NCT05136677已完成2 期
A Phase II, Randomized, Open-label Trial of Nivolumab in Combination With Ipilimumab Versus Pemetrexed With Cisplatin or Carboplatin as First-line Therapy for Unresectable Pleural Mesothelioma in Chinese Participants
Bristol-Myers Squibb26 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年1月25日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 26
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of the combination of nivolumab and ipilimumab in Chinese participants with malignant 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
- •Histologically proven diagnosis of Malignant Pleural Mesothelioma (MPM) with determination of epithelioid vs non-epithelioid histology
- •Must have advanced unresectable disease that is not amenable to therapy with curative intent (surgery with or without chemotherapy)
- •Available tumor samples for centralized testing
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
- •Measurable disease
排除标准
- •Primitive peritoneal, pericardial, testis or tunica vaginalis mesothelioma
- •Brain metastasis, except if surgically resected or treated with stereotaxic radiotherapy
- •Prior therapy for MPM (including chemotherapy, radical pleuropneumonectomy and non-palliative radiotherapy)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A
Experimental
干预措施: Nivolumab (Biological)
Arm A
Experimental
干预措施: Ipilimumab (Biological)
Arm B
Experimental
干预措施: Pemetrexed (Drug)
Arm B
Experimental
干预措施: Cisplatin (Drug)
Arm B
Experimental
干预措施: Carboplatin (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 58 months
次要结局
- Incidence of immune-related AEs(Up to 58 months)
- Incidence of deaths(Up to 58 months)
- Incidence of participants with laboratory abnormalities(Up to 58 months)
- Objective Response Rate (ORR) by modified Response Evaluation Criteria in Solid Tumors (m-RECIST) by Investigator(Up to 58 months)
- Progression Free Survival (PFS) by m-RECIST by Investigator(Up to 58 months)
- Incidence of Adverse Events (AEs)(Up to 58 months)
- Incidence of Serious Adverse Events (SAEs)(Up to 58 months)
研究者
研究点 (26)
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