Not yet recruiting NCT07183852
Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Tumor Infiltrating Lymphocytes (TIL), Melphalan, Interleukin-2.
- Who it may be relevant to
- Registry conditions: Metastatic Uveal Melanoma, Metastatic Cutaneous Melanoma. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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
Interventions
- Drug Autologous Tumor Infiltrating Lymphocytes (TIL)
Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion - Drug Melphalan
1 mg/kg, IV - Drug Interleukin-2
2 MIU, subcutaneous twice daily for up to 14 days.
Primary outcome measures
- Incidence and severity of adverse events [Time frame: 5 years]
Secondary outcome measures (6)
- Objective response rate (ORR) [Time frame: 2 years]
- Progression free-survival (PFS) [Time frame: 2 years]
- hepatic Progression-free survival (hPFS) [Time frame: 2 years]
- Duration of objective response (DOR) [Time frame: 2 years]
- Overall Survival (OS) [Time frame: 5 years]
- Evaluation of feasibility of an automated production of TILs [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07183852 · GoTIL_2025EU