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RECRUITING Phase 3 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT07489495

Registry updated: 2026-10-15
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Description

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.

Interventions

  • Belzutifan (Drug)
    Tablet for oral administration.
  • Zanzalintinib (Drug)
    Tablet for oral administration.
  • Placebo (Drug)
    Zanzalintinib-matching placebo tablet for oral administration.

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

Conditions

Carcinoma, Renal Cell

Locations

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0102) — Marietta, Georgia, United States
  • Norton Women's and Children's Hospital-Norton Cancer Institute - St. Matthews ( Site 0104) — Louisville, Kentucky, United States
  • Dana Farber Cancer Institute ( Site 0135) — Boston, Massachusetts, United States
  • Washington University School of Medicine ( Site 0114) — St Louis, Missouri, United States
  • Atlantic Health System Morristown Medical Center ( Site 0109) — Morristown, New Jersey, United States
  • Memorial Sloan Kettering Cancer Center ( Site 0126) — New York, New York, 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
  • Princess Alexandra Hospital ( Site 2703) — Woolloongabba, Queensland, Australia
  • Peter MacCallum Cancer Centre ( Site 2702) — Melbourne, Victoria, Australia
  • Fiona Stanley Hospital ( Site 2704) — Murdoch, Western Australia, 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
  • Hope - Humanizacao Em Oncologia, Pesquisa E Ensino ( Site 0306) — Ribeirão Preto, São Paulo, Brazil
  • Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0302) — São José do Rio Preto, São Paulo, Brazil
  • The Ottawa Hospital Cancer Centre ( Site 0003) — Ottawa, Ontario, Canada
  • IC La Serena Research ( Site 0405) — La Serena, Coquimbo Region, Chile
  • Clínica Puerto Montt ( Site 0404) — Port Montt, Los Lagos Region, Chile
  • Fundacion Arturo Lopez Perez ( Site 0401) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 0400) — Santiago, Region M. de Santiago, Chile
  • ONCOCENTRO APYS ( Site 0403) — Viña del Mar, Valparaiso, Chile
  • 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 Olomouc ( Site 0901) — Olomouc, Czechia
  • Fakulti poliklinika ( Site 0906) — Prague, 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
  • Gustave Roussy ( Site 1214) — Villejuif, Val-de-Marne, France
  • Universitaetsklinikum Augsburg ( Site 1316) — Augsburg, Bavaria, Germany
  • klinikum rechts der isar der technischen universität münchen ( Site 1315) — Munich, Bavaria, Germany
  • Universitätsklinikum Jena ( Site 1313) — Jena, Thuringia, Germany
  • Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 1312) — Berlin, 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
  • Istituto Clinico Humanitas ( Site 1808) — Rozzano, Milano, Italy
  • Istituto Oncologico Veneto IRCCS ( Site 1806) — Catselfranco Veneto, Padova, Italy
  • Azienda Ospedaliera Universitaria Careggi ( Site 1807) — Florence, Tuscany, Italy
  • Azienda Ospedaliera Policlinico di Bari ( Site 1802) — Bari, Italy
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola ( Site 1803) — Bologna, 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
  • Franciscus Gasthuis & Vlietland, Locatie Vlietland ( Site 1903) — Schiedam, South 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 im. Marii Sklodowskiej-Curie - P-Klinika Nowotworów Układu Moczowego ( Site 2100) — 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)
  • Ege Universitesi Hastanesi ( Site 2503) — Izmir, Turkey (Türkiye)
  • Addenbrookes Hospital ( Site 2605) — Cambridge, Cambridgeshire, United Kingdom
  • Western General Hospital ( Site 2608) — Edinburgh, Edinburgh, City of, United Kingdom
  • The Beatson West of Scotland Cancer Centre ( Site 2602) — Glasgow, Glasgow City, United Kingdom
  • Leicester Royal Infirmary ( Site 2604) — Leicester, Leicestershire, United Kingdom
  • The Christie Hospital NHS Foundation Trust ( Site 2601) — Withington, Manchester, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust ( Site 2610) — Birmingham, United Kingdom
  • Velindre Cancer Centre ( Site 2612) — Cardiff, United Kingdom
  • University Hospital of Southampton ( Site 2606) — Southampton, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record