Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07276386 | Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma | PHASE2 | RECRUITING | 18 | — | — | Dec 31, 2025 | Dec 1, 2030 | Mar 31, 2026 | 1 | United States |
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).
| Arm | Type | Description |
|---|---|---|
| Sequential PHP with Melphalan/HDS followed by Tebentafusp | EXPERIMENTAL | Patients will undergo two percutaneous hepatic perfusion (PHP) procedures with melphalan/HDS, spaced 6-8 weeks apart. Tebentafusp will be initiated within 6 weeks (+/- 2 weeks) after the second PHP and administered weekly for 1 year. Additional PHP procedures (up to 6 total) may be performed as standard of care if disease progression occurs while on tebentafusp. |
| Name | Type | Description |
|---|---|---|
| Melphalan/HDS (Percutaneous Hepatic Perfusion) | DRUG | 3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter. |
| Tebentafusp | DRUG | 20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter. |
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 ...