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

NCT07276386 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-03-31

No results posted yet for this study

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.

Conditions

  • Metastatic Uveal Melanoma

Interventions

DRUG

Melphalan/HDS (Percutaneous Hepatic Perfusion)

3 mg/kg ideal body weight (max 220 mg) infused via hepatic artery catheter.

DRUG

Tebentafusp

20 mcg IV day 1, 30 mcg day 8, 68 mcg day 15, then weekly thereafter.

Sponsors & Collaborators

  • Delcath Systems Inc.

    collaborator INDUSTRY

  • H. Lee Moffitt Cancer Center and Research Institute

    lead OTHER

Principal Investigators

  • Jonathan Zager, MD, FACS · Moffitt Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-31
Primary Completion
2030-12-31
Completion
2030-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07276386 on ClinicalTrials.gov