Status:
ACTIVE_NOT_RECRUITING
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)
Lead Sponsor:
Peloton Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Conditions:
VHL - Von Hippel-Lindau Syndrome
VHL Gene Mutation
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 29 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03401788
Start Date
May 2 2018
End Date
March 29 2026
Last Update
December 3 2024
Active Locations (11)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
University of Michigan
Ann Arbor, Michigan, United States, 48109
4
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104