This study is in progress, not accepting new patients

CemiplimAb Survivorship Epidemiology

a study on Squamous Cell Carcinoma Basal Cell Carcinoma Carcinoma

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
completion around

Description

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 (defined as locally advanced or metastatic [nodal or distant]) cutaneous squamous cell carcinoma (CSCC) and patients with advanced (defined as locally advanced or metastatic [nodal or distant]) 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 Hedgehog inhibitor (HHI) usage

Official Title

Cemiplimab Survivorship Epidemiology (CASE) Study

Keywords

Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma, Locally Advanced CSCC (laCSCC), Metastatic CSCC (mCSCC), Locally Advanced BCC (laBCC), Metastatic BCC (mBCC), Carcinoma, Cemiplimab

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • University of California San Diego
    La Jolla California 92037 United States
  • Harbor-UCLA/LA Biomedical Research Institute
    Los Angeles California 90502 United States
  • St. Mary's Medical Center
    San Francisco California 94117 United States
  • Regeneron Research Facility
    Stanford California 94063 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT03836105
Study Type
Observational
Participants
About 287 people participating
Last Updated