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: Active, not recruiting
• Trial end date: 2026-03-29
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peloton Therapeutics, Inc.

Criteria

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