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NCT04154943 · ClinicalTrials.gov registry record · Phase 2
Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
A Phase 2 study, sponsored by Regeneron Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 79
- Enrollment target
NCT04154943 is a Phase 2 study that has completed, run by Regeneron Pharmaceuticals. The registered enrollment target is 79 participants.
The verdict
NCT04154943, a Phase 2 study, has completed, sponsored by Regeneron Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 79 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Cemiplimab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 79 participants |
| Start Date | 2020-03-10 |
| Est. Completion | 2025-11-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04154943
The ClinicalTrials.gov registry entry for NCT04154943 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 79 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Cemiplimab is the first listed.
NCT04154943 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04154943 about?
NCT04154943 is a clinical study titled "Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma". 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 d...
What is the current status of trial NCT04154943?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 79 participants. The study started on 2020-03-10. Estimated completion is 2025-11-19.
What interventions are being tested in trial NCT04154943?
The interventions under investigation include: Cemiplimab (DRUG).
Who is sponsoring clinical trial NCT04154943?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
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