Phase 2 Study of Melphalan/HDS and Tebentafusp for Treating Metastatic Uveal Melanoma

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Sponsor score: 40

ClinicalTrials ID:NCT07276386

Provider View

This clinical trial is testing a new treatment approach for patients with metastatic uveal melanoma that has spread to the liver. The study combines a liver-targeted chemotherapy procedure with an immunotherapy drug to see if it can improve outcomes for patients with this type of cancer.

Patient Parameters

Program Overview

The study aims to evaluate the effectiveness and safety of a two-step treatment for patients with metastatic uveal melanoma that has spread to the liver. The treatment involves a procedure called percutaneous hepatic perfusion (PHP) using the drug melphalan, followed by the immunotherapy drug tebentafusp. This approach is being tested to see if it can help the immune system better target and attack the cancer in patients who have a specific genetic marker (HLA-A*02:01).

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a good performance status, meaning you are fully active or have some restrictions but can still do light work.
  • Have liver metastasis from uveal melanoma confirmed by tests.
  • Have the HLA-A*02:01 genetic marker.
  • Have at least one measurable liver tumor as seen on a CT scan.
  • Be suitable for the PHP procedure and tebentafusp treatment.
  • Women of childbearing potential must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 150 days after the last treatment.
  • Men must agree to use effective birth control during the study and for 150 days after the last treatment.
  • May have limited cancer outside the liver that can be treated before starting tebentafusp.
  • Must be able to understand and sign a consent form before participating.

Exclusion Criteria

  • Life expectancy of less than 6 months.
  • More than 50% of the liver affected by tumors.
  • Cancer outside the liver that cannot be treated before starting the study.
  • Serious heart conditions or lung diseases that prevent the use of general anesthesia.
  • Unable to undergo general anesthesia for any reason.
  • Poor kidney or liver function as indicated by specific blood tests.
  • Low blood cell counts.
  • Recent use of live vaccines.
  • Severe allergic reactions to study drugs or contrast agents, unless manageable with pre-medication.
  • Infections like HIV, hepatitis B, or hepatitis C.
  • Active autoimmune diseases requiring treatment, except for certain conditions like type-1 diabetes.
  • Use of high-dose steroids or other immunosuppressive drugs recently.
  • Receiving other cancer treatments or investigational drugs.
  • Have another progressing cancer that needs treatment.
  • Pregnant or breastfeeding, or planning to conceive during the study period.
  • Any condition or treatment that could interfere with the study or is not in the patient's best interest.
  • Previous treatment with PHP or tebentafusp.

Locations

FACILITYZIPCITYSTATE
Moffitt Cancer Center33612TampaFlorida

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