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

Not Applicable

Not yet recruiting

• Conditions: Metastatic Uveal Melanoma; Metastatic Cutaneous Melanoma
• Interventions: Drug: Autologous Tumor Infiltrating Lymphocytes (TIL); Drug: Melphalan; Drug: Interleukin-2

• Registration Number: NCT07183852
• Lead Sponsor: Vastra Gotaland Region

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-12
• Study First Submitted QC: 2025-09-12
• Last Update Submitted: 2025-09-12
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Study Start: 2026-03-01
• Primary Completion: 2028-03
• Study Completion: 2033-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Participants must be at least 18 years of age.

2. 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.

3. World Health Organization (WHO) Performance Status 0 or 1.

4. 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

5. 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.

6. Measurable disease by computed tomography (CT) per RECIST 1.1 criteria after resection of lesion for TILs production

7. No other malignancies, except if treated with curative intent and with a cancer-related life expectancy of more than 5 years.

8. 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.

9. 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.

10. 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. 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.
2. 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.
3. Women who are pregnant or breastfeeding.
4. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	Autologous Tumor Infiltrating Lymphocytes (TIL)	Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI
Cohort 1	Melphalan	Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI
Cohort 1	Interleukin-2	Patients With Uveal Melanoma and Liver Metastases, locoregional admin using HAI
Cohort 2	Autologous Tumor Infiltrating Lymphocytes (TIL)	Patients With Cutaneous Melanoma and visceral metastases, IV admin
Cohort 2	Melphalan	Patients With Cutaneous Melanoma and visceral metastases, IV admin
Cohort 2	Interleukin-2	Patients With Cutaneous Melanoma and visceral metastases, IV admin

Primary Outcome Measures

Name	Time	Method
Incidence and severity of adverse events	5 years	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

Secondary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	2 years	RECIST 1.1
Progression free-survival (PFS)	2 years	Evaluation of Progression-free survival
hepatic Progression-free survival (hPFS)	2 years	Evaluation of hepatic Progression-free survival
Duration of objective response (DOR)	2 years	Evaluation of duration of a response by RECIST 1.1
Overall Survival (OS)	5 years	Evaluation of Overall Survival
Evaluation of feasibility of an automated production of TILs	2 years	Defined as the proportion of patients included that receive treatment with the TIL product.