NCT07364474 Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
| NCT ID | NCT07364474 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Uveal Melanoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2026-01-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2026-01-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.
Contact & Investigator
Eric Wehrenberg-Klee, MD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07364474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Uveal Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07364474 currently recruiting?
Yes, NCT07364474 is actively recruiting participants. Contact the research team at alawless@mgb.org for enrollment information.
Where is the NCT07364474 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07364474 clinical trial?
NCT07364474 is sponsored by Massachusetts General Hospital. The principal investigator is Eric Wehrenberg-Klee, MD at Massachusetts General Hospital. The trial plans to enroll 10 participants.
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