Cemiplimab: Intravenous (IV) infusion over 30 minutes
Placebo: Intravenous (IV) infusion over 30 minutes
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
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | |
| Mayo Clinic Hospital | Phoenix | Arizona | |
| Regeneron Study Site | Tucson | Arizona | |
| The Angeles Clinic | Los Angeles | California | |
| University of Southern California (USC) | Los Angeles | California | |
| Stanford Cancer Institute, Stanford Medicine at Stanford University | Palo Alto | California | |
| University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center | San Francisco | California | |
| George Washington University School of Medicine and Health Sciences | Washington D.C. | District of Columbia | |
| University of Florida Health | Gainesville | Florida | |
| Sylvester Comprehensive Cancer Center | Miami | Florida | |
| Miami Cancer Institute at Baptist Health, Inc. | Miami | Florida | |
| University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | |
| Regeneron Study Site | Atlanta | Georgia | |
| Regeneron Study Site | Chicago | Illinois | |
| Regeneron Study Site | Louisville | Kentucky | |
| Regeneron Study Site | Baltimore | Maryland | |
| Massachusetts General Cancer Center | Boston | Massachusetts | |
| Dana Farber/Harvard Cancer Center | Boston | Massachusetts | |
| Michigan Medicine- University of Michigan | Ann Arbor | Michigan | |
| University of Missouri Health Care - University Physicians - Medicine Specialty Clinic | Columbia | Missouri | |
| Washington University in Saint Louis | St Louis | Missouri | |
| Nebraska Methodist Hospital | Omaha | Nebraska | |
| Memorial Sloan Kettering | Basking Ridge | New Jersey | |
| Memorial Sloan Kettering | Middletown | New Jersey | |
| Memorial Sloan Kettering | Montvale | New Jersey | |
| Memorial Sloan Kettering | New Brunswick | New Jersey | |
| Memorial Sloan Kettering | Commack | New York | |
| Memorial Sloan Kettering | Harrison | New York | |
| NYU Langone Health | New York | New York | |
| Columbia University | New York | New York | |
| Memorial Sloan Kettering Cancer Center | New York | New York | |
| Memorial Sloan Kettering | Uniondale | New York | |
| Regeneron Research Site | Cincinnati | Ohio | |
| The Ohio State University | Gahanna | Ohio | |
| Penn State Hershey Children's Hospital | Hershey | Pennsylvania | |
| University of Pennsylvania | Philadelphia | Pennsylvania | |
| Sarah Cannon Research Institute - Tennessee Oncology | Nashville | Tennessee | |
| Texas Oncology - Baylor Charles A. Simmons Cancer Center | Dallas | Texas | |
| UT Southwestern Medical Center | Dallas | Texas | |
| University Of Virginia Health System | Charlottesville | Virginia |
+ 126 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03969004 on ClinicalTrials.gov ↗ ← All trials in the UK