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Metastatic Uveal MelanomaPhase 1HAITILSNCT04812470

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2 in people with Metastatic Uveal Melanoma and Metastatic Cutaneous Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteSweden
Study dates
6 Feb 2023to 26 May 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18-75 years of age on the day of signing informed consent.
  • 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.
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  • 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 - 2.
  • 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.
  • 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.
  • 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.

Who cannot join

  • Life expectancy of less than 3 months.
  • History of interstitial lung disease (ILD) or (non-infectious) pneumonitis.
  • 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.
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  • History of severe hypersensitivity reactions to monoclonal antibodies.
  • Active infection.
  • Infection of human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), hepatitis B or hepatitis C.
  • Active autoimmune disease or a history of known or suspected 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Department of Oncology, Sahlgrenska University Hospital

    Gothenburg

Other trials in Sweden

About this study

Official title: A Phase I Study Using Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases

The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.

Being tested
Autologous Tumor Infiltrating Lymphocytes, Melphalan, Interleukin-2
Keywords
Adoptive Cell Transfer, Lymphocytes, Tumor-Infiltrating, Interleukin-2, Melphalan, Antineoplastic Agents, Immunological, Hepatic arterial infusion, bioreactor
Medical subject headings
Uveal Melanoma, Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Autologous Tumor Infiltrating LymphocytesDrug

    Administered via hepatic arterial infusion

  • MelphalanDrug

    Melphalan will be administered once as an intravenous infusion.

  • Interleukin-2Drug

    After TIL infusion, Interleukin-2 will be administered subcutaneously once daily for up to 14 days.

Study groups in NCT04812470
Study groupRoleWhat they receive
Autologous tumor infiltrating lymphocytes (TIL)ExperimentalAutologous TIL administered via hepatic arterial infusion followed by low dose Interleukin-2 after preconditioning chemotherapy with Melphalan.
Receives: Drug: Autologous Tumor Infiltrating Lymphocytes; Drug: Melphalan; Drug: Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)

    Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0

    Measured: 5 years from start of chemotherapy

Secondary outcomes (7)

  1. Objective response rate (ORR)

    Defined by RECIST 1.1

    Measured: 2 years from start of chemotherapy

  2. Clinical benefit rate (CBR)

    Defined by RECIST 1.1

    Measured: 18 weeks

  3. Progression free survival (PFS)

    Evaluation of progression-free survival

    Measured: 2 years

  4. hepatic Progression free survival (hPFS)

    Evaluation of hepatic progression-free survival

    Measured: 2 years

  5. Duration of objective response (DOR)

    Evaluation of duration of response

    Measured: 2 years

  6. Overall Survival (OS)

    Evaluation of overall survival

    Measured: 5 years

  7. Evaluation of feasibility of an automated production of TILs

    Defined as the proportion of patients included that receive treatment with the TIL product.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2021
  2. Study start6 Feb 2023
  3. Primary completion26 May 2025
  4. Study completion26 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
dose escalation
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04812470
Sponsor's protocol ID
2020-006126-31
Acronym
HAITILS
Status last verified
Sep 2025
First submitted
5 Mar 2021
Last updated
22 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nelson A, Riise R, Alsen S, Wong A, Carlson P, Edman S, Holgersson J, Olofsson Bagge R, Johansson I, Sadik M, Edenbrandt L, Nilsson LM, Nilsson JA, Ny L. Phase I trial of locoregional administration of autologous tumor-infiltrating lymphocytes in patients with uveal melanoma and liver metastases (the HAITILS trial). J Immunother Cancer. 2026 Mar 18;14(3):e014401. doi: 10.1136/jitc-2025-014401.

    PubMed 41850738

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes, Melphalan and Interleukin-2 in people with Metastatic Uveal Melanoma and Metastatic Cutaneous Melanoma, run by Vastra Gotaland Region at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) (time frame: 5 years from start of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04812470, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.

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