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Clinical Trials in the UK / NCT03969004
Active, not recruiting Phase 3

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

NCT03969004 · tracked via the Priya Life Science UK tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2019-06-04
Last updated
2026-03-27

Condition(s) studied

Cutaneous Squamous Cell Carcinoma

Investigational drug(s) / intervention(s)

CemiplimabPlacebo

Cemiplimab: Intravenous (IV) infusion over 30 minutes

Placebo: Intravenous (IV) infusion over 30 minutes

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: * For Japan only, men and women ≥21 years old * Patient with resection of pathologically confirmed CSCC (primary CSCC lesion only, or primary CSCC with nodal involvement, or CSCC nodal metastasis with known primary CSCC lesion previously treated within the draining lymph node echelon), with macroscopic gross resection of all disease * High risk CSCC, as defined in the protocol * Completion of curative intent post-operative radiation therapy (RT) within 2 to 10 weeks of randomization * Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1 * Adequate hepatic, renal, and bone marrow function as defined in the protocol Key Exclusion Criteria: * Squamous cell carcinomas (SCCs) arising in non-cutaneous sites as defined in the protocol * Concurrent malignancy other than localized CSCC and/or history of malignancy other than localized CSCC within 3 years of date of randomization as defined in the protocol * Patients with hematologic malignancies (note: patients with chronic lymphocytic leukemia (CLL) are not excluded if they have not required systemic therapy for CLL within 6 months of enrollment) * Patients with history of distantly metastatic CSCC (visceral or distant nodal), unless the disease-free interval is at least 3 years (regional nodal involvement of disease in draining lymph node basin that was resected and radiated prior to enrollment will not be exclusionary) * Ongoing or recent (within 5 years of randomization date) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs). The following are not exclusionary: vitiligo, childhood asthma that has resolved, type 1 diabetes, residual hypothyroidism that required only hormone replacement, or psoriasis that does not require systemic treatment. * Has had prior systemic anti-cancer immunotherapy for CSCC Note: Other protocol defined Inclusion/Exclusion criteria apply

Primary outcome measure(s)

Trial sites (166)

FacilityCityRegionStatus
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.

On this site

📄 Libtayo (cemiplimab) drug profile →

More Regeneron Pharmaceuticals trials in the UK

Official registry record

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