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

Study Overview
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Brief Summary
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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

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

Conditions
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Cutaneous Squamous Cell Carcinoma

Intervention / Treatment
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* Drug: Cemiplimab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cemiplimab<br>Will receive IV infusion Q3W | Drug: Cemiplimab<br>* Intravenous (IV) infusion every 3 weeks (Q3W)<br>* Other names: Libtayo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review |  | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Major Pathologic Response (mPR) as Assessed by Independent Central Pathology Review |  | Up to 12 Weeks | 
| Number of Participants With Pathologic Complete Response (pCR) as Assessed by Local Pathology Review |  | Up to 12 weeks | 
| Number of Participants With Major Pathologic Response (mPR) as Assessed by Local Pathology Review |  | Up to 12 Weeks | 
| Percentage of Participants With Objective Response Rate (ORR) Prior to Surgery, According to Investigator Assessment Using RECIST 1.1 |  | Up to 12 Weeks | 
| Number of Participants With Planned and Actual Surgery After Neoadjuvant Cemiplimab |  | Up to 12 Weeks | 
| Number of Participants With Planned and Actual Post-Surgical Management |  | Up to 14 Weeks | 
| Event Free Survival (EFS) |  | Up to 50 Months | 
| Disease Free Survival (DFS) |  | Up to 47 Months | 
| Overall Survival (OS) |  | Up to 50 Months | 
| Incidence of Adverse Events (AEs) |  | Up to 52 Months | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 52 Months | 
| Incidence of Deaths |  | Up to 52 Months | 
| Incidence of Laboratory Abnormalities |  | Up to 52 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CSCC, Stage II, Stage III, Stage IV, CSCC of Head/neck, CSCC of Extremity, CSCC of Trunk