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Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma

StatusRecruiting
PhasePhase 2
Started2025-12-31
View on ClinicalTrials.gov ↗

Amendment history

2026-03-26
minor
Study Status v1
Start dateestimated 2025-12→confirmed 2025-12-31
2025-12-01
minor
Original filing
This Phase 2 study evaluates the efficacy and safety of sequential treatment with percutaneous hepatic perfusion (PHP) using melphalan/HDS followed by tebentafusp in patients with metastatic uveal melanoma (mUM) with isolated liver metastases. The rationale is that PHP enhances antigen release and immunomodulation, potentially sensitizing tumors to tebentafusp in HLA-A\*02:01-positive patients.
Trial Details
NCT Number NCT07276386
Lead Sponsor H. Lee Moffitt Cancer Center and Research Institute
Collaborators: Delcath Systems Inc.
Conditions Metastatic Uveal Melanoma
Enrollment 18 participants
Start Date 2025-12-31
Primary Completion 2030-12 (estimated)
Study Completion 2030-12 (estimated)
Updated on ClinicalTrials.gov 2026-03-31