Malignant Melanoma
Conditions
Brief summary
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.
Interventions
DRUGTislelizumab
PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion
Sponsors
Quanli Gao
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
L-TIL and Tislelizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination 3. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection. 8\. Other tumor disease.
Exclusion criteria
1. Symptomatic brain metastases 2. Active infection 3. Active HBV or HCV infection 4. HIV infection 5. Autoimmune disease 6. Sensitive to drug or ingredients 7. Severe mental disorders 8. Sever disfunction of heart, liver and kidney
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy (ORR) | 8 weeks | The objective response rate (ORR) at 8 weeks from baseline. |
| Efficacy (DOR) | 1 year | The duration of response (DOR) at 1-year. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival (PFS) | 1 year | The PFS rate at 1 year. |
| Overall survival (OS) | 1 year | The OS rate at 1 year. |
| Safety (adverse events) | 2 years | The adverse events followed by treatment. |
Countries
China
Outcome results
None listed