A Multicenter, Retrospective, Observational Study of Avelumab Maintenance and Subsequent Therapies in Japanese Patients With Locally Advanced or Metastatic Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 360
- 试验地点
- 32
- 主要终点
- Characteristics of the first line PBCT just prior to avelumab maintenance
研究概览
简要总结
This study is a multicenter, non-interventional, retrospective, medical chart review of locally advanced or metastatic (la/m) Urothelial Cancer UC participants who were prescribed avelumab as first line maintenance therapy after a platinum-based chemotherapy. This study aims to understand the index date (i.e., at the initiation of avelumab maintenance therapy) demographics and clinical characteristics of participants with locally advanced/metastatic Urothelial Carcinoma in Japan, and to describe their treatment patterns and outcomes.
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
- •Participants diagnosed with locally advanced/metastatic urothelial carcinoma (la/m UC) before receiving avelumab first line maintenance therapy
- •Participants with la/m UC (irrespective of tumor histology) whose disease has not progressed (ongoing stable disease, partial response, or complete response) following completion of first line PBCT and who has been treated with avelumab
- •Participants who has been started avelumab first line maintenance therapy for la/m UC from 24 Feb 2021 (date of approval for UC) to 6 months before the date of approval of implementation of this study at each site
- •Participants aged >= 18 years old at index date
- •Other protocol defined inclusion criteria could apply
排除标准
- •Participant participated in a clinical trial in la/m UC during the study periods.
研究组 & 干预措施
Urothelial Carcinoma Cohort
This is a single cohort study enrolling Participants with Urothelial Carcinoma (UC), who are prescribed treatment with avelumab as first line maintenance therapy after a platinum-based chemotherapy (PBCT).
干预措施: Avelumab (Drug)
结局指标
主要结局
Characteristics of the first line PBCT just prior to avelumab maintenance
时间窗: Up to 3 months
Baseline clinical and demographic characteristics
时间窗: Baseline
To describe the baseline clinical and demographic characteristics of participants.
次要结局
- Objective Response Rate (ORR)(Up to 3 months)
- Progression-Free Survival (PFS)(Up to 3 months)
- Time to Treatment Failure (TTF)(Up to 3 months)
- Overall Survival (OS)(Up to 3 months)
- Time to Next Treatment (TTNT)(Up to 3 months)