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

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.