Own immune cells delivered to liver to fight melanoma
NCT ID NCT04812470
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This early-phase trial tested whether it is safe and feasible to give patients their own immune cells (called tumor infiltrating lymphocytes, or TIL) directly into the liver artery. Eight adults with melanoma that had spread to the liver received the TIL infusion along with chemotherapy and an immune booster. The main goal was to check for side effects and see if the approach is practical.
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 (TIL) plus melphalan and interleukin-2
- What this could lead to
- If it works, this could point toward a new way to treat melanoma that has spread to the liver using the patient's own immune cells.
- What could go wrong
- This is a very early phase 1 trial with only 8 people, so it is too small to prove effectiveness. The treatment involves strong chemotherapy and immune stimulation, which can cause serious side effects.
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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8 people
The number who actually took part.
- Started
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Feb 2023
- Finished
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May 2025
- 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: 1. Patients 18-75 years of age on the day of signing informed consent. 2. 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. 3. 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. 4. 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. 5. 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. 6. ECOG performance status of 0 - 2. 7. Female patient of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. 8. Female patients of childbearing potential must be willing to use a highly efficient method of contraception (Pearl index \<1), for the course of the study through 120 days after the last dose of study medication. 9. Male patients with women of childbearing potential partners must agree to use a condom for contraception, starting with the first dose of study therapy through 120 days after the last dose of study therapy. Exclusion Criteria: 1. Life expectancy of less than 3 months. 2. History of interstitial lung disease (ILD) or (non-infectious) pneumonitis. 3. Reduced renal function defined as S- Creatinine \>=1.5xULN or Creatinine Clearance \< 40 mL/min, calculated using the Cockroft and Gault formula. 4. Reduced hepatic function (defined as ASAT, ALAT, bilirubin \> 3\*ULN and PK- INR \> 1.5) or medical history of liver cirrhosis or portal hypertension. 5. Hemoglobin \<90 g/L or platelets \<100x109/L or neutrophils \<1.5x109/L 6. Use of live vaccines four weeks before or after the start of study. 7. History of severe hypersensitivity reactions to monoclonal antibodies. 8. Active infection. 9. Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C. 10. Active autoimmune disease or a history of known or suspected autoimmune disease. 11. 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. 12. Concomitant therapy with any other anti- cancer therapy, concurrent medical conditions requiring use of immunosuppressive medications or use of other investigational drugs. 13. Has a known additional malignancy of other diagnosis that is progressing or requires active treatment. 14. Pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study drug. 15. 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.
Contacts and locations
Locations
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Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
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