Clinical Trial 20256

• Overview

  Study Title:

  CemiplimAb Survivorship Epidemiology (CASE) Study

  Summary:

  The objectives of the study are: To identify potential determinants of disease progression, Quality of life (QOL), and other health-related outcomes for patients with Cutaneous squamous cell carcinoma (CSCC) undergoing treatment with cemiplimab. To assess patient experience, including QOL and functional status, in a real-world setting for patients with CSCC. To identify and describe long-term effects of treatment of patients with CSCC. To collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants. To describe patients who receive cemiplimab as treatment for CSCC in a real-world setting. To describe real-world use patterns of cemiplimab for CSCC. To assess the long-term effectiveness of cemiplimab in CSCC patients in a real-world setting. To assess the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with Advanced and metastatic cutaneous squamous cell carcinoma (aCSCC), regardless of etiology. To assess the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with a CSCC, regardless of etiology. To assess the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC.

  Objective:

  The objectives of the study are: To identify potential determinants of disease progression, QOL, and other health-related outcomes for patients with CSCC undergoing treatment with cemiplimab To assess patient experience, including QOL and functional status, in a real-world setting for patients with CSCC To identify and describe long-term effects of treatment of patients with CSCC To collect and describe serious adverse event (SAE) and immune-related adverse event (irAE) data on study participants To describe patients who receive cemiplimab as treatment for CSCC in a real-world setting To describe real-world use patterns of cemiplimab for CSCC To assess the long-term effectiveness of cemiplimab in CSCC patients in a real-world setting To assess the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients aCSCC, regardless of etiology To assess the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with a CSCC, regardless of etiology. To assess the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC

• Treatments

  Therapies:

  Immunotherapy

  Medications:

  Cemiplimab (); REGN2810 (Cemiplimab)

• Inclusion Criteria

  > 18 years of age or older
  • Group 1: Eligible for treatment with and prescribed cemiplimab for advanced CSCC in accordance with approved prescribing information.
  • Group 2: Eligible for treatment with and prescribed cemiplimab for advanced BCC in accordance with approved prescribing information

• Exclusion Criteria

  > Receiving cemiplimab for an indication other than advanced CSCC or advanced BCC
  • Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study
  • Note: Other protocol defined Inclusion/Exclusion Criteria apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.