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

Sponsor
Quanli Gao (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04924413
Collaborator
(none)
30
Enrollment
1
Arm
54
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
L-TIL and TislelizumabL-TIL and Tislelizumab
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: L-TIL and Tislelizumab

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

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Efficacy (ORR) [8 weeks]

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

    2. Efficacy (ORR) [16 weeks]

      The objective response rate (ORR) at 16 weeks.

    3. Efficacy (DOR) [1 year]

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

    4. Efficacy (DOR) [2 years]

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

    5. Safety [2 years]

      The adverse events followed by treatment.

    Secondary Outcome Measures

    1. Progression free survival (PFS) [1 year]

      The PFS rate at 1 year.

    2. Progression free survival (PFS) [2 years]

      The PFS rate at 2-year.

    3. Overall survival (OS) [1 year]

      The OS rate at 1 year.

    4. Overall survival (OS) [2 years]

      The OS rate at 2-year.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Pathological confirmed melanoma 2. Advanced stage confirmed by radiological examination

    2. Untreated 4. ECOG PS 0-1 6. Good organ function 7. No other severe diseases such as autoimmune disease, organ transplant, chronic infection.

    3. 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Quanli Gao

    Investigators

    • Study Director: Quanli Gao, Ph.D, Henan Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Quanli Gao, Head of Immunotherapy, Henan Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT04924413
    Other Study ID Numbers:
    • HenanCH L-TIL Melanoma
    First Posted:
    Jun 14, 2021
    Last Update Posted:
    Jun 21, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Melanoma

    Study Results

    No Results Posted as of Jun 21, 2021