Prospective Non-interventional Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Ipsen
- 入组人数
- 224
- 试验地点
- 156
- 主要终点
- The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
研究概览
简要总结
The purpose of the protocol, is to describe the use of cabozantinib tablets as monotherapy or in combination with nivolumab including the number of dose reductions, dose interruptions and terminations due to (serious) adverse events in subjects with advanced or metastatic renal cell carcinoma (mRCC) treated in real-life clinical setting in 1st line treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 or females aged 18 years and older with capacity to consent.
- •Subjects receiving cabozantinib as monotherapy or in combination with nivolumab as a first line treatment for advanced or metastatic renal cell carcinoma
- •Subjects with the intention to be treated with cabozantinib tablets as monotherapy or in combination with nivolumab according to the current local Summary of Product Characteristics (SmPC); decision has to be taken before entry in the study.
- •Signed written informed consent
排除标准
- •Participation in an interventional study at the same time and/or within 3 months before baseline.
- •Previous participation in this study
结局指标
主要结局
The proportion of subjects with dose interruption of cabozantinib and/or nivolumab due to SAEs/AEs
时间窗: 2 years
The proportion of subjects with ≥1 dose interruption due to AE will be described with its 95% confidence interval, by risk group and overall.
The proportion of subjects with termination of cabozantinib /cabozantinib-nivolumab combination due to SAEs/AEs
时间窗: 2 years
The proportion of subjects with ≥1 discontinuation due to AE will be described with its 95% confidence interval, by risk group and overall.
The proportion of subjects with dose reduction of cabozantinib due to Serious Adverse Events/Adverse Events (SAEs/AEs)
时间窗: 2 years
The proportion of subjects with ≥1 dose reduction due to AE will be described with its 95% confidence interval, by risk group and overall.
Number of injection delayed of nivolumab due to SAE/AE
时间窗: 2 years
次要结局
- Impact of the activity level at baseline on the occurrence of adverse events (AEs)(2 years)
- The proportion of subjects with termination due to SAEs/AEs in sub-group(2 year)
- Best overall response - Overall Response Rate (ORR)(2 years)
- The proportion of subjects with dose reduction due to SAEs/AEs in sub-group(2 years)
- Progression free survival (PFS)(2 years)
- Best overall response - Disease Control Rate (DCR)(2 years)
- All non-serious and serious adverse events (AEs / SAEs) and fatal outcomes(2 years)
- The proportion of subjects with dose interruption due to SAEs/AEs in sub-group(2 year)