Von Hippel-Lindau Disease Clinical Trial
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)
This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.
This open-label Phase 2 study will evaluate the efficacy and safety of belzutifan in participants with VHL disease who have at least 1 measurable RCC tumor. Belzutifan will be administered orally and treatment will be continuous. Participants will be evaluated radiologically approximately 12 weeks after initiation of treatment and every 12 weeks thereafter while continuing in the study for a minimum of 3 years and then every 24 weeks or more frequently if clinically indicated. Changes in VHL disease-associated non-RCC tumors will also be evaluated.
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
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
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There are 8 Locations for this study
Bethesda Maryland, 20892, United States
Boston Massachusetts, 02114, United States
Ann Arbor Michigan, 48109, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15232, United States
Nashville Tennessee, 37232, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84112, United States
Aarhus , , Denmark
Paris , , France
Cambridge , , United Kingdom
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