Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

Official Title: An Open-Label Phase 2 Study to Evaluate PT2977 for the Treatment of Von Hippel Lindau Disease-Associated Renal Cell Carcinoma

Study ID: NCT03401788

Conditions

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

Interventions

Belzutifan

Study Description

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

Detailed Description: 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.