Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043)
Recruiting now · Phase 3
Conditions studied: Von Hippel-Lindau Disease, Malignant Neoplasms
In brief
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.
Key facts
- Study ID
- NCT07405164
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 450
- Starts
- 2026-03-23
- Expected to finish
- 2034-01-14
- Last updated by the study team
- 2026-08-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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 is running
- The Christie NHS Foundation Trust ( Site 2501) — Manchester, United Kingdom (enrolling)
- Dana-Farber Cancer Institute ( Site 0105) — Boston, Massachusetts, United States (enrolling)
- Karmanos Cancer Center ( Site 0108) — Detroit, Michigan, United States (enrolling)
- Hospital of the University of Pennsylvania Perelman Center for Advanced Medicine ( Site 0100) — Philadelphia, Pennsylvania, United States (enrolling)
- SCRI Oncology Partners ( Site 7000) — Nashville, Tennessee, United States (enrolling)
- START San Antonio ( Site 0104) — San Antonio, Texas, United States (enrolling)
- Fred Hutchinson Cancer Center ( Site 0106) — Seattle, Washington, United States (enrolling)
- St George Hospital-Oncology Clinical Research Unit ( Site 2701) — Kogarah, New South Wales, Australia (enrolling)
- Westmead Hospital ( Site 2703) — Sydney, New South Wales, Australia (enrolling)
- UZ Leuven ( Site 0900) — Leuven, Vlaams-Brabant, Belgium (enrolling)
- BP - A Beneficencia Portuguesa de São Paulo ( Site 0200) — São Paulo, São Paulo, Brazil (enrolling)
- James Lind Centro de Investigacion del Cancer ( Site 0304) — Temuco, Araucania, Chile (enrolling)
- CIDO SpA ( Site 0305) — Temuco, Araucania, Chile (enrolling)
- FALP ( Site 0300) — Santiago, Region M. de Santiago, Chile (enrolling)
- Oncovida ( Site 0303) — Santiago, Region M. de Santiago, Chile (enrolling)
- Bradfordhill ( Site 0301) — Santiago, Region M. de Santiago, Chile (enrolling)
- ONCOCENTRO APYS ( Site 0302) — Viña del Mar, Valparaiso, Chile (enrolling)
- Fakultni nemocnice Olomouc-Onkologicka klinika ( Site 1000) — Olomouc, Czechia (enrolling)
- Herlev and Gentofte Hospital ( Site 1200) — Herlev, Capital Region, Denmark (enrolling)
- Tampereen yliopistollinen sairaala ( Site 1305) — Tampere, Pirkanmaa, Finland (enrolling)
- Hôpitaux Universitaires de Strasbourg ( Site 1702) — Strasbourg, Bas-Rhin, France (enrolling)
- Institut Claudius Regaud ( Site 1703) — Toulouse, Haute-Garonne, France (enrolling)
- Országos Onkológiai Intézet-Urogenitális Tumorok és Klinikai Farmakológiai Osztály ( Site 1501) — Budapest, Hungary (enrolling)
- Rambam Health Care Campus ( Site 1600) — Haifa, Israel (enrolling)
- Hadassah Medical Center ( Site 1604) — Jerusalem, Israel (enrolling)
Full record on ClinicalTrials.gov
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