drugset / Trial / NCT07276386
Phase 2 Combination of Melphalan/HDS Via PHP + Tebentafusp in Treating Metastatic Uveal Melanoma
Phase 2
Recruiting
18 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Delcath Systems Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-12-31
- Primary completion
- 2030-12
- Completion
- 2030-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Melphalan | Small molecule | 3 mg/kg | Other |
| Subject | Tebentafusp | Protein / enzyme biologic | 68 ug | Intravenous |