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Clinical Trial 20256

Cancer Type: Cutaneous
Study Type: Treatment
NCT#: NCT03836105

Phase: Phase IV
Prinicipal Investigator:

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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

Medications

Cemiplimab (); REGN2810 (Cemiplimab)

Inclusion Criteria

> Receiving treatment with cemiplimab for CSCC, or initiating treatment with cemiplimab for CSCC

Exclusion Criteria

> Receiving cemiplimab for an indication other than CSCC

  • 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

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