NCT07276386

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

Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metastatic Uveal Melanoma

Interventions

Type	Name	Description
DRUG	Melphalan/HDS (Percutaneous Hepatic Perfusion)	3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter.
DRUG	Tebentafusp	20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter.

Timeline

• Start date: 2025-12-31
• Primary completion: 2030-12-01
• Completion: 2030-12-01
• First posted: 2025-12-11
• Last updated: 2026-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study