NCT04147143终止不适用
Cabozantinib in Adult Patients With Advanced Renal Cell Carcinoma Following Prior Systemic Check Point Inhibition Therapy: a Retrospective, Non-interventional Study
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest2 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Incidence of serious adverse events
研究概览
简要总结
This is a non-interventional study to retrospectively evaluate the safety and to describe the effectiveness of cabozantinib after immunoncologic treatment with nivolumab or nivolumab plus ipilimumab in routine clinical practice. It consists of a retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Written informed consent and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject
- •Patients with advanced or metastatic renal cell carcinoma, including all subtypes
- •Age ≥ 18 years
- •Completion of treatment with nivolumab or nivolumab / ipilimumab combination therapy (any line of therapy) directly followed by cabozantinib treatment
排除标准
- •Patients who are unable to consent because they do not understand the nature, significance and implications of the observational trial
- •Involvement in the planning and / or conduct of the study (applies to both Ipsen staff and/or staff of sponsor and study site)
结局指标
主要结局
Incidence of serious adverse events
时间窗: through study completion, an average of 1 year
Incidence of serious adverse events at least possibly related to cabozantinib treatment during and up to 30 days after the end of cabozantinib treatment
次要结局
- Clinical benefit rate (CBR)(through study completion, an average of 1 year)
- Comparison of effectiveness endpoints of IO-cabozantinib-sequence to historical efficacy data (ORR, CBR)(through study completion, an average of 1 year)
- Time to next treatment(From date of last dose of cabozantinib until the date of first dose of next treatment, assessed up to 100 months)
- number of terminations of cabozantinib treatment due to adverse events(through study completion, an average of 1 year)
- number of dose reductions(through study completion, an average of 1 year)
- Duration of response(through study completion, an average of 1 year)
- Duration of cabozantinib treatment(through study completion, an average of 1 year)
- number of dose interruptions(through study completion, an average of 1 year)
- ORR(through study completion, an average of 1 year)
- Safety in IO-cabozantinib-sequence compared to cabozantinib single agent therapy historical data(through study completion, an average of 1 year)
研究者
研究点 (2)
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