CemiplimAb Survivorship Epidemiology
Completed
Conditions studied: Cutaneous Squamous Cell Carcinoma, Basal Cell Carcinoma
In brief
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
Key facts
- Study ID
- NCT03836105
- Run by
- Regeneron Pharmaceuticals
- People needed
- 287
- Starts
- 2019-06-27
- Expected to finish
- 2025-09-29
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Integrity Clinical Research — Delray Beach, Florida, United States
- Mayo Clinic — Jacksonville, Florida, United States
- Regeneron Research Facility — Largo, Florida, United States
- Regeneron Research Facility — Miami, Florida, United States
- Miami Cancer Institute at Baptist Health, Inc. — Miami, Florida, United States
- Moffitt Cancer Center — Tampa, Florida, United States
- Lewis Hall Singletary Oncology Center at John D. Archbold Memorial Hospital — Thomasville, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- NorthShore University HealthSystem — Evanston, Illinois, United States
- Reid Oncology Association — Richmond, Indiana, United States
- CHRISTUS Highland Cancer Treatment Center — Shreveport, Louisiana, United States
- Baltimore Veterans Affairs Medical Center — Baltimore, Maryland, United States
- Frederick Health — Frederick, Maryland, United States
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
- Oncology Specialties, PC - Clearview Cancer Institute — Huntsville, Alabama, United States
Full record on ClinicalTrials.gov
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