NCT04154943已完成2 期
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review.
The secondary objectives of the study are:
- To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including:
- Major pathologic response (mPR) rate per independent central pathology review
- pCR rate and mPR rate per local pathology review
- ORR prior to surgery, according to local assessment using RECIST 1.1
- To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS)
- To evaluate the safety profile of neoadjuvant cemiplimab
- To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review
- To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Cemiplimab
Experimental
Will receive IV infusion Q3W
干预措施: Cemiplimab (Drug)
结局指标
主要结局
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
时间窗: Up to 12 weeks
次要结局
- Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review(Up to 12 Weeks)
- Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review(Up to 12 weeks)
- Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review(Up to 12 Weeks)
- Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1(Up to 12 Weeks)
- Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab(Up to 12 Weeks)
- Number of Participants With Planned and Actual Post-Surgical Management(Up to 14 Weeks)
- Event Free Survival (EFS)(Up to 50 Months)
- Disease Free Survival (DFS)(Up to 47 Months)
- Overall Survival (OS)(Up to 50 Months)
- Incidence of Adverse Events (AEs)(Up to 52 Months)
- Incidence of Serious Adverse Events (SAEs)(Up to 52 Months)
- Incidence of Laboratory Abnormalities(Up to 52 Months)
- Incidence of Deaths(Up to 52 Months)
研究者
研究点 (1)
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