The main purpose of this study is to evaluate the safety and effectiveness of liquid tumor infiltrating lymphocytes (L-TIL) combined with tislelizumab as the first-line treatment in patients with advanced malignant melanoma. This study plan to include stage III or IV unresectable or metastatic cutaneous or acral malignant melanoma patients, treat with L-TIL 4 cycles with each infusion (3 -10) x10\*9/m2 cells, combined with tislelizumab 200mg, iv, Q3W. It is expected that 30 patients will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion
Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
Zhengzhou, Henan, China
Efficacy (ORR)
The objective response rate (ORR) at 8 weeks from baseline.
Time frame: 8 weeks
Efficacy (ORR)
The objective response rate (ORR) at 16 weeks.
Time frame: 16 weeks
Efficacy (DOR)
The duration of response (DOR) at 1-year.
Time frame: 1 year
Efficacy (DOR)
The duration of response (DOR) at 2-year.
Time frame: 2 years
Progression free survival (PFS)
The PFS rate at 1 year.
Time frame: 1 year
Progression free survival (PFS)
The PFS rate at 2-year.
Time frame: 2 years
Overall survival (OS)
The OS rate at 1 year.
Time frame: 1 year
Overall survival (OS)
The OS rate at 2-year.
Time frame: 2 years
Safety (adverse events)
The adverse events followed by treatment.
Time frame: 2 years
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