Primary outcome measures:
Pathologic complete response (pCR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]

Secondary outcome measures:

  1. Major pathologic response (mPR) rate assessed by independent central pathology review [Time Frame: Up to 12 weeks]
  2. pCR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
  3. mPR rate assessed by local pathology review [Time Frame: Up to 12 weeks]
  4. Objective response rate (ORR) prior to surgery, according to investigator assessment using RECIST 1.1 [Time Frame: Up to 12 weeks]
  5. Event free survival (EFS) [Time Frame: Up to 50 months]
  6. Disease free survival (DFS) [Time Frame: Up to 47 months]
  7. Overall survival (OS) [Time Frame: Up to 50 months]
  8. Incidence of adverse events (AEs) [Time Frame: Up to 52 months]
  9. Incidence of serious adverse events (SAEs) [Time Frame: Up to 52 months]
  10. Incidence of deaths [Time Frame: Up to 52 months]
  11. Incidence of laboratory abnormalities [Time Frame: Up to 52 months]
  12. Change in surgical plan in the screening period versus actual surgery after neoadjuvant cemiplimab [Time Frame: Up to 12 weeks]
  13. Change in post-surgical management plan in the screening period versus actual post-surgical management [Time Frame: Up to 14 weeks]

Key Inclusion Criteria:

  1. Stage II to IV (M0) CSCC, for which surgery would be recommended in routine clinical practice. For stage II patients, lesion must be ≥3 cm at the longest diameter.
  2. At least 1 lesion that is measurable by RECIST 1.1
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria:

  1. Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
  2. Distant metastatic disease (M1), visceral and/or distant nodal
  3. Prior radiation therapy for CSCC
  4. Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
  5. Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
  6. History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management.
  7. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
  8. Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply

Clinical Program: Cutaneous Oncology Program
Primary Sponsor: Regeneron Pharmaceuticals, Inc.
Contact Info: 2029941161