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RECRUITING
NCT07489495
PHASE3

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Belzutifan

Tablet for oral administration.

DRUG

Zanzalintinib

Tablet for oral administration.

DRUG

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)