©2022 Stanford Medicine
CemiplimAb Survivorship Epidemiology
Not Recruiting
Trial ID: NCT03836105
Purpose
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
Stanford Investigator(s)
Anne Lynn S. Chang, MD
Professor of Dermatology
Eligibility
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
Intervention(s):
drug: cemiplimab
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Julie Nguyen
650-723-3046