The purpose of this study is to evaluate the feasibility, safety and tolerability of treatment with autologous tumor infiltrating lymphocytes (TIL) administered via hepatic arterial infusion in patients with liver metastases (including but not restricted to) of malignant melanoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Administered via hepatic arterial infusion
Melphalan will be administered once as an intravenous infusion.
After TIL infusion, Interleukin-2 will be administered subcutaneously once daily for up to 14 days.
Department of Oncology, Sahlgrenska University Hospital
Gothenburg, Sweden
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Adverse events are graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Time frame: 5 years from start of chemotherapy
Objective response rate (ORR)
Defined by RECIST 1.1
Time frame: 2 years from start of chemotherapy
Clinical benefit rate (CBR)
Defined by RECIST 1.1
Time frame: 18 weeks
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 response
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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