Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Cutaneous Squamous Cell Carcinoma
In brief
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
Key facts
- Study ID
- NCT03969004
- Run by
- Regeneron Pharmaceuticals
- People needed
- 415
- Starts
- 2019-06-04
- Expected to finish
- 2028-01-07
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic Hospital — Phoenix, Arizona, United States
- Regeneron Study Site — Tucson, Arizona, United States
- The Angeles Clinic — Los Angeles, California, United States
- University of Southern California (USC) — Los Angeles, California, United States
- Stanford Cancer Institute, Stanford Medicine at Stanford University — Palo Alto, California, United States
- University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer Center — San Francisco, California, United States
- George Washington University School of Medicine and Health Sciences — Washington D.C., District of Columbia, United States
- University of Florida Health — Gainesville, Florida, United States
- Sylvester Comprehensive Cancer Center — Miami, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
- University of South Florida (USF) - H. Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
- Regeneron Study Site — Atlanta, Georgia, United States
- Regeneron Study Site — Chicago, Illinois, United States
- Regeneron Study Site — Louisville, Kentucky, United States
- Regeneron Study Site — Baltimore, Maryland, United States
- Massachusetts General Cancer Center — Boston, Massachusetts, United States
- Dana Farber/Harvard Cancer Center — Boston, Massachusetts, United States
- Michigan Medicine- University of Michigan — Ann Arbor, Michigan, United States
- University of Missouri Health Care - University Physicians - Medicine Specialty Clinic — Columbia, Missouri, United States
- Washington University in Saint Louis — St Louis, Missouri, United States
- Nebraska Methodist Hospital — Omaha, Nebraska, United States
- Memorial Sloan Kettering — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering — Middletown, New Jersey, United States
- Memorial Sloan Kettering — Montvale, New Jersey, United States
- Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
Full record on ClinicalTrials.gov
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