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)

VHL Syndrome Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Syndrome
• VHL - Von Hippel-Lindau Syndrome
• VHL Gene Inactivation
• VHL Gene Mutation
• VHL Syndrome
• VHL-Associated Clear Cell Renal Cell Carcinoma
• VHL-Associated Renal Cell Carcinoma
• Von Hippel-Lindau Disease

• NCT number: NCT03401788
• Study type: Interventional
• Source: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: May 2, 2018
• Completion date: March 29, 2026