L-TIL Plus Tislelizumab as First-line Treatment in Advanced Malignant Melanoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Efficacy (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathological confirmed melanoma
- •Advanced stage confirmed by radiological examination
- •ECOG PS 0-1
- •Good organ function
- •No other severe diseases such as autoimmune disease, organ transplant, chronic infection.
- •Other tumor disease.
排除标准
- •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
研究组 & 干预措施
L-TIL and Tislelizumab
L-TIL（3-10）x10*9/m2, Q3W, 4 cycles Tislelizumab 200mg, iv, Q3W, 1 year
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Efficacy (ORR)
时间窗: 16 weeks
The objective response rate (ORR) at 16 weeks.
Efficacy (DOR)
时间窗: 2 years
The duration of response (DOR) at 2-year.
次要结局
- Progression free survival (PFS)(2 years)
- Overall survival (OS)(2 years)
- Safety (adverse events)(2 years)
研究者
Quanli Gao
Head of Immunotherapy
Henan Cancer Hospital