Liver-Targeted immune cell attack tested against melanoma spread
NCT ID NCT05903937
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing a treatment for melanoma that has spread to the liver. They collect tumor-infiltrating lymphocytes, a type of immune cell, from the patient's own tumor and grow them in the lab. Before returning the cells, they use a technique called percutaneous hepatic perfusion to send the chemotherapy drug melphalan directly to the liver. The cells are then infused into the liver's blood supply, followed by low-dose interleukin-2 to support them. The trial's main goal is to see whether this approach is safe and tolerable in a small group of patients with stage IV uveal or cutaneous melanoma.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous tumor infiltrating lymphocytes (a patient's own immune cells), given with melphalan chemotherapy and low-dose interleukin-2
- What this could lead to
- If it works, this could offer a way to control melanoma that has spread to the liver, a site where current treatments often stop working.
- What could go wrong
- This is a very small Phase 1 trial focused first on safety, so it may show the approach is too toxic or not effective. Liver-directed chemotherapy and cell therapy carry real risks, and results in a few patients may not apply broadly.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2027
An estimate. Start dates often move.
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient is willing and able to provide written informed consent and comply with study procedures. Written informed consent must be signed and dated before the start of specific protocol procedures. * Patient must have a histologically/cytologically confirmed diagnosis of: * stage IV uveal melanoma with or without any previous systemic therapy OR * stage IV cutaneous melanoma with confirmed progression following at least one or two prior systemic therapies including a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor; and if BRAF V600 mutation-positive, also a BRAF inhibitor or a BRAF inhibitor in combination with a MEK inhibitor. * Measurable disease by computed tomography (CT) per RECIST 1.1 criteria with at least one target lesion identified in the liver and where the distribution pattern of metastasis is predominantly engaging the liver as judged by the investigator. * At least one resectable lesion in the liver (or aggregate of lesions resected) of a minimum size of 0.5 cm in diameter post- resection to generate TILs. * ECOG performance status of 0 - 1. Exclusion Criteria: * Life expectancy of less than 3 months. * Reduced renal function defined as S-Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula. * Reduced hepatic function (defined as ASAT, ALAT, bilirubin \> 3\*ULN and PK- INR \> 1.5) or medical history of liver cirrhosis or portal hypertension. * Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L * Use of live vaccines four weeks before or after the start of study. * Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C. * Active autoimmune disease. * A condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses \>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease. * Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs. * Has a known additional malignancy of other diagnosis that is progressing or requires active treatment. * A history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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