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

Phase 2

Terminated

• Conditions: Malignant Melanoma
• Interventions: Drug: Tislelizumab

• Registration Number: NCT04924413
• Lead Sponsor: Quanli Gao

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-31
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-14
• Study Start: 2021-07-01
• Status Verified: 2024-07
• Primary Completion: 2024-07-02
• Study Completion: 2024-07-02
• Last Update Submitted: 2024-07-02
• Last Update Posted: 2024-07-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

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.

2. 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Efficacy (ORR)	16 weeks	The objective response rate (ORR) at 16 weeks.
Efficacy (DOR)	2 years	The duration of response (DOR) at 2-year.

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS)	2 years	The PFS rate at 2-year.
Overall survival (OS)	2 years	The OS rate at 2-year.
Safety (adverse events)	2 years	The adverse events followed by treatment.

Trial Locations

Locations (1)

Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China