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Own immune cells delivered to liver to fight melanoma

NCT ID NCT04812470

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

8 people

The number who actually took part.

Started

Feb 2023

Finished

May 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Department of Oncology, Sahlgrenska University Hospital

    Gothenburg, Sweden

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