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NCT04924413 Clinical Trial

L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

Malignant Melanoma Clinical Trial

Official title:
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04924413
Other study ID # HenanCH L-TIL Melanoma
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 1, 2021
Est. completion date December 31, 2025

Study information
Verified date May 2021
Source Henan Cancer Hospital
Contact Quanli Gao, Ph.D
Phone 0371-65587483
Email zlyygql0855@zzu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 30
Est. completion date December 31, 2025
Est. primary completion date December 31, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tislelizumab
PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Quanli Gao

References & Publications (1)

Li T, Zhao L, Yang Y, Wang Y, Zhang Y, Guo J, Chen G, Qin P, Xu B, Ma B, Zhang F, Shang Y, Li Q, Zhang K, Yuan D, Feng C, Ma Y, Liu Z, Tian Z, Li H, Wang S, Gao Q. T Cells Expanded from PD-1(+) Peripheral Blood Lymphocytes Share More Clones with Paired Tumor-Infiltrating Lymphocytes. Cancer Res. 2021 Apr 15;81(8):2184-2194. doi: 10.1158/0008-5472.CAN-20-2300. Epub 2021 Jan 6. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Efficacy (ORR) The objective response rate (ORR) at 8 weeks from baseline. 8 weeks
Primary Efficacy (ORR) The objective response rate (ORR) at 16 weeks. 16 weeks
Primary Efficacy (DOR) The duration of response (DOR) at 1-year. 1 year
Primary Efficacy (DOR) The duration of response (DOR) at 2-year. 2 years
Primary Safety The adverse events followed by treatment. 2 years
Secondary Progression free survival (PFS) The PFS rate at 1 year. 1 year
Secondary Progression free survival (PFS) The PFS rate at 2-year. 2 years
Secondary Overall survival (OS) The OS rate at 1 year. 1 year
Secondary Overall survival (OS) The OS rate at 2-year. 2 years
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