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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)
Trial Status: closed to accrual
This study is designed to investigate belzutifan as a treatment for VHL disease
associated RCC.
Inclusion Criteria
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
Exclusion Criteria
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
Additional locations may be listed on ClinicalTrials.gov for NCT03401788.
Locations matching your search criteria
United States
Connecticut
New Haven
Yale University
Status: Approved
Name Not Available
Utah
Salt Lake City
Huntsman Cancer Institute/University of Utah
Status: Active
Name Not Available
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.
Trial PhasePhase II
Trial Typetreatment
Lead OrganizationPeloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
