Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma

A Phase 2 Study of Neoadjuvant Cemiplimab for Stage II to IV (M0) Cutaneous Squamous Cell Carcinoma (CSCC)

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

Key Inclusion Criteria

• 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.
• At least 1 lesion that is measurable by RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate organ, bone marrow function, and hepatic function as defined in the protocol

Key Exclusion Criteria

• Solid malignancy within 5 years of the projected enrollment date, or hematologic malignancy (including chronic lymphocytic leukemia [CLL]) at any time
• Distant metastatic disease (M1), visceral and/or distant nodal
• Prior radiation therapy for CSCC
• Patients with a condition requiring corticosteroid therapy (>10 mg prednisone/day or equivalent) within 14 days of the first dose of study drug.
• Patients with active, known, or suspected autoimmune disease that has required systemic therapy within 5 years of the projected enrollment date.
• 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.
• Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus (HBV or HCV) infection; or diagnosis of immunodeficiency
• Active tuberculosis

NOTE: Other protocol-defined Inclusion/Exclusion Criteria apply