Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
2期
进行中（已停止招募）
NCT04808999
| 适应症 | Squamous Cell Carcinoma |
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| 分期 | 2期 |
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| 申办方 | Diwakar Davar |
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| 状态 | 进行中（已停止招募） |
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| 受试者人数 | 30 人 |
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| 干预（药物） | Pembrolizumab Injection |
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| 开始日期 | 2021年5月11日 |
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| 完成日期 | 2024年4月12日 |
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| 结果公布日 | 2025年5月29日 |
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摘要
This phase II single-arm two-stage neoadjuvant study of pembrolizumab in patients with PD-1 naïve high-risk resectable cutaneous squamous cell carcinoma (cSCC) will be conducted over a 52-week period. The study will include patients who have not undergone surgery to remove disease, to formally evaluate whether both biologically and clinically high-risk disease may benefit from neoadjuvant anti-PD-1 therapy. Response to neoadjuvant anti-PD-1 therapy will be evaluated for association with improved landmark Relapse-free Survival (RFS).
Pathologic Response
At time of surgery, up to 6 weeks post-baseline · percentage of patients
| Pembrolizumab | 63.0 percentage of patients |
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| Pembrolizumab | 7.4 percentage of patients |
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Response Assessment Per Immune-Related Pathologic Response Criteria (irPRC)
At time of surgery · Participants
| Pembrolizumab | 17 Participants |
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| Pembrolizumab | 2 Participants |
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| Pembrolizumab | 8 Participants |
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本页整理自 ClinicalTrials.gov 的公开数据，不构成医疗建议，也不构成投资建议。请务必咨询专业医师。