NCT06599463已完成不适用
Efficacy Assessment of Lenvatinib Associated with Pembrolizumab in Metastatic Endometrial Cancer: a French Multicentric Retrospective Early Access Program-based Study
ARCAGY/ GINECO GROUP24 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2024年8月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 24
- 主要终点
- Median progression free survival (PFS)
研究概览
简要总结
LARENA is a multicentric retrospective study (secondary use of data) of consecutive patients prospectively registered in the lenvatinib plus pembrolizumab French early access program (Temporary Authorisation for Use). The source of data will be the patient's medical file. We will manually review all files of the participating centers.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients having received at least one dose of lenvatinib plus pembrolizumab in the context of the French early access program (Temporary Authorisation for Use) approved by the French Health Autority.
- •Patients with advanced or recurrent endometrial cancer whose disease is progressing during or following prior platinum-based chemotherapy at any stage and who are not eligible for curative surgery or radiotherapy, according to the French early access program (Temporary Authorisation for Use) approved by the French Health Autority criteria.
排除标准
- •Patients who refuse the collection and use of their personal data in the course of this research.
结局指标
主要结局
Median progression free survival (PFS)
时间窗: An estimated median follow-up of 5 months from March 2022 to May 2024.
Time from the first administration of lenvatinib + pembrolizumab to the date of the first documented disease progression according to RECIST1.1 or death due to any cause whichever occurs first.
次要结局
- Objective response rate (ORR: CR, PR)(An estimated median follow-up of 5 months from March 2022 to May 2024.)
- Overall survival (OS)(An estimated median follow-up of 5 months from March 2022 to May 2024.)
- Clinical benefit rate (CBR: SD, CR, PR).(An estimated median follow-up of 5 months from March 2022 to May 2024.)
- Safety according to NCI CTCAE criteria v5.0.(An estimated median follow-up of 5 months from March 2022 to May 2024.)
- Frequency and type of oncogeriatric testing.(an estimated median follow-up of 5 months from March 2022 to May 2024.)
- PFS with lenvatinib+pembrolizumab according to MMR/MSI status.(An estimated median follow-up of 5 months from March 2022 to May 2024.)
- Frequency and type of medical and paramedical follow-up procedures.(an estimated median follow-up of 5 months from March 2022 to May 2024.)
研究者
研究点 (24)
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