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Cemiplimab Survivorship Epidemiology (CASE) Study
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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Oncology Specialties, PC - Clearview Cancer Institute
Huntsville, Alabama, United States
Dignity Health St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
University of California San Diego
La Jolla, California, United States
Harbor-UCLA/LA Biomedical Research Institute
Los Angeles, California, United States
St. Mary's Medical Center
San Francisco, California, United States
Regeneron Research Facility
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
The Melanoma and Skin Cancer Institute
Englewood, Colorado, United States
Regional Cancer Care Associates, LLC
Manchester, Connecticut, United States
Start Date
June 27, 2019
Primary Completion Date
September 29, 2025
Completion Date
September 29, 2025
Last Updated
October 15, 2025
287
ACTUAL participants
cemiplimab
DRUG
Lead Sponsor
Regeneron Pharmaceuticals
NCT07144384
NCT05075980
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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