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RECRUITING Phase 3 ClinicalTrials.gov

Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)

Sponsor: Merck Sharp & Dohme LLC • ClinicalTrials.gov ID: NCT07405164

Registry updated: 2026-10-21
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Description

Researchers are looking for new ways to treat advanced solid tumors and von Hippel-Lindau (VHL)-related tumors: * Advanced means the cancer has spread to other parts of the body (metastatic) or cannot be removed with surgery * Solid tumors are cancers mostly in body organs and tissues, not in the blood or other body liquids * VHL-related tumors are tumors caused by VHL disease. VHL disease is passed down from parents to children and people with VHL disease have a higher chance of getting certain types of cancer Researchers want to learn about the long-term effects of a trial medicine called belzutifan. Belzutifan, also called MK-6482, is designed to block a protein that helps tumors grow and survive. This is an extension trial, which means only people who were in certain other belzutifan trials (called parent trials) may be able to join. The goal of this trial is to learn how long people live after they start taking belzutifan.

Interventions

  • Belzutifan (Drug)
    Belzutifan is administered orally at 120 mg once daily (qd) OR 200 mg qd until progressive disease (PD), unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Nivolumab (Drug)
    Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Lenvatinib (Drug)
    Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
  • Cabozantinib (Drug)
    Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.

Eligibility criteria

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study. Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable. * Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll.

Conditions

Von Hippel-Lindau Disease Malignant Neoplasms

Locations

  • Beth Israel Deaconess Medical Center ( Site 0107) — Boston, Massachusetts, United States
  • Dana-Farber Cancer Institute ( Site 0105) — Boston, Massachusetts, United States
  • Karmanos Cancer Center ( Site 0108) — Detroit, Michigan, United States
  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100) — Philadelphia, Pennsylvania, United States
  • UPMC Hillman Cancer Center ( Site 0101) — Pittsburgh, Pennsylvania, United States
  • SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States
  • START San Antonio ( Site 0104) — San Antonio, Texas, United States
  • Fred Hutchinson Cancer Center ( Site 0106) — Seattle, Washington, United States
  • St George Hospital-Oncology Clinical Research Unit ( Site 2701) — Kogarah, New South Wales, Australia
  • Westmead Hospital ( Site 2703) — Sydney, New South Wales, Australia
  • Frankston Hospital-Oncology and Haematology ( Site 2705) — Frankston, Victoria, Australia
  • One Clinical Research ( Site 2704) — Nedlands, Western Australia, Australia
  • UZ Leuven ( Site 0900) — Leuven, Vlaams-Brabant, Belgium
  • BP - A Beneficencia Portuguesa de São Paulo ( Site 0200) — São Paulo, São Paulo, Brazil
  • Jewish General Hospital ( Site 0001) — Montreal, Quebec, Canada
  • James Lind Centro de Investigacion del Cancer ( Site 0304) — Temuco, Araucania, Chile
  • CIDO SpA ( Site 0305) — Temuco, Araucania, Chile
  • Fundación Arturo López Pérez ( Site 0300) — Santiago, Region M. de Santiago, Chile
  • Oncovida ( Site 0303) — Santiago, Region M. de Santiago, Chile
  • Bradfordhill ( Site 0301) — Santiago, Region M. de Santiago, Chile
  • ONCOCENTRO APYS ( Site 0302) — Viña del Mar, Valparaiso, Chile
  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) — Olomouc, Czechia
  • Herlev and Gentofte Hospital ( Site 1200) — Herlev, Capital Region, Denmark
  • Tampereen yliopistollinen sairaala ( Site 1305) — Tampere, Pirkanmaa, Finland
  • Hôpitaux Universitaires de Strasbourg ( Site 1702) — Strasbourg, Bas-Rhin, France
  • Institut Claudius Regaud ( Site 1703) — Toulouse, Haute-Garonne, France
  • Gustave Roussy ( Site 1701) — Villejuif, Val-de-Marne, France
  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501) — Budapest, Hungary
  • Rambam Health Care Campus ( Site 1600) — Haifa, Israel
  • Hadassah Medical Center ( Site 1604) — Jerusalem, Israel
  • Rabin Medical Center ( Site 1602) — Petah Tikva, Israel
  • Sheba Medical center ( Site 1601) — Ramat Gan, Israel
  • Sourasky Medical Center ( Site 1603) — Tel Aviv, Israel
  • Toranomon Hospital ( Site 3100) — Minato, Tokyo, Japan
  • Kyushu University Hospital ( Site 3101) — Fukuoka, Japan
  • Tokushima University Hospital ( Site 3102) — Tokushima, Japan
  • Maastricht Universitair Medisch Centrum - MUMC ( Site 1900) — Maastricht, Limburg, Netherlands
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1901) — Amsterdam, North Holland, Netherlands
  • Isala, locatie Zwolle ( Site 1902) — Zwolle, Overijssel, Netherlands
  • Auckland City Hospital ( Site 3000) — Auckland, New Zealand
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2000) — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2002) — Warsaw, Masovian Voivodeship, Poland
  • N.N. Blokhin NMRCO ( Site 2101) — Moscow, Moscow, Russia
  • Russian Scientific Center of Radiology and Surgical Technologies ( Site 2100) — Saint Petersburg, Sankt-Peterburg, Russia
  • Samsung Medical Center ( Site 2902) — Gangnam, Seoul, South Korea
  • Severance Hospital, Yonsei University Health System ( Site 2901) — Seodaemun-gu, Seoul, South Korea
  • Asan Medical Center ( Site 2900) — Seoul, South Korea
  • Hospital Universitari Vall d'Hebron ( Site 2300) — Barcelona, Spain
  • Hospital Universitario 12 de Octubre ( Site 2301) — Madrid, Spain
  • Taipei Veterans General Hospital ( Site 2800) — Taipei, Taiwan
  • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601) — Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
  • CNCE Precarpathian Clinical Oncologic Center ( Site 2600) — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
  • The Beatson West of Scotland Cancer Centre ( Site 2505) — Glasgow, Glasgow City, United Kingdom
  • St Bartholomew's Hospital ( Site 2500) — London, London, City of, United Kingdom
  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502) — London, London, City of, United Kingdom
  • Imperial College Healthcare NHS Trust, Charing Cross Hospital ( Site 2504) — London, London, City of, United Kingdom
  • The Christie NHS Foundation Trust ( Site 2501) — Manchester, United Kingdom
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Official Source

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

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