The primary objective of the study is to evaluate the efficacy of neoadjuvant cemiplimab as measured by Pathologic complete response (pCR) rate per independent central pathology review. The secondary objectives of the study are: * To evaluate the efficacy of neoadjuvant cemiplimab on measures of disease response, including: * Major pathologic response (mPR) rate per independent central pathology review * pCR rate and mPR rate per local pathology review * ORR prior to surgery, according to local assessment using RECIST 1.1 * To evaluate the efficacy of neoadjuvant cemiplimab on event free survival (EFS), disease free survival (DFS), and overall survival (OS) * To evaluate the safety profile of neoadjuvant cemiplimab * To assess change in surgical plan (ablative and reconstructive procedures) from the screening period to definitive surgery, both according to investigator review and independent surgical expert review * To assess change in post-surgical management plan (radiation, chemoradiation, or observation) from the screening period to post-surgery pathology review, both according to investigator review and independent surgical expert review
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
79
Intravenous (IV) infusion every 3 weeks (Q3W)
Regeneron Study Site
Palo Alto, California, United States
Regeneron Study Site
Washington D.C., District of Columbia, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron Study Site
Tampa, Florida, United States
Regeneron Study Site
Baltimore, Maryland, United States
Regeneron Study Site
Boston, Massachusetts, United States
Regeneron Study Site
Boston, Massachusetts, United States
Regeneron Study Site
Ann Arbor, Michigan, United States
Regeneron Study Site
Omaha, Nebraska, United States
Regeneron Study Site
New York, New York, United States
...and 12 more locations
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
Time frame: Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review
Time frame: Up to 12 Weeks
Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review
Time frame: Up to 12 weeks
Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review
Time frame: Up to 12 Weeks
Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1
Time frame: Up to 12 Weeks
Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab
Time frame: Up to 12 Weeks
Number of Participants With Planned and Actual Post-Surgical Management
Time frame: Up to 14 Weeks
Event Free Survival (EFS)
Time frame: Up to 50 Months
Disease Free Survival (DFS)
Time frame: Up to 47 Months
Overall Survival (OS)
Time frame: Up to 50 Months
Incidence of Adverse Events (AEs)
Time frame: Up to 52 Months
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 52 Months
Incidence of Deaths
Time frame: Up to 52 Months
Incidence of Laboratory Abnormalities
Time frame: Up to 52 Months
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