
Sanatorio Parque ( Site 0251)
Rosario, Santa Fe Province, Argentina
Instituto de Oncología de Rosario ( Site 0257)
Rosario, Santa Fe Province, Argentina
Instituto Alexander Fleming ( Site 0252)
CABA, Argentina
Centro Oncológico Riojano Integral ( Site 0256)
La Rioja, Argentina
COE (Centro Oncológico de Excelencia) ( Site 0259)
San Juan, Argentina
Macquarie University ( Site 2700)
Macquarie University, New South Wales, Australia
Instituto do Câncer e Transplante de Curitiba ( Site 0300)
Curitiba, Paraná, Brazil
Masarykuv onkologicky ustav ( Site 0903)
Brno, Brno-mesto, Czechia
Fakultni nemocnice Ostrava ( Site 0904)
Ostrava, Ostrava Mesto, Czechia
Fakultni nemocnice Hradec Kralove ( Site 0902)
Hradec Králové, Czechia
Fakultni nemocnice v Motole ( Site 0900)
Prague, Czechia
Herlev Hospital ( Site 1002)
Herlev, Capital Region, Denmark
Aarhus Universitetshospital, Skejby ( Site 1001)
Aarhus, Central Jutland, Denmark
Hopital Europeen Marseille ( Site 1216)
Marseille, Bouches-du-Rhone, France
Oncopole Claudius Regaud ( Site 1215)
Toulouse, Haute-Garonne, France
CHU Angers ( Site 1204)
Angers, Maine-et-Loire, France
Alexandra General Hospital of Athens ( Site 1400)
Athens, Attica, Greece
ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)
Athens, Attica, Greece
Metropolitan Hospital ( Site 1402)
Athens, Attica, Greece
Rambam Health Care Campus ( Site 1600)
Haifa, Israel
Meir Medical Center. ( Site 1603)
Kfar Saba, Israel
Rabin Medical Center ( Site 1602)
Petah Tikva, Israel
Sheba Medical Center ( Site 1601)
Ramat Gan, Israel
IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809)
Meldola, Emilia-Romagna, Italy
Azienda Ospedaliera Universitaria Careggi ( Site 1807)
Florence, Tuscany, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)
Milan, Italy
Istituto Nazionale Tumori Regina Elena ( Site 1804)
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1801)
Roma, Italy
Maastricht UMC+ ( Site 1901)
Maastricht, Limburg, Netherlands
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1900)
Amsterdam, North Holland, Netherlands
Haga Ziekenhuis locatie Leyweg ( Site 1906)
The Hague, South Holland, Netherlands
AIDPORT Sp. z o.o. ( Site 2118)
Skórzewo, Greater Poland Voivodeship, Poland
Pratia MCM Krakow ( Site 2115)
Krakow, Lesser Poland Voivodeship, Poland
Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2102)
Siedlce, Masovian Voivodeship, Poland
MTZ Clinical Research Powered by Pratia ( Site 2107)
Warsaw, Masovian Voivodeship, Poland
Severance Hospital, Yonsei University Health System ( Site 2903)
Seoul, South Korea
Asan Medical Center ( Site 2901)
Seoul, South Korea
Samsung Medical Center ( Site 2902)
Seoul, South Korea
Hospital Universitario Virgen del Rocio ( Site 2306)
Seville, Andalusia, Spain
Institut Català d'Oncologia - L'Hospitalet ( Site 2305)
L'Hospitalet de Llobregat, Barcelona, Spain
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 2301)
Madrid, Madrid, Comunidad de, Spain
Hospital Universitari Vall d'Hebron ( Site 2303)
Barcelona, Spain
Hospital Insular de Gran Canaria ( Site 2308)
Las Palmas, Spain
Hospital Universitario 12 de Octubre ( Site 2300)
Madrid, Spain
Fundación Instituto Valenciano de Oncología ( Site 2307)
Valencia, Spain
Hacettepe Universite Hastaneleri ( Site 2500)
Sıhhiye, Ankara, Turkey (Türkiye)
Trakya University Medical Faculty Hospital ( Site 2502)
Edirne, Turkey (Türkiye)
Koc Universitesi Hastanesi ( Site 2501)
Istanbul, Turkey (Türkiye)