ARON-2 Study-Multicentric International Retrospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 367
- 试验地点
- 1
- 主要终点
- Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
研究概览
简要总结
The ARON-2 study retrospectively analyze patients treated with pembrolizumab as first-line therapy in patients platinum-unfit or as second-line therapy in patients progressed after previous platinum-based chemotherapy. The amendment has been designed to also analyze patients treated with enfortumab vedotin progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor.
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
- •Patients aged >18y
- •Histologically confirmed diagnosis of UC of upper and/or lower urinary tract
- •Histologically or radiologically confirmed metastatic disease
- •Patients treated with at least one of the following:
- •Treatment with pembrolizumab in patients progressed after previous platinum-based chemotherapy or as first-line therapy in patients platinum-unfit, and at least 1 cycle of pembrolizumab within the period from 1 January 2018 to 30 November 2021
- •Treatment with enfortumab vedotin in patients progressed to previous platinum-based chemotherapy and anti-PD-1/PD-L1 inhibitor and at least 1 cycle of enfortumab vedotin within the period from June 1st 2022 to July 31st 2023
排除标准
- •Patients without histologically confirmed diagnosis of UC
- •Patients without histologically or radiologically confirmed metastatic disease
结局指标
主要结局
Overall Survival (OS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
时间窗: November 15th, 2023
Overall Response Rate (ORR) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
时间窗: November 15th, 2023
Progression-Free Survival (PFS) of patients with metastatic Urothelial Cancer (UC) treated with pembrolizumab or enfortumab vedotin
时间窗: November 15th, 2023
次要结局
- prognostic role of smoking attitude, obesity and concomitant medications in patients treated with pembrolizumab or enfortumab vedotin(November 15th, 2023)
研究者
Matteo Santoni
Oncologist
Hospital of Macerata