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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cohort 1: Administered via hepatic arterial infusion Cohort 2: Administered via intravenous infusion
1 mg/kg, IV
2 MIU, subcutaneous twice daily for up to 14 days.
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
Time frame: 5 years
Objective response rate (ORR)
RECIST 1.1
Time frame: 2 years
Progression free-survival (PFS)
Evaluation of Progression-free survival
Time frame: 2 years
hepatic Progression-free survival (hPFS)
Evaluation of hepatic Progression-free survival
Time frame: 2 years
Duration of objective response (DOR)
Evaluation of duration of a response by RECIST 1.1
Time frame: 2 years
Overall Survival (OS)
Evaluation of Overall Survival
Time frame: 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.
Time frame: 2 years
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