Locoregional or Systemic Administration of Autologous Tumor Infiltrating Lymphocytes in Patients With Metastatic Melanoma

NCT07183852 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: GoTIL_2025EU
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Metastatic Uveal Melanoma; Metastatic Cutaneous Melanoma

Keywords

Adoptive Cell Therapy; Tumor Infiltrating Lymphocyte; Hepatic Arterial Infusion; Melphalan; Interleukin-2

Outcome Measures

Primary Outcomes (1)

• 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

  5 years

Secondary Outcomes (6)

• Objective response rate (ORR)

  2 years

• Progression free-survival (PFS)

  2 years

• hepatic Progression-free survival (hPFS)

  2 years

• Duration of objective response (DOR)

  2 years

• Overall Survival (OS)

  5 years

Study Arms (2)

Cohort 1

EXPERIMENTAL

Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI

Drug: Autologous Tumor Infiltrating Lymphocytes (TIL); Drug: Melphalan; Drug: Interleukin-2

Cohort 2

EXPERIMENTAL

Patients With Cutaneous Melanoma and visceral metastases, IV admin

Drug: Autologous Tumor Infiltrating Lymphocytes (TIL); Drug: Melphalan; Drug: Interleukin-2

Interventions

Autologous Tumor Infiltrating Lymphocytes (TIL) DRUG

Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion

Cohort 1; Cohort 2

Melphalan DRUG

1 mg/kg, IV

Cohort 1; Cohort 2

Interleukin-2 DRUG

2 MIU, subcutaneous twice daily for up to 14 days.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

MeSH Terms

Conditions

Uveal Melanoma; Melanoma

Interventions

Melphalan; Interleukin-2

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases; Skin Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Lymphokines; Proteins; Biological Factors

Central Study Contacts

Lars Ny, PhD

CONTACT

+46 31 342 40 11; lars.ny@vgregion.se

Axel Nelson, PhD

CONTACT

+46 31 342 40 11; axel.nelson@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cohort 1 Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI Cohort 2 Patients With Cutaneous Melanoma and visceral metastases, IV admin

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 19, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2033
• Last Updated: September 19, 2025

Record last verified: 2025-09