NCT07420855尚未招募不适用
International Multicentric Retrospective Study on the Use of Enfortumab Vedotin + Pembrolizumab as First-line Therapy in Patients With Locally Advanced/Metastatic Urothelial Cancer (ARON-2PLUS)
Aron Research Foundation Ets1 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2026年2月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 361
- 试验地点
- 1
- 主要终点
- overall survival in patients with la/mUC or rare GU tumors
研究概览
简要总结
The ARON-2PLUS Study is designed as an International Multicentric Retrospective Study to collect global experiences with the use of Enfortumab vedotin plus Pembrolizumab as first-line therapy in patients with locally advanced/metastatic Urothelial Cancer.
Two supplementary optional studies are designed: one is related to CT scans evaluation for 3D reconstruction analysis; the other one is an omic analysis on FFPE tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients aged >18years
- •Histologically confirmed diagnosis of la/mUC of upper and/or lower urinary tract or histologically confirmed diagnosis of rare GU tumors.
- •Histologically or radiologically confirmed metastatic disease
- •Patients treated with first-line EV+P combination
排除标准
- •Patients without histologically confirmed diagnosis of UC
- •Patients without histologically or radiologically confirmed la or mUC
结局指标
主要结局
overall survival in patients with la/mUC or rare GU tumors
时间窗: December 2030
time from the start of the therapy until death from any cause
progression-free survival
时间窗: December 2030
time from the start of the therapy until progression or death from any cause.
次要结局
- Evaluation of adverse event(December 2030)
- Objective Response Rate (ORR) Based on RECIST v1.1(December 2030)
研究者
研究点 (1)
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