RecruitingPhase 3NCT07489495

A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPARK-034/LS-034/MK-6482-034)

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)


Sponsor

Merck Sharp & Dohme LLC

Enrollment

758 participants

Start Date

Apr 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Belzutifan, a drug called Placebo, and others for people with carcinoma, renal cell. The study is currently recruiting participants at 52 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBelzutifan

Tablet for oral administration.

DRUGZanzalintinib

Tablet for oral administration.

DRUGPlacebo

Zanzalintinib-matching placebo tablet for oral administration.


Locations(66)

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102)

Marietta, Georgia, United States

The West Clinic, P.C. ( Site 0115)

Germantown, Tennessee, United States

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

CEDOES ( Site 0303)

Vitória, Espírito Santo, Brazil

Instituto do Câncer e Transplante de Curitiba ( Site 0300)

Curitiba, Paraná, Brazil

Liga Norte Riograndense Contra o Câncer ( Site 0307)

Natal, Rio Grande do Norte, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302)

São José do Rio Preto, São Paulo, 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

Centre Antoine Lacassagne ( Site 1209)

Nice, Alpes-Maritimes, France

Hopital Europeen Marseille ( Site 1216)

Marseille, Bouches-du-Rhone, France

LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)

Toulouse, Haute-Garonne, France

CHU Angers ( Site 1204)

Angers, Maine-et-Loire, France

Clinique Victor Hugo Le Mans-Oncology-Radiotherapy ( Site 1203)

Le Mans, Pays de la Loire Region, France

CHU de Saint-Etienne ( Site 1202)

Saint Priest En Jarez, Pays de la Loire Region, France

Universitätsklinikum Jena ( Site 1313)

Jena, Thuringia, Germany

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

AO Santa Maria della Misericordia ( Site 1805)

Perugia, 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

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2106)

Gliwice, Silesian 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)

Adana Medical Park Seyhan Hastanesi ( Site 2505)

Adana, Turkey (Türkiye)

Ankara University Health Practice and Research Hospitals ( Site 2506)

Ankara, Turkey (Türkiye)

Trakya University Medical Faculty Hospital ( Site 2502)

Edirne, Turkey (Türkiye)

Koc Universitesi Hastanesi ( Site 2501)

Istanbul, Turkey (Türkiye)

The Christie Hospital NHS Foundation Trust ( Site 2601)

Withington, Manchester, United Kingdom

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NCT07489495


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