NCT04353765已完成不适用
Non - Interventional, Retrospective Study Of Cabozantinib Treatment In Patients With Unresectable, Locally Advanced Or Metastatic Renal Cell Carcinoma Who Progressed After Previous Treatment With Checkpoint Inhibitors
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ipsen
- 入组人数
- 247
- 试验地点
- 1
- 主要终点
- 6 months Real-World Response Rate
研究概览
简要总结
To understand the epidemiology, treatment patterns and outcomes of patients with metastatic Renal Cell Carcinoma (mRCC). Data from mRCC patients who received cabozantinib versus non-cabozantinib Tyrosine Kinase Inhibitor (TKI) (a type of targeted cancer drug) immediately after Check Point Inhibitor (CPI) treatment (a type of immunotherapy that blocks proteins that stop the immune system from attacking the cancer cells) in US community oncology practices will be analyzed.
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
- •Evidence of metastatic Renal Cell Carcinoma (mRCC) during the study period (May 01, 2016 to March 31, 2020);
- •Patients who received cabozantinib or non-cabozantinib TKI regimens during identification period (May 01, 2016 to September 30, 2019);
- •Patients who received CPIs, as monotherapy, or in combination with a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor (e.g. ipilimumab+nivolumab), as the latest treatment for mRCC administrated before cabozantinib or other TKI therapy;
- •Patients ≥ 18 years of age as of their index date
- •Patients who received care at a US Oncology Network site
- •Patients with ≥ 2 visits within the US Oncology Network.
排除标准
- •Patients enrolled in a clinical trial at any time during index period
- •Patients receiving treatment for another documented primary cancer diagnoses during the study period
研究组 & 干预措施
cabozantinib arm
干预措施: Cabozantinib monotherapy (Drug)
non cabozantinib Tyrosine Kinase Inhibitors (TKI) arm
干预措施: All authorized TKI monotherapies in advanced RCC per FDA label in advanced RCC (Drug)
结局指标
主要结局
6 months Real-World Response Rate
时间窗: From start of index treatment until 6 months of follow up or end of the treatment or death whichever occurs first
次要结局
- Real-World Duration of Response(From date of index treatment response and the earliest date of progressive disease)
- Real-World Overall Response Rate(From start of index treatment until end of the treatment or death whichever occurs first)
- Overall Survival(From start of index treatment until death or end of the study whichever occurs first)
- Time to treatment discontinuation(From start of index treatment until treatment discontinuation)
- Treatment dose reductions(From start of index treatment until treatment discontinuation)
- Drug discontinuation due to its toxicity(From start of index treatment until treatment discontinuation (through study completion))
- Real-World Progression Free Survival(From start of index treatment until the earliest of death, end of study database, or evidence of Progressive Disease)
- Treatment duration(From start of index treatment until treatment discontinuation)
- Rate of hospitalisations(From start of index treatment until treatment discontinuation)
研究者
研究点 (1)
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