NCT03568435已完成不适用
Efficacy and Safety of Nivolumab in Metastatic Renal Cell Cancer 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 212 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
- 212
- 试验地点
- 1
- 主要终点
- Overall survival status
研究概览
简要总结
A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer
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
- •A patient with RCC with distant metastasis treated for the first time with nivolumab
排除标准
- •Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Overall survival status
时间窗: 36 months
Best overall response
时间窗: 36 months
Disease free survival
时间窗: 36 months
Progression free survival rate
时间窗: 36 months
Objective response rate
时间窗: 36 months
Duration of response
时间窗: 36 months
Incidence of adverse events
时间窗: 36 months
Incidence of serious adverse events
时间窗: 36 months
次要结局
- Distribution of socio-demographic characteristics(36 months)
- Distribution of clinical characteristics(36 months)
研究者
研究点 (1)
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_EUCTR2017-000424-10-FRICANCER173