CemiplimAb Survivorship Epidemiology (CASE)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    500
  • sponsor
    Regeneron Pharmaceuticals
Updated on 9 May 2022
exposure to radiation
cemiplimab

Summary

The objectives of the study are:

  • To describe the effectiveness of cemiplimab 350 mg administered every 3 weeks (Q3W) for treatment of patients with advanced cutaneous squamous cell carcinoma (CSCC) and patients with advanced basal cell carcinoma (BCC) in real-world clinical settings
  • To evaluate the safety of cemiplimab based on incidence of treatment related immune-related adverse events (irAEs), infusion related reactions (IRRs), and treatment related serious adverse reactions (TSARs) in patients with advanced CSCC and patients with advanced BCC receiving cemiplimab treatment in real world clinical settings
  • To describe patient experience, including patient reported quality of life (QOL) and functional status, and clinician reported performance status in a real-world setting for patients with advanced CSCC and patients with advanced BCC
  • To describe baseline characteristics that could potentially be associated with health-related outcomes for patients with advanced CSCC and patients with advanced BCC undergoing treatment with cemiplimab
  • To describe patients who receive cemiplimab as treatment for CSCC or BCC in a real-world setting
  • To describe real-world use patterns of cemiplimab for CSCC and BCC
  • To investigate the long-term effects and effectiveness of cemiplimab in patients with advanced CSCC or advanced BCC
  • To describe the effectiveness of cemiplimab in immunosuppressed and immunocompetent patients with advanced CSCC or advanced BCC, regardless of etiology, per available data
  • To describe the effectiveness of cemiplimab after prior exposure to radiation therapy for CSCC per available data
  • To describe the effectiveness of cemiplimab as a first-line (1L) or later systemic treatment in patients with advanced CSCC, regardless of etiology, per available data
  • To describe the effectiveness of cemiplimab in patients with advanced BCC based on treatment patterns (reason for discontinuation, treatment exposure, etc) of prior HHI usage

Details
Condition Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
Treatment Cemiplimab
Clinical Study IdentifierNCT03836105
SponsorRegeneron Pharmaceuticals
Last Modified on9 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol

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
Patients concurrently participating in any study including administration of any investigational drug (including cemiplimab) or procedure (including survival follow up)
Note: Other protocol defined Inclusion/Exclusion Criteria apply
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  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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