PHASE III STUDY WITH ATEZOLIZUMAB VERSUS PLACEBO IN MALIGNANT PLEURAL MESOTHELIOMA PATIENTS AFTER PLEURECTOMY/DECORTICATION
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 162
- 试验地点
- 19
- 主要终点
- To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
研究概览
简要总结
This is a multicentric double-blind, placebo controlled, phase III trial. In this study, patients who underwent to a surgical resection of pleural mesothelioma and are without signs of macroscopic residual disease will be randomized 2:1 to receive atezolizumab or placebo. Patients will be treated for 12 months or until recurrence, unacceptable toxicity or patient/physician decision, whichever occurs first.
Randomization will be done via a centralized system and patients will be stratified histology (epithelioid vs non epithelioid) and stage (I vs
>I). Patients will be radiologically evaluated after surgical procedure before starting therapy and then every 12 weeks for 24 months or until disease progression. At screening patients should be without macroscopic residual disease. Quality of life questionnaire will be administered to patient at baseline and every 12 weeks. During the study baseline tumor blocks will be centrally analyzed to determinate biological characteristics and gene expression.
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
- Single (Care Provider)
盲法说明
This is a randomized, placebo-controlled, double-blind study. Patients will be randomized to one of the following treatment arms in a 2:1 ratio (experimental to control arm):
- Arm A (experimental arm): atezolizumab
- Arm B (control arm): placebo
Randomization will be stratified by the following factors:
- Histology (epithelioid vs non epithelioid)
- Stage (I vs >I) Blinding Investigators and patients will remain blinded to treatment assignment until the final analysis of OS, except in the event unblinding is necessary for a medical emergency or to help guide decisions on subsequent treatment.
If the investigator wishes to know the identity of the study drug for any reason other than a medical emergency, he or she should contact the Scientific Responsible. In case of unblinding, patient will be withdrawn by the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 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
Arm A
atezolizumab 1200mg every 21 days
干预措施: Atezolizumab 1200 mg in 20 ML Injection (Drug)
Arm B
Placebo will be supplied by the sponsor and will be identical in appearance to atezolizumab and will comprise the same excipients but without atezolizumab every 21 days
干预措施: Placebo (Drug)
结局指标
主要结局
To evaluate the efficacy of atezolizumab in patients with MPM in terms of DFS
时间窗: 12 weeks
DFS, defined as the time from initiation of study treatment to first recurrence of disease or death for any cause, whichever occurs first.
次要结局
- To evaluate the safety of atezolizumab in patients with MPM(12 months)
- To evaluate the efficacy of atezolizumab in patients with MPM in terms of OS(12 months)