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NCT04808999 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)
A Phase 2 study of Squamous Cell Carcinoma, sponsored by Diwakar Davar.
- Active
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT04808999: Active Phase 2 study of Squamous Cell Carcinoma, sponsored by Diwakar Davar.
NCT04808999 is a Phase 2 study of Squamous Cell Carcinoma that is active but no longer recruiting, run by Diwakar Davar. The registered enrollment target is 30 participants, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (71% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04808999, a Phase 2 study of Squamous Cell Carcinoma, is active but no longer recruiting, sponsored by Diwakar Davar.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Percentage of patients with either pathologic complete response (pCR) or partial pathologic response (pPR) per Immune-Related Pathologic Response Criteria (immunotherapy-specific pathologic response criteria (irPRC) criteria. Per (irPRC), pCR = 0% residual viable tumor (RVT) remaining in post-therapy specimen (no signs of cancer) in tissue samples removed during surgery, and pPR = \>10% but ≤50% RVT remaining in post-therapy specimen in tissue samples removed during surgery.
Conditions Studied
Interventions
- DRUG Pembrolizumab Injection
Study Locations (1)
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-05-11 |
| Est. Completion | 2029-04-30 |
| Phase | Phase 2 |
What the registry record for NCT04808999 still lists
NCT04808999 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 103-participant average among 47 other Squamous Cell Carcinoma trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Squamous Cell Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Pembrolizumab Injection is the first listed.
NCT04808999 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04808999 about?
NCT04808999 is a clinical study titled "Neoadjuvant Study of PD-1 Inhibitor Pembrolizumab in PD-1 Naive Cutaneous Squamous Cell Carcinoma (cSCC)". 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 evalu...
What is the current status of trial NCT04808999?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-05-11. Estimated completion is 2029-04-30.
What conditions does trial NCT04808999 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma.
What interventions are being tested in trial NCT04808999?
The interventions under investigation include: Pembrolizumab Injection (DRUG).
Who is sponsoring clinical trial NCT04808999?
This trial is sponsored by Diwakar Davar, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04808999 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04808999's enrollment target sits among peer trials
30 31st of 47 higher than 14 of 47 other Squamous Cell Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Squamous Cell Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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