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Immune Response to Melphalan for Uveal Melanoma in the Liver

This study is looking at how your body's immune system responds to a chemotherapy drug called melphalan when it's delivered directly to the liver. This treatment, called Percutaneous Hepatic Perfusion (PHP), is for people with uveal melanoma (a type of eye cancer) that has spread to the liver. Researchers want to see if this treatment increases a specific type of immune cell (CXCL13+ CD8+ T-cells) within the tumor. You might be able to join if you are an adult with uveal melanoma that has spread to your liver and your doctor thinks PHP with melphalan is a good treatment option for you. The study plans to enroll 10 participants. The current status of this study is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 10 participants.
What's involved
You will have biopsies and blood samples taken before treatment. You will then receive one dose of melphalan through Percutaneous Hepatic Perfusion (PHP), and return 3-4 weeks later for another biopsy and blood draw.
Compensation
Not stated in the trial record.
Follow-up
You will have a follow-up biopsy and blood draw 3-4 weeks after treatment.

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NCT07364474

Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver

Recruiting
NAAges 18+Interventional
Massachusetts General Hospital
~10 participants
Updated 2026-03-11 on ClinicalTrials.gov
What's tested:Melphalan through Percutaneous Hepatic Perfusion

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)
Measured over 3-4 weeks post treatment

Conditions

Uveal Melanoma

Explore related trials

Uveal Melanoma

Where it's being run

1 sites across 1 states
Massachusetts1

Study leadership

  • Eric Wehrenberg-Klee, MD · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

Aleigha Lawless
[email protected]
617-643-3578
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Patient has histologically or cytologically confirmed diagnosis of uveal melanoma metastatic to the liver and is determined to be a candidate for percutaneous hepatic perfusion with melphalan
The subject has read, signed and dated the Informed Consent Form (ICF), having been advised of the risks and benefits of the trial in a language understood by the subject.
Age \> 18 years at date of informed consent signature having the ability to comply with the protocol.
Contrast-enhanced cross-sectional imaging of the abdomen (either CT or MRI) obtained within two months prior to study enrollment
Measurable metastatic disease. Subject must have at least one site of metastatic disease ≥ 1 cm in size and amenable to percutaneous image-guided biopsy
Life expectancy \> 12 weeks.
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Laboratory requirements:
Absolute neutrophil count (ANC) \> 1 x 109/L
Platelets \> 75 x 109/L
Alanine aminotransferase (ALT) / Aspartate aminotransferase (AST) \< 5 x ULN
Total bilirubin \<3 mg/dL
International normalized ratio (INR) \<1.7
Glomerular filtration rate (GFR) \>30 ml/min

Exclusion

Lesion to undergo biopsy cannot have undergone prior radiation therapy or other locoregional therapy
Continued adverse events from a previously administered chemotherapeutic agents. Grade 1 adverse events and ongoing toxicities such as alopecia are exempt
Treatment with systemic corticosteroids exceeding the equivalent of 10 mg/day of prednisone or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, and anti-tumor necrosis factor \[anti-tumor necrosis factor (TNF)\] agents) within 2 weeks prior to Day 1, or anticipated requirement for systemic immunosuppressive medications exceeding the equivalent of 10 mg/day of prednisone during the trial
Patients who receive acute, low-dose, systemic corticosteroid medications (e.g., a one-time dose of dexamethasone for nausea) or for prevention of hypersensitivity reactions to contrast agents may be enrolled in the trial.
Anticoagulant or anti-platelet medication that cannot be interrupted prior to biopsy
Pregnant or lactating
Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicated the use of an investigational drug or that could affect the interpretation of the results or render the patient at high risk from treatment complications.
Treatment with systemic immunostimulatory agents (including but not limited to interferon(IFN)s, interleukin \[IL\]-2) within 6 weeks or five half- lives of the drug, whichever was shorter, prior to Day 1.
Treatment with immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, anti-LAG-3 antibodies, within the past three months. Prior treatment with tebentafusp is allowed with no washout period required.
Treatment with any investigational systemic medication within at least one month prior to biopsy. If an investigational agent is an immune checkpoint inhibitor, a three-month washout is required. Prior treatment with Darovasertib and Crizotinib is allowed with no washout period required.
Signs or symptoms clinically significant of infection within 2 weeks prior to Day 1.

What this trial measures

  • Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)3-4 weeks post treatment

    Change in the percentage of CXCL13⁺ CD8⁺ T cells in tumor biopsies between Day 0 (pre-treatment) and Day 28-42 (approximately 3-4 weeks post-treatment), as measured by single-cell RNA sequencing.