NCT07276386 Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma

Trial Parameters

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Brief 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 Criteria

Inclusion Criteria: * Patient is ≥18 years of age on the day of signing informed consent. * ECOG performance status of 0 or 1. * Histologically or cytologically confirmed liver metastasis of uveal melanoma. * HLA-A\*02:01 positive status. * Measurable disease by computed tomography (CT) per RECIST 1.1 with at least one target lesion identified in the liver. * Patient deemed suitable for PHP and tebentafusp. * Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. * Female patients of childbearing potential must be willing to use an adequate method of contraception, for the course of the study through 150 days after the last dose of study medication. Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject. * Male patients of childbearing p

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