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

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT07276386
Phase
PHASE2
Status
Recruiting
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Conditions

  • Metastatic Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Dec 31, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Sequential PHP with Melphalan/HDS followed by Tebentafusp
    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.

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Up to 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Jonathan Zager, MD, FACS (PRINCIPAL_INVESTIGATOR)
Joseph Markowitz, MD, PHD (SUB_INVESTIGATOR)
Nikhil Khushalani, MD (SUB_INVESTIGATOR)
Lilit Karapetyan, MD, MS (SUB_INVESTIGATOR)
Andrew Brohl, MD (SUB_INVESTIGATOR)
Zeynep Eroglu, MD (SUB_INVESTIGATOR)
Matthew Perez, MD (SUB_INVESTIGATOR)
Ahmad Tarhini, MD, PhD (SUB_INVESTIGATOR)

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By research site
Moffitt Cancer Center· Tampa, FL

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