NCT04822350已完成不适用
AVENANCE - A Non-interventional Study to Provide Real-world Data on the Use of Avelumab as a Maintenance Treatment for Patients With Advanced or Metastatic Urothelial Carcinoma
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
- Pfizer
- 入组人数
- 599
- 试验地点
- 81
- 主要终点
- overall survival
研究概览
简要总结
A multicenter ambispective (retrospective and prospective) non-interventional study of patients with locally advanced or metastatic urothelial carcinoma (adv/mUC) treated with avelumab in France, not impacting the treatment decision made by the treating physician and the medical management of treated patients.
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
- •Patient ≥ 18 years of age
- •Patient with locally advanced or metastatic urothelial carcinoma (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response or complete response) following completion of first-line platinum-based chemotherapy and who has been (retrospective), is (retrospective and prospective), will be (prospective) treated with avelumab.
- •For a patient alive at the moment of the inclusion in the study : the patient must be informed of the study, he/she must be given an information letter signed by the investigator and must not be opposed to the collection of his/her data
- •For a patient who died before the inclusion in the study : the patient (during his life time) must not be opposed in writing to the collection of his data.
- •Patient benefiting from a social security scheme according to local regulations
排除标准
- •For a patient alive at the moment of the inclusion in the study: patient without liberty, under tutelage, or unable to give oral consent.
- •Patient enrolled in a prospective interventional clinical trial assessing an investigational product.
研究组 & 干预措施
Locally advanced or metastatic urothelial carcinoma patients treated with avelumab
干预措施: Avelumab (Drug)
结局指标
主要结局
overall survival
时间窗: Avelumab initiation up to 4 years
time between the first injection of avelumab and the date of death from any cause
次要结局
- Overall response rate on subsequent treatments(Discontinuation of avelumab up to 4 years)
- Overall survival on subsequent treatments(Discontinuation of avelumab up to 4 years)
- overall Survival from the start of the chemotherapy used in 1st line(1st line Chemotherapy start up to 4 years)
- Progression free survival 1(Avelumab initiation up to 4 years)
- duration of treatment(Avelumab initiation up to 4 years)
- Patient reported outcome(Initiation of avelumab, 6 weeks, 3 months, and every three months for up to 2 years)
- Duration of subsequent treatments(Discontinuation of avelumab up to 4 years)
- Progression free survival 2(Avelumab initiation up to 4 years)
- duration of response(Beginning of response up to 4 years)
- Patterns of progression under avelumab(Avelumab initiation up to 4 years)
- Adverse events (AEs) reporting(Avelumab initiation up to 4 years)
- Premedications (acetaminophen and antihistamine)(Avelumab initiation up to 4 years)
- overall response rate(Avelumab initiation up to 4 years)
- Progression free survival on subsequent treatments(Discontinuation of avelumab up to 4 years)
研究者
研究点 (81)
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