Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT04154943. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04154943
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 79 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 9, 2020
- Primary completion
- Nov 30, 2021
- Completion
- Nov 18, 2025
- Last update posted
- Dec 22, 2025
2020 – 2025
United States locations
- U.S. sites
- 15
- U.S. states
- 11
- U.S. cities
- 14
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Study Site | Palo Alto | California | 94304 | — |
| Regeneron Study Site | Washington D.C. | District of Columbia | 20037 | — |
| Regeneron Study Site | Miami | Florida | 33176 | — |
| Regeneron Study Site | Tampa | Florida | 33612 | — |
| Regeneron Study Site | Baltimore | Maryland | 21231 | — |
| Regeneron Study Site | Boston | Massachusetts | 02114 | — |
| Regeneron Study Site | Boston | Massachusetts | 02215 | — |
| Regeneron Study Site | Ann Arbor | Michigan | 48109 | — |
| Regeneron Study Site | Omaha | Nebraska | 68114 | — |
| Regeneron Study Site | New York | New York | 10065 | — |
| Regeneron Study Site | Charlotte | North Carolina | 28204 | — |
| Regeneron Study Site | Durham | North Carolina | 27710 | — |
| Regeneron Study Site | Cleveland | Ohio | 44195 | — |
| Regeneron Study Site | Dallas | Texas | 75390 | — |
| Regeneron Study Site | Houston | Texas | 77030 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04154943, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 22, 2025 · Synced Sep 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04154943 live on ClinicalTrials.gov.