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

June 15, 2021 updated by: Quanli Gao
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Xiaomin Fu, Ph.D
  • Phone Number: 0371-65587187
  • Email: 52400729@qq.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: 1 year
The PFS rate at 1 year.
1 year
Progression free survival (PFS)
Time Frame: 2 years
The PFS rate at 2-year.
2 years
Overall survival (OS)
Time Frame: 1 year
The OS rate at 1 year.
1 year
Overall survival (OS)
Time Frame: 2 years
The OS rate at 2-year.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quanli Gao

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

May 31, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 21, 2021

Last Update Submitted That Met QC Criteria

June 15, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HenanCH L-TIL Melanoma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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