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)

Status: closed to accrual

This study is designed to investigate belzutifan as a treatment for VHL disease associated RCC.

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

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.

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