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NCT07489495From ClinicalTrials.govRecruiting

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)

  • Carcinoma, Renal Cell

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
758
Started
9 April 2026
Main results due
27 November 2030
Study sites
92
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has a histologically confirmed diagnosis of unresectable, advanced renal cell carcinoma (RCC) with clear cell component (with or without sarcomatoid features) ie, Stage IV RCC per American Joint Committee on Cancer (8th Edition)
* Has measurable disease per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)
* Has received no more than 3 prior systemic regimens for RCC, including only 1 prior anti-Programmed Cell Death-1/Programmed Cell Death 1 Ligand 1 therapy

Exclusion Criteria:

For exclusion criteria: The main exclusion criteria include but are not limited to the following:

* Has any of the following: a pulse oximeter reading \<92% at rest, requires intermittent supplemental oxygen, or required chronic supplemental oxygen
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
* Has deep vein thrombosis within 3 months before randomization unless stable, asymptomatic, and treated with therapeutic anticoagulation for at least 4 weeks before randomization
* Has a left ventricular ejection fraction ≤50% or below the institutional (or local laboratory) normal range as determined by multigated acquisition or echocardiogram
* Has had major surgery within 8 weeks before randomization
* Has current pneumonitis/interstitial lung disease
* Has a history of human immunodeficiency virus infection
* Has Hepatitis B or Hepatitis C virus infection
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has a history of solid organ transplant
* Has not adequately recovered from major surgery or has ongoing surgical complications

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(92)

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

    Marietta, Georgia, United States

    Recruiting

  • Washington University School of Medicine ( Site 0114)

    St Louis, Missouri, United States

    Recruiting

  • Memorial Sloan Kettering Cancer Center ( Site 0126)

    New York, New York, United States

    Recruiting

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

    Germantown, Tennessee, United States

    Recruiting

  • Centro Oncologico Korben ( Site 0254)

    CABA, Buenos Aires, Argentina

    Recruiting

  • Hospital Italiano de Buenos Aires ( Site 0253)

    Ciudad de Buenos Aires, Buenos Aires, Argentina

    Recruiting

  • Instituto de Investigaciones Clinicas Mar del Plata ( Site 0250)

    Mar del Plata, Buenos Aires, Argentina

    Recruiting

  • Centro Privado de RMI Río Cuarto S.A. II ( Site 0255)

    Río Cuarto, Córdoba Province, Argentina

    Recruiting

  • Sanatorio Parque ( Site 0251)

    Rosario, Santa Fe Province, Argentina

    Recruiting

  • Instituto de Oncología de Rosario ( Site 0257)

    Rosario, Santa Fe Province, Argentina

    Recruiting

  • Instituto Alexander Fleming ( Site 0252)

    CABA, Argentina

    Recruiting

  • Centro Oncológico Riojano Integral ( Site 0256)

    La Rioja, Argentina

    Recruiting

  • COE (Centro Oncológico de Excelencia) ( Site 0259)

    San Juan, Argentina

    Recruiting

  • Macquarie University ( Site 2700)

    Macquarie University, New South Wales, Australia

    Suspended

  • Princess Alexandra Hospital ( Site 2703)

    Woolloongabba, Queensland, Australia

    Suspended

  • Peter MacCallum Cancer Centre ( Site 2702)

    Melbourne, Victoria, Australia

    Suspended

  • CEDOES ( Site 0303)

    Vitória, Espírito Santo, Brazil

    Recruiting

  • Instituto do Câncer e Transplante de Curitiba ( Site 0300)

    Curitiba, Paraná, Brazil

    Recruiting

  • Liga Norte Riograndense Contra o Câncer ( Site 0307)

    Natal, Rio Grande do Norte, Brazil

    Recruiting

  • Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306)

    Ribeirão Preto, São Paulo, Brazil

    Recruiting

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

    São José do Rio Preto, São Paulo, Brazil

    Recruiting

  • The Ottawa Hospital Cancer Centre ( Site 0003)

    Ottawa, Ontario, Canada

    Recruiting

  • IC La Serena Research ( Site 0405)

    La Serena, Coquimbo Region, Chile

    Recruiting

  • Clínica Puerto Montt ( Site 0404)

    Port Montt, Los Lagos Region, Chile

    Recruiting

  • Fundacion Arturo Lopez Perez ( Site 0401)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Bradfordhill ( Site 0400)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • ONCOCENTRO APYS ( Site 0403)

    Viña del Mar, Valparaiso, Chile

    Recruiting

  • Masarykuv onkologicky ustav ( Site 0903)

    Brno, Brno-mesto, Czechia

    Recruiting

  • Fakultni nemocnice Ostrava ( Site 0904)

    Ostrava, Ostrava Mesto, Czechia

    Recruiting

  • Fakultni nemocnice Hradec Kralove ( Site 0902)

    Hradec Králové, Czechia

    Recruiting

  • Fakultni nemocnice Olomouc ( Site 0901)

    Olomouc, Czechia

    Recruiting

  • Fakulti poliklinika ( Site 0906)

    Prague, Czechia

    Recruiting

  • Fakultni nemocnice v Motole ( Site 0900)

    Prague, Czechia

    Recruiting

  • Herlev Hospital ( Site 1002)

    Herlev, Capital Region, Denmark

    Recruiting

  • Aarhus Universitetshospital, Skejby ( Site 1001)

    Aarhus, Central Jutland, Denmark

    Recruiting

  • Centre Antoine Lacassagne ( Site 1209)

    Nice, Alpes-Maritimes, France

    Recruiting

  • Hopital Europeen Marseille ( Site 1216)

    Marseille, Bouches-du-Rhone, France

    Recruiting

  • LBM ONCOPOLE CLAUDIUS REGAUD ( Site 1215)

    Toulouse, Haute-Garonne, France

    Recruiting

  • CHU Angers ( Site 1204)

    Angers, Maine-et-Loire, France

    Recruiting

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

    Le Mans, Pays de la Loire Region, France

    Recruiting

  • CHU de Saint-Etienne ( Site 1202)

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

    Recruiting

  • Universitaetsklinikum Augsburg ( Site 1316)

    Augsburg, Bavaria, Germany

    Recruiting

  • klinikum rechts der isar der technischen universität münchen ( Site 1315)

    Munich, Bavaria, Germany

    Recruiting

  • Universitätsklinikum Jena ( Site 1313)

    Jena, Thuringia, Germany

    Recruiting

  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312)

    Berlin, Germany

    Recruiting

  • Alexandra General Hospital of Athens ( Site 1400)

    Athens, Attica, Greece

    Recruiting

  • ATTIKON GENERAL UNIVERSITY HOSPITAL ( Site 1401)

    Athens, Attica, Greece

    Recruiting

  • Metropolitan Hospital ( Site 1402)

    Athens, Attica, Greece

    Recruiting

  • Rambam Health Care Campus ( Site 1600)

    Haifa, Israel

    Recruiting

  • Meir Medical Center. ( Site 1603)

    Kfar Saba, Israel

    Recruiting

  • Rabin Medical Center ( Site 1602)

    Petah Tikva, Israel

    Recruiting

  • Sheba Medical Center ( Site 1601)

    Ramat Gan, Israel

    Recruiting

  • IRCCS - Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori" ( Site 1809)

    Meldola, Emilia-Romagna, Italy

    Recruiting

  • Istituto Clinico Humanitas ( Site 1808)

    Rozzano, Milano, Italy

    Recruiting

  • Istituto Oncologico Veneto IRCCS ( Site 1806)

    Catselfranco Veneto, Padova, Italy

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi ( Site 1807)

    Florence, Tuscany, Italy

    Recruiting

  • A.O.U.C. Policlinico di Bari ( Site 1802)

    Bari, Italy

    Recruiting

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803)

    Bologna, Italy

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 1800)

    Milan, Italy

    Recruiting

  • AO Santa Maria della Misericordia ( Site 1805)

    Perugia, Italy

    Recruiting

Showing 60 of 92 sites — filter to narrow it down. 89 of the 92 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07489495. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Clinical Study of Belzutifan (MK-6482) and Zanzalintinib in People With Renal Cell Carcinoma (RCC) (LITESPAR | Trialion