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

Overview

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

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2021

Interventions

  • Drug: Cemiplimab
    • Intravenous (IV) infusion every 3 weeks (Q3W)

Arms, Groups and Cohorts

  • Experimental: Cemiplimab
    • Will receive IV infusion Q3W

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With Pathologic Complete Response (pCR) as Assessed by Independent Central Pathology Review
    • Time Frame: Up to 12 weeks

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Collaborator
    • Sanofi
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals

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