Cemiplimab Survivorship Epidemiology (CASE) Study
Overview
- Phase
- Not Applicable
- Intervention
- cemiplimab
- Conditions
- Cutaneous Squamous Cell Carcinoma
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 287
- Locations
- 47
- Primary Endpoint
- Objective response rate (ORR)
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
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
Investigators
Eligibility Criteria
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
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
Arms & Interventions
Group 1
This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC.
Intervention: cemiplimab
Group 2
This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.
Intervention: cemiplimab
Outcomes
Primary Outcomes
Objective response rate (ORR)
Time Frame: Up to 36 months
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Disease control rate (DCR)
Time Frame: Up to 36 months
Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
Duration of response (DOR)
Time Frame: Up to 36 months
Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
Time to response
Time Frame: Up to 36 months
Time from date of first admission of cemiplimab to the initial response
Disease specific death (DSD)
Time Frame: Up to 36 months
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Infusion related reactions (IRRs)
Time Frame: Up to 36 months
NCI-CTCAE v5
Treatment related serious adverse reactions (SARs)
Time Frame: Up to 36 months
Progression free survival (PFS)
Time Frame: Up to 36 months
Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
Overall Survival (OS)
Time Frame: Up to 36 months
Time from the date of first administration of cemiplimab to the date of death due to any cause
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Time Frame: Up to 36 months
Pattern of recurrence
Time to treatment failure (TTTF)
Time Frame: Up to 36 months
Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
Immune related adverse events (irAEs)
Time Frame: Up to 36 months
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5