This study seeks to better understand the liver's immune response to receiving chemotherapy agent melphalan through Percutaneous Hepatic Perfusion (PHP) for patients with Uveal Melanoma that has metastasized to the liver.
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
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.
Single group
Melphalan through Percutaneous Hepatic Perfusion
DrugMelphalan through Percutaneous Hepatic Perfusion will be received as standard of care,
Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP)
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.
Antigen-presenting cell (APC) populations and their activation state in the tumor microenvironment.
Comparison of proportions and activation markers of dendritic cells and other APC subsets in pre-treatment (Day 0) and post-treatment (Day 28-42) tumor biopsies.
T-cell infiltration in tumor and adjacent hepatic parenchyma.
Change in FOXP3⁺ regulatory T-cell infiltration between pre-treatment (Day 0) and post-treatment (Day 28-42) tumor and parenchymal biopsies.
Single-cell RNA sequencing derived frequency of macrophages and myeloid-derived suppressor cells (MDSCs)
Change in the frequency of macrophages and myeloid-derived suppressor cells (MDSCs) between pre-treatment (Day 0) and post-treatment (Day 28-42) samples as assessed by single-cell RNA sequencing.
Single-cell RNA sequencing derived phenotype of macrophages and myeloid-derived suppressor cells (MDSCs)
Change in the phenotype of macrophages and myeloid-derived suppressor cells (MDSCs) between pre-treatment (Day 0) and post-treatment (Day 28-42) samples.
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