Metastatic Uveal MelanomaPhase 1GoTIL-01NCT07183852
Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma
A Phase 1 study testing Autologous Tumor Infiltrating Lymphocytes (TIL), Melphalan and Interleukin-2 in people with Metastatic Uveal Melanoma and Metastatic Cutaneous Melanoma, run by Vastra Gotaland Region.
Trial summary
The purpose of this study is to evaluate the feasibility, safety and tolerability of locoregional or systemic administration of autologous tumor infiltrating lymphocytes in patients with metastatic melanoma Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Metastatic Uveal Melanoma, Metastatic Cutaneous Melanoma
- What is being tested?
- Autologous Tumor Infiltrating Lymphocytes (TIL), Melphalan and Interleukin-2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Mar 2033
- Phase
- Phase 1
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be at least 18 years of age.
- Can provide a signed informed consent as described in the protocol, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
- World Health Organization (WHO) Performance Status 0 or 1.
- Patient must have a histologically/cytologically confirmed diagnosis of:
- stage IV uveal melanoma with confirmed progression following prior systemic therapy with tebentafusp (if HLA A2:01 positive) OR
- stage IV cutaneous melanoma with confirmed progression following prior systemic therapy with a programmed cell death protein-1 (PD-1) inhibitor with or without a CTLA-4 inhibitor
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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 to generate TILs.
- Measurable disease by computed tomography (CT) per RECIST 1.1 criteria after resection of lesion for TILs production
- No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.
- 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
- Any serious or uncontrolled medical conditions that, in the investigator's opinion, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy (including operation), or interfere with the interpretation of study results.
- Subjects with 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.
- Women who are pregnant or breastfeeding.
- Any condition that potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to evaluate the feasibility, safety and tolerability of locoregional or systemic administration of autologous tumor infiltrating lymphocytes in patients with metastatic melanoma
- Being tested
- Autologous Tumor Infiltrating Lymphocytes (TIL), Melphalan, Interleukin-2
- Keywords
- Adoptive Cell Therapy, Tumor Infiltrating Lymphocyte, Hepatic Arterial Infusion, Melphalan, Interleukin-2
- 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 Lymphocytes (TIL)Drug
Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion
MelphalanDrug
1 mg/kg, IV
Interleukin-2Drug
2 MIU, subcutaneous twice daily for up to 14 days.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI Receives: Drug: Autologous Tumor Infiltrating Lymphocytes (TIL); Drug: Melphalan; Drug: Interleukin-2 |
| Cohort 2 | Experimental | Patients With Cutaneous Melanoma and visceral metastases, IV admin Receives: Drug: Autologous Tumor Infiltrating Lymphocytes (TIL); Drug: Melphalan; Drug: Interleukin-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Measured: 5 years
Secondary outcomes (6)
Objective response rate (ORR)
RECIST 1.1
Measured: 2 years
Progression free-survival (PFS)
Evaluation of Progression-free survival
Measured: 2 years
hepatic Progression-free survival (hPFS)
Evaluation of hepatic Progression-free survival
Measured: 2 years
Duration of objective response (DOR)
Evaluation of duration of a response by RECIST 1.1
Measured: 2 years
Overall Survival (OS)
Evaluation of Overall Survival
Measured: 5 years
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.
- First posted19 Sep 2025
- Study startJan 2027 (estimated)
- Primary completionMar 2028 (estimated)
- Study completionMar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Uveal MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Cohort 1 Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI Cohort 2 Patients With Cutaneous Melanoma and visceral metastases, IV admin
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183852
- Sponsor's protocol ID
- GoTIL_2025EU
- Acronym
- GoTIL-01
- Status last verified
- Sep 2025
- First submitted
- 12 Sep 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided