A Phase III, Randomized, Open Label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 605
- 试验地点
- 107
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.
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
- None
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
- •Males and Females at least 18 years of age
- •Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
- •ECOG Performance status of 0 or 1
- •Available tumor sample for testing
- •Acceptable blood work
排除标准
- •Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
- •Prior chemotherapy for pleural mesothelioma
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
- •History of other malignancy unless the subject has been disease-free for at least 3 years
- •Active, untreated central nervous system (CNS) metastasis
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab and Ipilimumab
Specified dose on specified days
干预措施: Nivolumab (Biological)
Nivolumab and Ipilimumab
Specified dose on specified days
干预措施: Ipilimumab (Biological)
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
干预措施: Pemetrexed (Drug)
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
干预措施: Cisplatin (Drug)
Pemetrexed and Cisplatin (or Carboplatin)
Specified dose on specified days
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From randomization to the date of death (Up to 40 Months)
Overall Survival was defined as the time from randomization to the date of death due to any cause. A participant who has not died was censored at last known date alive.
次要结局
- Objective Response Rate (ORR) According to PD-L1 Expression Level(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))
- Disease Control Rate (DCR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months)
- Progression Free Survival (PFS)(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
- Overall Survival (OS) According to PD-L1 Expression Level(From randomization date to the date of death (Up to 76 Months))
- Progression Free Survival (PFS) According to PD-L1 Expression Level(From randomization date to the date of first documented tumor progression or death due to any cause, whichever occurs first. (up to 76 months))
- Objective Response Rate (ORR)(From randomization date to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (Up to 76 months))
