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

NCT04924413 | Terminated Phase 2

• 1 other identifier: HenanCH L-TIL Melanoma
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Melanoma

Outcome Measures

Primary Outcomes (4)

• Efficacy (ORR)

  The objective response rate (ORR) at 8 weeks from baseline.

  8 weeks

• Efficacy (ORR)

  The objective response rate (ORR) at 16 weeks.

  16 weeks

• Efficacy (DOR)

  The duration of response (DOR) at 1-year.

  1 year

• Efficacy (DOR)

  The duration of response (DOR) at 2-year.

  2 years

Secondary Outcomes (5)

• Progression free survival (PFS)

  1 year

• Progression free survival (PFS)

  2 years

• Overall survival (OS)

  1 year

• Overall survival (OS)

  2 years

• Safety (adverse events)

  2 years

Study Arms (1)

L-TIL and Tislelizumab

EXPERIMENTAL

L-TIL（3-10）x10\*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year

Drug: Tislelizumab

Interventions

Tislelizumab DRUG

PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion

Also known as: L-TIL

L-TIL and Tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.
• \. Other tumor disease.

You may not qualify if:

• Symptomatic brain metastases
• Active infection
• Active HBV or HCV infection
• HIV infection
• Autoimmune disease
• Sensitive to drug or ingredients
• Severe mental disorders
• Sever disfunction of heart, liver and kidney

Sponsors & Collaborators

• Quanli Gao: lead

Study Sites (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Related 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.

  PMID: 33408117 BACKGROUND

MeSH Terms

Conditions

Melanoma

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Quanli Gao, Ph.D

  Henan Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Immunotherapy

Model Details: L-TIL and Tislelizumab

Study Record Dates

• First Submitted: May 31, 2021
• First Posted: June 14, 2021
• Study Start: July 1, 2021
• Primary Completion: July 2, 2024
• Study Completion: July 2, 2024
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)