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

Quanli Gao

Status and phase: Terminated; Phase 2

Conditions: Malignant Melanoma

Treatments: Drug: Tislelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT04924413

HenanCH L-TIL Melanoma

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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.

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

L-TIL and Tislelizumab

Experimental group

Description:

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

Treatment:

Drug: Tislelizumab