Clinical trial Recruiting at 50 sites Phase 3 Interventional Ages 18 and up

Extension program for people previously treated with belzutifan (MK-6482)

Official title: A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long-term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)

Run by Merck Sharp & Dohme LLC · NCT07405164 · Data updated 2026-11-12

This extension lets people with advanced solid tumors or VHL-related tumors who were already taking belzutifan in another study continue the drug so researchers can see how long they live and watch for long-term effects.

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment450 (estimated)
SponsorMerck Sharp & Dohme LLC
Industry-sponsored
Locations57 sites (Boston, Massachusetts and 56 other locations)
StatusRecruiting
StartedMarch 23, 2026
Main results expectedApril 22, 2034
Study endsApril 22, 2034
Registry record updatedOctober 21, 2026
Trial IDNCT07405164 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with advanced solid tumors or VHL-related neoplasms who are already receiving belzutifan in an eligible parent study and are clinically stable or have restarted treatment after an interruption.

Probably not a fit

Patients who were not enrolled in a belzutifan parent trial, who have ongoing serious adverse events, or who remain hospitalized or clinically unstable are unlikely to be eligible or to benefit from this extension.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label extension enrolls participants who received belzutifan in qualifying parent trials to continue active treatment and long-term follow-up. The program collects safety data, duration of drug exposure, and survival outcomes while monitoring adverse events over time. Enrollment is limited to patients who are clinically stable or have resumed treatment after a temporary interruption in their parent study. The trial is sponsored by Merck and conducted at selected sites in the United States and Israel.

Why it matters

Potential benefit: If successful, the extension could clarify how durable belzutifan's benefits are and provide safety information that helps guide longer-term use for patients with VHL-related tumors and advanced solid cancers.

How similar studies have gone: Prior belzutifan trials have shown clinical activity in VHL-associated tumors and advanced renal cell carcinoma, supporting this extension for long-term safety and survival follow-up.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Beth Israel Deaconess Medical Center ( Site 0107)
    Boston, Massachusetts, United States
    Recruiting
  • Dana-Farber Cancer Institute ( Site 0105)
    Boston, Massachusetts, United States
    Recruiting
  • Karmanos Cancer Center ( Site 0108)
    Detroit, Michigan, United States
    Recruiting
  • Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100)
    Philadelphia, Pennsylvania, United States
    Recruiting
  • UPMC Hillman Cancer Center ( Site 0101)
    Pittsburgh, Pennsylvania, United States
    Recruiting
  • SCRI Oncology Partners ( Site 7000)
    Nashville, Tennessee, United States
    Recruiting
Show 44 more locations
  • START San Antonio ( Site 0104)
    San Antonio, Texas, United States
    Recruiting
  • Fred Hutchinson Cancer Center ( Site 0106)
    Seattle, Washington, United States
    Recruiting
  • St George Hospital-Oncology Clinical Research Unit ( Site 2701)
    Kogarah, New South Wales, Australia
    Recruiting
  • Westmead Hospital ( Site 2703)
    Sydney, New South Wales, Australia
    Recruiting
  • Frankston Hospital-Oncology and Haematology ( Site 2705)
    Frankston, Victoria, Australia
    Recruiting
  • One Clinical Research ( Site 2704)
    Nedlands, Western Australia, Australia
    Recruiting
  • UZ Leuven ( Site 0900)
    Leuven, Vlaams-Brabant, Belgium
    Recruiting
  • James Lind Centro de Investigacion del Cancer ( Site 0304)
    Temuco, Araucania, Chile
    Recruiting
  • CIDO SpA ( Site 0305)
    Temuco, Araucania, Chile
    Recruiting
  • Fundación Arturo López Pérez ( Site 0300)
    Santiago, Region M. de Santiago, Chile
    Recruiting
  • Oncovida ( Site 0303)
    Santiago, Region M. de Santiago, Chile
    Recruiting
  • Bradfordhill ( Site 0301)
    Santiago, Region M. de Santiago, Chile
    Recruiting
  • ONCOCENTRO APYS ( Site 0302)
    Viña del Mar, Valparaiso, Chile
    Recruiting
  • Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000)
    Olomouc, Czechia
    Recruiting
  • Herlev and Gentofte Hospital ( Site 1200)
    Herlev, Capital Region, Denmark
    Recruiting
  • Tampereen yliopistollinen sairaala ( Site 1305)
    Tampere, Pirkanmaa, Finland
    Recruiting
  • Hôpitaux Universitaires de Strasbourg ( Site 1702)
    Strasbourg, Bas-Rhin, France
    Recruiting
  • Institut Claudius Regaud ( Site 1703)
    Toulouse, Haute-Garonne, France
    Recruiting
  • Gustave Roussy ( Site 1701)
    Villejuif, Val-de-Marne, France
    Recruiting
  • Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501)
    Budapest, Hungary
    Recruiting
  • Rambam Health Care Campus ( Site 1600)
    Haifa, Israel
    Recruiting
  • Hadassah Medical Center ( Site 1604)
    Jerusalem, Israel
    Recruiting
  • Rabin Medical Center ( Site 1602)
    Petah Tikva, Israel
    Recruiting
  • Sheba Medical center ( Site 1601)
    Ramat Gan, Israel
    Recruiting
  • Sourasky Medical Center ( Site 1603)
    Tel Aviv, Israel
    Recruiting
  • Toranomon Hospital ( Site 3100)
    Minato, Tokyo, Japan
    Recruiting
  • Kyushu University Hospital ( Site 3101)
    Fukuoka, Japan
    Recruiting
  • Tokushima University Hospital ( Site 3102)
    Tokushima, Japan
    Recruiting
  • Maastricht Universitair Medisch Centrum - MUMC ( Site 1900)
    Maastricht, Limburg, Netherlands
    Recruiting
  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 1901)
    Amsterdam, North Holland, Netherlands
    Recruiting
  • Isala, locatie Zwolle ( Site 1902)
    Zwolle, Overijssel, Netherlands
    Recruiting
  • Auckland City Hospital ( Site 3000)
    Auckland, New Zealand
    Recruiting
  • Centrum Onkologii im. Prof. Franciszka Lukaszczyka ( Site 2000)
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
    Recruiting
  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 2002)
    Warsaw, Masovian Voivodeship, Poland
    Recruiting
  • Samsung Medical Center ( Site 2902)
    Gangnam, Seoul, South Korea
    Recruiting
  • Severance Hospital, Yonsei University Health System ( Site 2901)
    Seodaemun-gu, Seoul, South Korea
    Recruiting
  • Asan Medical Center ( Site 2900)
    Seoul, South Korea
    Recruiting
  • Hospital Universitari Vall d'Hebron ( Site 2300)
    Barcelona, Spain
    Recruiting
  • Hospital Universitario 12 de Octubre ( Site 2301)
    Madrid, Spain
    Recruiting
  • ME І.І. Mechnykov Dnipro Regional Clinical Hospital ( Site 2601)
    Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
    Recruiting
  • The Beatson West of Scotland Cancer Centre ( Site 2505)
    Glasgow, Glasgow City, United Kingdom
    Recruiting
  • St Bartholomew's Hospital ( Site 2500)
    London, London, City of, United Kingdom
    Recruiting
  • ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 2502)
    London, London, City of, United Kingdom
    Recruiting
  • The Christie NHS Foundation Trust ( Site 2501)
    Manchester, United Kingdom
    Recruiting

+7 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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  • Real-world belzutifan outcomes and pharmacogenetics in von Hippel-Lindau syndrome

    This study will test belzutifan in people aged 14 and older with VHL syndrome to see how well it controls VHL-associated tumors, what side effects occur, and how genetic factors affect response.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.