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
* 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
Brief Title
CemiplimAb Survivorship Epidemiology
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Cutaneous Squamous Cell Carcinoma
Basal Cell Carcinoma
Eligibility 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
* 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
Inclusion 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
Inclusion/
* Eligible for treatment with and prescribed cemiplimab for advanced CSCC or advanced BCC in accordance with approved prescribing information as described in the protocol
Inclusion/
Gender
All
Gender Based
false
Keywords
Locally Advanced CSCC (laCSCC)
Metastatic CSCC (mCSCC)
Locally Advanced BCC (laBCC)
Metastatic BCC (mBCC)
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03836105
Org Class
Industry
Org Full Name
Regeneron Pharmaceuticals
Org Study Id
R2810-ONC-1806
Overall Status
Active, not recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Cemiplimab Survivorship Epidemiology (CASE) Study
Primary Outcomes
Outcome Description
The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Outcome Measure
Objective response rate (ORR)
Outcome Time Frame
Up to 36 months
Outcome Description
Percentage of patients who have achieved CR, PR or stable disease (SD) to cemiplimab as assessed by investigators
Outcome Measure
Disease control rate (DCR)
Outcome Time Frame
Up to 36 months
Outcome Description
Time from the time of initial response until documented tumor progress, death, or initiation of non-cemiplimab CSCC or BCC treatment
Outcome Measure
Duration of response (DOR)
Outcome Time Frame
Up to 36 months
Outcome Description
Time from date of first admission of cemiplimab to the initial response
Outcome Measure
Time to response
Outcome Time Frame
Up to 36 months
Outcome Description
Time from the date of first administration of cemiplimab to progression or death from any cause, whichever occurs first
Outcome Measure
Progression free survival (PFS)
Outcome Time Frame
Up to 36 months
Outcome Description
Time from the date of first administration of cemiplimab to the date of death due to any cause
Outcome Measure
Overall Survival (OS)
Outcome Time Frame
Up to 36 months
Outcome Description
Time from date of first administration of cemiplimab to treatment discontinuation for disease progression, treatment toxicity, or death
Outcome Measure
Time to treatment failure (TTTF)
Outcome Time Frame
Up to 36 months
Outcome Description
Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Outcome Measure
Disease specific death (DSD)
Outcome Time Frame
Up to 36 months
Outcome Description
Pattern of recurrence
Outcome Measure
Number of patients with metastatic vs locally advanced cancer summarized every three weeks
Outcome Time Frame
Up to 36 months
Outcome Description
Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
Outcome Measure
Immune related adverse events (irAEs)
Outcome Time Frame
Up to 36 months
Outcome Description
NCI-CTCAE v5
Outcome Measure
Infusion related reactions (IRRs)
Outcome Time Frame
Up to 36 months
Outcome Measure
Treatment related serious adverse reactions (SARs)
Outcome Time Frame
Up to 36 months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients in this study will include men and women ≥18 years of age who have recently initiated, or who plan to initiate treatment with commercially available cemiplimab for laCSCC/mCSCC or laBCC/mBCC in a real-world setting.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Yvonne Saenger
Investigator Email
yvonne.saenger@einsteinmed.edu
Investigator Phone
646-425-5734