Melphalan + Tebentafusp for Eye Cancer

Overseen By Deanryan De Aquino

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jonathan Zager, MD, FACS

Principal Investigator

Moffitt Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with metastatic uveal melanoma (a type of eye cancer) that has spread to the liver. Participants must have a specific genetic marker, HLA-A*02:01, and should not have received certain prior treatments.

Inclusion Criteria

Ability to provide and understand written informed consent prior to any study procedures

Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required

I am fully active or can carry out light work.

Exclusion Criteria

My liver function is reduced, or I have a history of serious liver disease.

Hemoglobin <90 g/L or platelets <100x10^9/L or neutrophils <1.5x10^9/L

I do not have an active autoimmune disease needing strong medication, except for type-1 diabetes, eczema, or hypothyroidism.

What Are the Treatments Tested in This Trial?

Interventions

• Melphalan/HDS
• Tebentafusp

Trial Overview The study tests a two-step treatment for liver metastases from uveal melanoma. First, Melphalan/HDS via PHP targets the liver directly. Then Tebentafusp is used to help the immune system fight cancer cells.

How Is the Trial Designed?

Group I: Sequential PHP with Melphalan/HDS followed by Tebentafusp Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials

576

Recruited

145,000+

Delcath Systems Inc.

Industry Sponsor

Trials

11

Recruited

970+