Phase 2 Study of Sequential Treatment with MelphalanHDS via Percutaneous Hepatic Perfusion Followed by Tebentafusp for Metastatic Uveal Melanoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a sequential treatment approach for patients with metastatic uveal melanoma that has spread only to the liver. This Phase 2 study focuses on patients who are positive for HLA-A*0201 and aims to see if percutaneous hepatic perfusion PHP with melphalanHDS followed by tebentafusp can improve outcomes by enhancing tumor antigen release and immune response. The study is led by the H. Lee Moffitt Cancer Center and Research Institute. Participants will first receive two PHP treatments delivering melphalanHDS directly to the liver through a catheter, spaced 6 to 8 weeks apart. After these treatments, tebentafusp will be started within 6 weeks and given weekly for one year. If the disease progresses during tebentafusp treatment, up to four additional PHP procedures may be administered as part of standard care. The melphalan dose is based on ideal body weight, and tebentafusp dosing begins with increasing amounts before settling into a weekly routine. Throughout the study, participants will undergo regular assessments to track disease progression using imaging and clinical evaluations. The primary measure is progression-free survival over up to 24 months. Secondary measures include response rates, clinical benefit, liver-specific progression, overall survival, and time and duration of response. Safety monitoring and follow-up will continue as scheduled to understand the treatment effects and tolerability over time. Total participation may last up to two years depending on individual patient response and treatment course.

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