Study of Cemiplimab in Patients With Type of Skin Cancer Stage II to IV Cutaneous Squamous Cell Carcinoma
Condition: Cutaneous Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: Cemiplimab
Intervention description: Intravenous (IV) infusion every 3 weeks (Q3W)
Intervention MeSH terms: Cemiplimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CSCC; Stage II; Stage III; Stage IV; CSCC of Head/neck; CSCC of Extremity; CSCC of Trunk

Summary:

      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
    

Eligibility criteria:

        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