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

NCT07364474 | Recruiting

• 1 other identifier: 25-679
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uveal Melanoma

Keywords

Uveal Melanoma; Uveal Melanoma, Metastatic; Uveal Melanoma, Metastatic to liver

Outcome Measures

Primary Outcomes (1)

• 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.

  3-4 weeks post treatment

Secondary Outcomes (5)

• Antigen-presenting cell (APC) populations and their activation state in the tumor microenvironment.

  28-42 day tumor biopsies

• T-cell infiltration in tumor and adjacent hepatic parenchyma.

  28-42 days post treatment

• Single-cell RNA sequencing derived frequency of macrophages and myeloid-derived suppressor cells (MDSCs)

  28-42 days post treatment

• Single-cell RNA sequencing derived phenotype of macrophages and myeloid-derived suppressor cells (MDSCs)

  28-42 days post treatment

• Immune cell populations with molecular and biochemical features of tissue and peripheral blood.

  28-42 days post treatment.

Study Arms (1)

Melphalan through Percutaneous Hepatic Perfusion

OTHER

Single arm

Drug: Melphalan through Percutaneous Hepatic Perfusion

Interventions

Melphalan through Percutaneous Hepatic Perfusion DRUG

Melphalan through Percutaneous Hepatic Perfusion will be received as standard of care,

Melphalan through Percutaneous Hepatic Perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Uveal Melanoma; Neoplasm Metastasis

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric Wehrenberg-Klee, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleigha Lawless

CONTACT

617-643-3578; alawless@mgb.org

Juliane A Andrade Czapla

CONTACT

jczapla@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dana-Farber/Harvard Cancer Center Investigator

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: January 23, 2026
• Study Start: January 27, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)