Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Public ClinicalTrials.gov record NCT03969004. 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 Randomized, Placebo-Controlled, Double-Blind Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum
Study identification
- NCT ID
- NCT03969004
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 415 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
- Jun 4, 2019 (Actual)
- Primary completion
- Jan 7, 2028 (Estimated)
- Completion
- Jan 7, 2028 (Estimated)
- Last update posted
- Mar 27, 2026
2019 – 2028
United States locations
- U.S. sites
- 40
- U.S. states
- 19
- U.S. cities
- 34
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | 85234 | — |
| Mayo Clinic Hospital | Phoenix | Arizona | 85054 | — |
| Regeneron Study Site | Tucson | Arizona | 85724-5024 | — |
| The Angeles Clinic | Los Angeles | California | 90025 | — |
| University of Southern California (USC) | Los Angeles | California | 90033 | — |
| Stanford Cancer Institute, Stanford Medicine at Stanford University | Palo Alto | California | 94304 | — |
| University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94143-0981 | — |
| George Washington University School of Medicine and Health Sciences | Washington D.C. | District of Columbia | 20037 | — |
| University of Florida Health | Gainesville | Florida | 032608 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | 33176 | — |
| University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | — |
| Regeneron Study Site | Atlanta | Georgia | 30342 | — |
| Regeneron Study Site | Chicago | Illinois | 60611 | — |
| Regeneron Study Site | Louisville | Kentucky | 40202 | — |
| Regeneron Study Site | Baltimore | Maryland | 21287 | — |
| Massachusetts General Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana Farber/Harvard Cancer Center | Boston | Massachusetts | 02215 | — |
| Michigan Medicine- University of Michigan | Ann Arbor | Michigan | 48109 | — |
| University of Missouri Health Care - University Physicians - Medicine Specialty Clinic | Columbia | Missouri | 65212 | — |
| Washington University in Saint Louis | St Louis | Missouri | 63110 | — |
| Nebraska Methodist Hospital | Omaha | Nebraska | 68114 | — |
| Memorial Sloan Kettering | Basking Ridge | New Jersey | 07920 | — |
| Memorial Sloan Kettering | Middletown | New Jersey | 07748 | — |
| Memorial Sloan Kettering | Montvale | New Jersey | 07645 | — |
| Memorial Sloan Kettering | New Brunswick | New Jersey | 08903 | — |
| Memorial Sloan Kettering | Commack | New York | 11725 | — |
| Memorial Sloan Kettering | Harrison | New York | 10604 | — |
| NYU Langone Health | New York | New York | 10016 | — |
| Columbia University | New York | New York | 10032 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Memorial Sloan Kettering | Uniondale | New York | 11553 | — |
| Regeneron Research Site | Cincinnati | Ohio | 45267 | — |
| The Ohio State University | Gahanna | Ohio | 43230 | — |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | 17025 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | 37203 | — |
| Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas | Texas | 75246 | — |
| UT Southwestern Medical Center | Dallas | Texas | 75390 | — |
| University Of Virginia Health System | Charlottesville | Virginia | 22908 | — |
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 126 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03969004, 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 Mar 27, 2026 · Synced Nov 3, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03969004 live on ClinicalTrials.gov.