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Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Sponsor: Merck Sharp & Dohme LLC
Summary
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-03-23
Completion Date
2034-01-14
Last Updated
2026-07-10
Healthy Volunteers
No
Interventions
Belzutifan
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
Nivolumab is administered intravenously at 480 mg until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Lenvatinib
Lenvatinib is administered orally at 20 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Cabozantinib
Cabozantinib is administered orally at 60 mg qd until PD, unacceptable toxicity, withdrawal of consent, death, investigator decision, or study termination.
Locations (44)
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
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
UZ Leuven ( Site 0900)
Leuven, Vlaams-Brabant, Belgium
Département clinique de médecine de laboratoire du CHUM ( Site 0001)
Montreal, Quebec, Canada
CIDO SpA ( Site 0305)
Temuco, Araucania, Chile
FALP ( Site 0300)
Santiago, Region M. de Santiago, Chile
Oncovida ( Site 0303)
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
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
Kyushu University Hospital ( Site 3101)
Fukuoka, Japan
Isala, locatie Zwolle ( Site 1902)
Zwolle, Overijssel, Netherlands
Auckland City Hospital ( Site 3000)
Auckland, New Zealand
Zakład Diagnostyki Laboratoryjnej, Centrum Onkologii ( Site 2000)
Bydgoszcz, Kuyavian-Pomeranian 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