A Phase II/III Study to Evaluate the Safety and Efficacy of BAT1308 Combined with Platinum-Based Chemotherapy ± Bevacizumab As First-Line Therapy for PD-L1-Positive (CPS ≥ 1) Persistent, Recurrent or Metastatic Cervical Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 526
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS)
研究概览
简要总结
Phase II study: a study to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab Phase III study: a confirmatory study to evaluate the safety and efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer
详细描述
The single-arm Phase II exploratory study designed to evaluate the safety and efficacy of the study drug will include 20-50 subjects to explore the safety and preliminary efficacy of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab. Dynamic analysis will be conducted after the inclusion of 20 subject. If the safety of this combination regimen is manageable and the efficacy meets expectations, the enrollment in the Phase II study will be stopped and the Phase III study will be entered. The Phase III study is a randomized, double-blind, multicenter clinical study of BAT1308 combined with platinum-based chemotherapy ± Bevacizumab versus placebo plus platinum-based chemotherapy ± Bevacizumab as first-line therapy for PD-L1-positive (CPS ≥ 1) persistent, recurrent or metastatic cervical cancer. PFS and OS will be used as the combined endpoints, and a superiority design will be adopted with a total sample size of 476 subjects. Stratified block randomization will be performed based on the following random factors: patients will be stratified based on the presence of metastatic diseases at the time of diagnosis (Yes vs. No), PD-L1 CPS (1-10 vs. ≥ 10) and planned use of Bevacizumab (Yes vs. No).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
BAT1308 monoclonal antibody
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Paclitaxel for Injection (Drug)
BAT1308 monoclonal antibody
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: carboplatin (Drug)
BAT1308
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Recombinant humanized anti-PD-1 monoclonal antibody injection (Drug)
BAT1308
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Cisplatin (Drug)
BAT1308
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Bevacizumab Injection (Drug)
BAT1308
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: carboplatin (Drug)
BAT1308
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Paclitaxel for Injection (Drug)
BAT1308 monoclonal antibody
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Recombinant humanized anti-PD-1 monoclonal antibody injection (Drug)
BAT1308 monoclonal antibody
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Cisplatin (Drug)
BAT1308 monoclonal antibody
Strength 100 mg/4 mL, intravenous drip, recommended dose 300 mg, administered every 3 weeks (21 days) (Q3W)
干预措施: Bevacizumab Injection (Drug)
结局指标
主要结局
Progression-Free Survival (PFS)
时间窗: From first administration to the occurrence of objective tumor progression or all-cause death (whichever occurs first), the assessment period lasts up to two years.
Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
Overall Survival
时间窗: From the date of first administration to the time of death due to any cause, the assessment period will last up to two years.
Tumor assessment is performed according to RECIST 1.1. Tumor imaging assessment is performed every 9 weeks (±7 days) after the first administration until week 54. After that, it is performed once every 12 weeks (±7 days) until disease progression, withdrawal from the group, loss to follow-up, death, or 24 months after the first study drug administration at the longest distance, whichever occurs first.
次要结局
- Vital signs(Through study completion, an average of 2 years)
- Adverse event(Through study completion, an average of 2 years)
- Objective response rate (ORR)(Through study completion, an average of 2 years)
- neutralizing antibody(cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.)
- Physical examination(Through study completion, an average of 2 years)
- Laboratory Examination(Through study completion, an average of 2 years)
- anti-drug antibodies(cycle1,cycle3,cycle5 and every 9 weeks after cycle5, 21 days is a cycle and the evaluation lasts for up to 2 years.)