Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
Phase 2
Active, not recruiting
NCT04808999
| Condition | Squamous Cell Carcinoma |
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| Phase | Phase 2 |
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| Sponsor | Diwakar Davar |
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| Status | Active, not recruiting |
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| Enrollment | 30 participants |
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| Interventions | Pembrolizumab Injection |
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| Start date | May 11, 2021 |
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| Completion date | Apr 12, 2024 |
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| Results posted | May 29, 2025 |
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Summary
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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Open in BENITIONS
View on ClinicalTrials.gov
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