Melphalan/HDS and Tebentafusp for Uveal Melanoma

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

Recruiting Phase 2 Interventional Study
Metastatic Uveal Melanoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
18 (estimated)
Sponsor
H. Lee Moffitt Cancer Center and Research Institute · Other
Who this trial is looking for

This trial is looking for adults with metastatic uveal melanoma that has spread to the liver. Participants will receive treatments involving specific medications and procedures to help manage their condition.

Are You a Good Fit for This Trial?
Rules you out Severe COPDHeart failureLiver cirrhosisHIVHepatitis BHepatitis C

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with metastatic uveal melanoma that has spread to my liver.
  • I have a specific genetic marker called HLA-A*02:01.
  • I have measurable disease in my liver.
  • I am physically able to undergo the proposed treatments.
  • I can provide informed consent.
  • I am a woman of childbearing potential and have had a negative pregnancy test.
  • I am a man of childbearing potential and agree to use contraception.

You may not be able to join if

  • I expect to live less than 6 months.
  • More than half of my liver is affected by cancer.
  • I have significant heart problems.
  • I have serious lung disease that prevents me from being anesthetized.
  • I cannot be given general anesthesia.
  • I have severe liver or kidney problems.
  • I have a history of severe reactions to melphalan, heparin, or iodine contrast.
  • I am pregnant, breastfeeding, or planning to conceive.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About 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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Patient is ≥18 years of age on the day of signing informed consent. * ECOG performance status of 0 or 1. * Histologically or cytologically confirmed liver metastasis of uveal melanoma. * HLA-A\*02:01 positive status. * Measurable disease by computed tomography (CT) per RECIST …
Contacts

Deanryan De Aquino

813-745-3998

Deanryan.Deaquino@moffitt.org

CONTACT