A Phase 2 Study of Belzutifan (PT2977, MK-6482) for the Treatment of Von Hippel Lindau (VHL) Disease-Associated Renal Cell Carcinoma (RCC) (MK-6482-004)
Running, not enrolling · Phase 2
Conditions studied: VHL - Von Hippel-Lindau Syndrome, VHL Gene Mutation, VHL Syndrome, VHL Gene Inactivation, VHL-Associated Renal Cell Carcinoma, VHL-Associated Clear Cell Renal Cell Carcinoma
In brief
This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.
Key facts
- Study ID
- NCT03401788
- Run by
- Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- People needed
- 50
- Starts
- 2018-05-02
- Expected to finish
- 2027-04-29
- Last updated by the study team
- 2026-04-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
- Has at least 1 measurable solid RCC tumor and no RCC tumor that requires immediate surgical intervention. The diagnosis of RCC can be radiologic (histologic diagnosis not required). Participants may have VHL disease-associated tumors in other organ systems
You may not qualify if…
- Has received prior treatment with belzutifan or another HIF-2α inhibitor
- Has had any systemic anti-cancer therapy (includes anti-vascular endothelial growth factor [VEGF] therapy or any systemic investigational anti-cancer agent)
- Has an immediate need for surgical intervention for tumor treatment
- Has evidence of metastatic disease on screening imaging
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University of Michigan — Ann Arbor, Michigan, United States
- University of Pennsylvania Medical Center — Philadelphia, Pennsylvania, United States
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
- Vanderbilt Medical Center — Nashville, Tennessee, United States
- MD Anderson Cancer Center — Houston, Texas, United States
- Huntsman Cancer Institute — Salt Lake City, Utah, United States
- Aarhus University Hospital — Aarhus, Denmark
- Hospital Georges Pompidou — Paris, France
- Cambridge University Hospital — Cambridge, United Kingdom
Full record on ClinicalTrials.gov
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