Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma
H. Lee Moffitt Cancer Center and Research Institute
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 can…
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.
Location
- Moffitt Cancer CenterTampa, Florida