NCT03569436已完成不适用
Efficacy and Safety of Nivolumab in Recurrent or Metastatic Head and Neck Cancer (HNC) Patients - Japanese Real-world Data Through Clinical Chart Review
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2018年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Distribution of clinical laboratory testing
研究概览
简要总结
Non-interventional study in Japan of participants with HNC recurring or that has spread and who are treated with nivolumab
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Recurrent/metastatic HNC patients with disease progression on or after a platinum-based therapy treated with nivolumab at least once from 01-Jul-2017 through 31-Dec-2017
排除标准
- •History of participation in any clinical trials prior- or post-nivolumab treatment
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Distribution of clinical laboratory testing
时间窗: 6 months
Distribution of non-drug therapy treatment information
时间窗: 6 months
Overall survival
时间窗: 12 months
Duration of response
时间窗: 12 months
Distribution of drug therapy treatment information
时间窗: 6 months
Distribution of participant information
时间窗: 6 months
Distribution of non-medication therapy treatment history
时间窗: 12 months
Distribution of therapeutic history
时间窗: 12 months
Progression free survival
时间窗: 12 months
Objective response rate
时间窗: 12 months
次要结局
- Incidence of AE's(Up to 12 months)
- Incidence of serious AE's(Up to 12 months)
研究者
研究点 (1)
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