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
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 450 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 57 sites (Boston, Massachusetts and 56 other locations) |
| Status | Recruiting |
| Started | March 23, 2026 |
| Main results expected | April 22, 2034 |
| Study ends | April 22, 2034 |
| Registry record updated | October 21, 2026 |
| Trial ID | NCT07405164 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
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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
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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
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.