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
Study Type
OBSERVATIONAL
Enrollment
287
No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.
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
Objective response rate (ORR)
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Time frame: Up to 36 months
Disease control rate (DCR)
Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
Time frame: Up to 36 months
Duration of response (DOR)
Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
Time frame: Up to 36 months
Time to response
Time from date of first admission of cemiplimab to the initial response
Time frame: Up to 36 months
Progression free survival (PFS)
Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
Time frame: Up to 36 months
Overall Survival (OS)
Time from the date of first administration of cemiplimab to the date of death due to any cause
Time frame: Up to 36 months
Time to treatment failure (TTTF)
Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
Time frame: Up to 36 months
Disease specific death (DSD)
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Time frame: Up to 36 months
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Pattern of recurrence
Time frame: Up to 36 months
Immune related adverse events (irAEs)
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
Time frame: Up to 36 months
Infusion related reactions (IRRs)
NCI-CTCAE v5
Time frame: Up to 36 months
Treatment related serious adverse reactions (SARs)
Time frame: Up to 36 months
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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
...and 43 more locations