RecruitingPhase 2NCT07276386

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


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

18 participants

Start Date

Dec 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of two treatments — a liver-targeted chemotherapy delivery method (called PHP with melphalan) and an immunotherapy drug called tebentafusp — for patients with uveal melanoma (a rare eye cancer) that has spread to the liver. **You may be eligible if...** - You are 18 or older - You have uveal melanoma that has spread to the liver, confirmed by biopsy - You have a specific genetic marker called HLA-A*02:01 - Your liver is not too heavily taken over by tumor (less than 50% of liver volume) - You are in good physical condition (ECOG 0 or 1) - You have adequate blood counts and organ function **You may NOT be eligible if...** - More than half your liver is replaced by tumor - You have significant spread of cancer outside the liver (beyond what can be treated with radiation or surgery) - You have serious heart or lung conditions that prevent general anesthesia - You have liver cirrhosis or seriously impaired liver function - You have HIV, hepatitis B, or hepatitis C - You have active autoimmune disease requiring immune-suppressing drugs - You are pregnant or breastfeeding - You have already been treated with PHP or tebentafusp Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMelphalan/HDS (Percutaneous Hepatic Perfusion)

3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter.

DRUGTebentafusp

20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT07276386


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