Actively Recruiting
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Led by Massachusetts General Hospital · Updated on 2026-03-11
10
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Immune Response to Percutaneous Hepatic Perfusion With Melphalan for Ocular Melanoma Metastatic to the Liver
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed uveal melanoma metastatic to the liver and candidate for percutaneous hepatic perfusion with melphalan
- Signed informed consent form after being informed about the trial risks and benefits
- Age over 18 years with ability to follow the study protocol
- Contrast-enhanced CT or MRI of the abdomen within two months before enrollment
- At least one measurable metastatic liver lesion 1 cm or larger suitable for image-guided biopsy
- Life expectancy greater than 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Absolute neutrophil count (ANC) greater than 1 x 10^9/L
- Platelet count greater than 75 x 10^9/L
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than 5 times the upper limit of normal
- Total bilirubin less than 3 mg/dL
- International normalized ratio (INR) less than 1.7
- Glomerular filtration rate (GFR) greater than 30 ml/min
You will not qualify if you...
- Liver lesion to be biopsied has received prior radiation or locoregional therapy
- Persistent adverse events from previous chemotherapy, except grade 1 events like hair loss
- Use of systemic corticosteroids above 10 mg/day prednisone equivalent or other immunosuppressive drugs within 2 weeks before Day 1, or planned use during the trial
- Use of anticoagulant or antiplatelet medications that cannot be stopped before biopsy
- Pregnant or breastfeeding
- Any other medical condition or lab abnormality that may increase risk or affect results
- Use of systemic immunostimulatory agents within 6 weeks or five half-lives before Day 1
- Use of immune checkpoint therapies (anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-LAG-3) within 3 months; prior tebentafusp allowed without washout
- Use of investigational systemic drugs within 1 month before biopsy, except some drugs allowed without washout
- Signs or symptoms of infection within 2 weeks before Day 1
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
A
Aleigha Lawless
CONTACT
J
Juliane A Andrade Czapla
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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