NCT03401788

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)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Belzutifan	120 mg once daily (three 40 mg oral tablets once daily).

Timeline

• Start date: 2018-05-02
• Primary completion: 2027-04-29
• Completion: 2027-04-29
• First posted: 2018-01-17
• Last updated: 2026-04-13

Locations

11 sites across 4 countries: United States, Denmark, France, United Kingdom

Regulatory

• FDA-regulated drug study