Recruiting

Melphalan

Sponsor:

Massachusetts General Hospital

Code:

NCT07364474

Conditions

Uveal Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Melphalan through Percutaneous Hepatic Perfusion

Melphalan through Percutaneous Hepatic Perfusion in combination with Ipilimumab and Nivolumab

Study Details

Brief summary:

This study seeks to better understand the liver's immune response to receiving chemotherapy agent melphalan through Percutaneous Hepatic Perfusion (PHP) alone or in combination with Ipilimumab and Nivolumab for patients with Uveal Melanoma that has metastasized to the liver.

Conditions

Uveal Melanoma

Study ID

NCT07364474

Start date

Jan 27, 2026

Status verified date

Oct, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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
  • In Cohort B only: patient is determined to be a candidate for percutaneous hepatic perfusion with melphalan combined with Ipilimumab and Nivolumab
  • 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.
  • Prior 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Melphalan through Percutaneous Hepatic Perfusion (PHP)

Participants will receive PHP alone per standard of care.

active comparator: Melphalan through Percutaneous Hepatic Perfusion (PHP) in Combination with Ipilimumab and Nivolumab

Participants will receive PHP in combination with Ipilimumab and Nivolumab per standard of care.

Interventions

Melphalan through Percutaneous Hepatic Perfusion

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

Melphalan through Percutaneous Hepatic Perfusion in combination with Ipilimumab and Nivolumab

Melphalan through Percutaneous Hepatic Perfusion in combination with Ipilimumab and Nivolumab will be received as standard of care.

Primary outcome measure

  • Intratumoral CXCL13⁺ CD8⁺ T-cell infiltration following Percutaneous Hepatic Perfusion (PHP) or Percutaneous Hepatic Perfusion (PHP) in combination with Ipilimumab and Nivolumab. [ Time Frame: 3-4 weeks post treatment ]

Central Contacts and Locations

Central contacts

Aleigha Lawless

617-643-3578alawless@mgb.org

Juliane A Andrade Czapla

jczapla@mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Oct 23, 2026

Last verified

Oct, 2026

Keywords

  • Uveal Melanoma
  • Uveal Melanoma, Metastatic
  • Uveal Melanoma, Metastatic to liver

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2026-10-23. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.