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

6482-004

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

2018-05-02

2026-03-29

2026-03-29

Active (not recruiting)

Early phase I

50

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Phase 2 Open Label', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-02-20