A reTrOspective Study on Patient's Data From the French Cemiplimab Cohort ATU Programs Compared to Standard of Care in France
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 305
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Primary Objective:
-Assess the effectiveness of cemiplimab versus other available systemic therapies in patients up to 2018 or say historical system organ class (SOC) with metastatic or locally advanced cutaneous Squamous Cell Carcinoma (CSCC) who are not candidates for curative surgery or curative radiation, on overall survival (OS).
Secondary Objectives:
- Assess Progression Free Survival (PFS)
- To assess Duration of Response (DOR)
- To assess Objective Response Rate (ORR)
- To describe adverse events leading to treatment interruptions and deaths
详细描述
Study duration is approximately 9 months. For the Standard of Care Arm, data of the subjects evaluated between 01 Aug 2013 and 01 Aug 2018 was observed. For the Cemiplimab arm, data of the subjects evaluated between Aug 2018 and October 2019 was observed.
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
- •All patients:
- •Adult 18 years of age or older
- •With an unresectable locally advanced CSCC (who are not candidates for curative surgery or curative radiation therapy) or metastatic CSCC (nodal or distant)
- •Subject alive at start data collection who has received information note and has not opposed to data collection OR
- •Subject who died before study initiation and who has not opposed to data collection for research purpose when he/she was alive
- •Treatment Group:
- •Patient treated by cemiplimab in monotherapy through the cATU or patient included in the nATU that evolved into the cATU.
- •With an Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 at the time of cemiplimab initiation
- •Control Group:
- •Patient treated by any systemic treatment initiated until August 1st , 2018 included
- •With an ECOG score of 0 or 1 at the time of treatment initiation for at least one line of systemic therapy initiated from August 1st 2013 to August 1st
- •The related treatment line must be among the 3 first systemic treatment lines for patients having initiated more than 3 lines.
排除标准
- •All patients:
- •Patient treated by another anti- Programmed Cell Death Receptor-1 (PD1)
- •Control group:
- •Patient subsequently treated with cemiplimab
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Treatment Group (Cemiplimab)
Patients treated with cemiplimab in monotherapy through the Cohort Temporary Authorization for Use (cATU) or patients included in the Nominative Temporary Authorization for Use( nATU) that evolved into the cATU and meeting the inclusion/exclusion criteria of the study.
干预措施: Cemiplimab (Drug)
Control Group
Patients treated with other systemic treatments meeting the inclusion/exclusion criteria of the study who initiated at least one systemic treatment for advanced CSCC before start date of the cemiplimab nATU
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first
The difference OS between treatment and control groups expressed as a Hazard Ratio (HR). OS is the time between treatment initiation and the date of death from any cause. For participants who are alive at data cutoff collection, their survival time will be censored at the last date that they were known to be alive.
次要结局
- Objective Response Rate (ORR)(From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first)
- Progression-Free Surivival (PFS)(From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first)
- Duration of Response (DOR)(From patient advanced CSCC diagnosis date up to last medical record available on site or the end of the observation period (July 2022),whichever occurred first)