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Study identifier: NCT03969004 Synced from ClinicalTrials.gov · August 07, 2026
● Study status: Active Not Recruiting

Study of Adjuvant Cemiplimab Versus Placebo After Surgery and Radiation Therapy in Patients With High Risk Cutaneous Squamous Cell Carcinoma

Condition: Cutaneous Squamous Cell Carcinoma  ·  Sponsor: Regeneron Pharmaceuticals

PhasePhase 3
Planned participants415
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

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Locations (166)

Banner MD Anderson Cancer CenterGilbert, Arizona, United States
Mayo Clinic HospitalPhoenix, Arizona, United States
Regeneron Study SiteTucson, Arizona, United States
The Angeles ClinicLos Angeles, California, United States
University of Southern California (USC)Los Angeles, California, United States
Stanford Cancer Institute, Stanford Medicine at Stanford UniversityPalo Alto, California, United States
University Of California San Francisco (UCSF) - Helen Diller Family Comprehensive Cancer CenterSan Francisco, California, United States
George Washington University School of Medicine and Health SciencesWashington D.C., District of Columbia, United States
University of Florida HealthGainesville, Florida, United States
Sylvester Comprehensive Cancer CenterMiami, 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 InstituteTampa, Florida, United States

+ 154 more locations — full list on the registry record.

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