CemiplimAb Survivorship Epidemiology (CASE)

Regeneron Pharmaceuticals

Status

Completed

Conditions

Cutaneous Squamous Cell Carcinoma

Basal Cell Carcinoma

Treatments

Drug: cemiplimab

Study type

Observational

Funder types

Industry

Identifiers

NCT03836105

R2810-ONC-1806

Details and patient eligibility

About

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

Enrollment

287 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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