Phase 2 Sequential Treatment With Melphalan/HDS Via Percutaneous Hepatic Perfusion Followed by Tebentafusp in the Treatment of Metastatic Uveal Melanoma
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.
Arms & 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.
Outcome measures
Primary
Progression Free Survival (PFS)
PFS will be studied as time-to-event defined by the first documented disease progression or death due to any cause, whichever occurs first, from the start date of the study treatment. PFS will be determined based on tumor assessment (RECIST version 1.1 criteria).
Time frame: Up to 24 months
Secondary
Objective Response Rate (ORR)
Time frame: Up to 24 months
Clinical Benefit Rate (CBR)
Time frame: Up to 24 months
Hepatic PFS (hPFS)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Melanoma-Specific Survival (MSS)
Time frame: Up to 24 months
Time to Response (TTR)
Time frame: Up to 24 months
Duration of Response (DOR)
Time frame: Up to 24 months
Eligibility criteria
Study locations (1)
Moffitt Cancer Center
Tampa, Florida, 33612