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

Primary Purpose

Malignant Melanoma

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tislelizumab
Sponsored by
Quanli Gao
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Melanoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    L-TIL and Tislelizumab

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Efficacy (ORR)
    The objective response rate (ORR) at 8 weeks from baseline.
    Efficacy (ORR)
    The objective response rate (ORR) at 16 weeks.
    Efficacy (DOR)
    The duration of response (DOR) at 1-year.
    Efficacy (DOR)
    The duration of response (DOR) at 2-year.
    Safety
    The adverse events followed by treatment.

    Secondary Outcome Measures

    Progression free survival (PFS)
    The PFS rate at 1 year.
    Progression free survival (PFS)
    The PFS rate at 2-year.
    Overall survival (OS)
    The OS rate at 1 year.
    Overall survival (OS)
    The OS rate at 2-year.

    Full Information

    First Posted
    May 31, 2021
    Last Updated
    June 15, 2021
    Sponsor
    Quanli Gao
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04924413
    Brief Title
    L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
    Official Title
    L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2022 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Quanli Gao

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Malignant Melanoma

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Model Description
    L-TIL and Tislelizumab
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    L-TIL and Tislelizumab
    Arm Type
    Experimental
    Arm Description
    L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year
    Intervention Type
    Drug
    Intervention Name(s)
    Tislelizumab
    Other Intervention Name(s)
    L-TIL
    Intervention Description
    PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion
    Primary Outcome Measure Information:
    Title
    Efficacy (ORR)
    Description
    The objective response rate (ORR) at 8 weeks from baseline.
    Time Frame
    8 weeks
    Title
    Efficacy (ORR)
    Description
    The objective response rate (ORR) at 16 weeks.
    Time Frame
    16 weeks
    Title
    Efficacy (DOR)
    Description
    The duration of response (DOR) at 1-year.
    Time Frame
    1 year
    Title
    Efficacy (DOR)
    Description
    The duration of response (DOR) at 2-year.
    Time Frame
    2 years
    Title
    Safety
    Description
    The adverse events followed by treatment.
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Progression free survival (PFS)
    Description
    The PFS rate at 1 year.
    Time Frame
    1 year
    Title
    Progression free survival (PFS)
    Description
    The PFS rate at 2-year.
    Time Frame
    2 years
    Title
    Overall survival (OS)
    Description
    The OS rate at 1 year.
    Time Frame
    1 year
    Title
    Overall survival (OS)
    Description
    The OS rate at 2-year.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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: 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quanli Gao, Ph.D
    Phone
    0371-65587483
    Email
    zlyygql0855@zzu.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiaomin Fu, Ph.D
    Phone
    0371-65587187
    Email
    52400729@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Quanli Gao, Ph.D
    Organizational Affiliation
    Henan Cancer Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    33408117
    Citation
    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.
    Results Reference
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    L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma

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