NCT05493826已完成不适用
Real-world Evidence Study on the Early Use of Cemiplimab in the UK: REACT-CEMI (Real World Evidence of Advanced CSCC Treatment - With CEMIplimab)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR) within 12 months post initiation of cemiplimab
研究概览
简要总结
The primary objective is to describe the real-world clinical effectiveness of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma (laCSCC) or metastatic cutaneous squamous cell carcinoma (mCSCC) treated in routine clinical practice.
详细描述
Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020, will be followed for a minimum of 12 and a maximum of 36 months from initiation of cemiplimab.
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 >=18 years at initiation of cemiplimab.
- •Patients treated with >=1 dose of cemiplimab for laCSCC or mCSCC who were not suitable for curative surgery or curative radiation according to routine practice.
- •Patients initiating treatment with cemiplimab in the UK between 2nd July 2019 and 30th November 2020.
排除标准
- •Patients who are known to have opted out of participation in any research (as required for compliance with GDPR).
- •Patients participating in any form of investigative study (e.g., clinical trials) during the post-index observation period.
结局指标
主要结局
Overall response rate (ORR) within 12 months post initiation of cemiplimab
时间窗: 12 months
ORR, defined as the proportion of patients who have a partial or complete response to cemiplimab based on an assessment according to routine practice, as documented in medical records
次要结局
- Demographics(Baseline)
- Real-world best response within 6- and 12-months post initiation of cemiplimab(6 months, 12 months)
- Time to partial response(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- ORR within 6 months post initiation of cemiplimab(6 months)
- Time to complete response(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Disease control rate (DCR) within 6 and 12 months post initiation of cemiplimab(6 months, 12 months)
- Proportion of patients where cemiplimab treatment was interrupted, overall and by reason for interruption(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Real-world progression-free survival (rwPFS)(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Overall survival (OS)(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Proportion of patients experiencing immune-related adverse reactions (irARs) of any grade (where reported in notes)(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Duration of treatment interruption for patients experiencing irARs(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Duration of treatment (DoT)(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Time to best response(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Duration of response (DoR)(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Previous treatments(Baseline)
- Clinical characteristics outcome(Baseline)
- Number of cemiplimab infusions(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Distribution of cemiplimab dose administered at initiation(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Initial dose of anti-inflammatory drug (e.g., steroids) used to treat irARs at onset of irARs and for the duration of irARs by steroid type(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Medical history(Baseline)
- Proportion of patients permanently discontinuing treatment, overall and by reason for discontinuation(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Proportion of patients with cemiplimab treatment interruptions due to experiencing irARs(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
- Proportion of patients treated with anti-inflammatory drugs (e.g., steroids) for irARs, overall and by type of irAR(From initiation of cemiplimab until data collection or death, whichever is earliest, up to 36 months)
研究者
研究点 (1)
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