CemiplimAb Survivorship Epidemiology
- Conditions
- Cutaneous Squamous Cell CarcinomaBasal Cell Carcinoma
- Interventions
- Registration Number
- NCT03836105
- Lead Sponsor
- Regeneron Pharmaceuticals
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 287
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 cemiplimab This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) CSCC. Group 2 cemiplimab This group will enroll patients with advanced (defined as locally advanced or metastatic \[nodal or distant\]) BCC.
- Primary Outcome Measures
Name Time Method Objective response rate (ORR) Up to 36 months The rate of complete responses (CR) or partial responses (PR), as assessed by investigators
Disease control rate (DCR) 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) 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 Up to 36 months Time from date of first admission of cemiplimab to the initial response
Disease specific death (DSD) Up to 36 months Rate of death cause by or related to underlying CSCC or BCC as assessed by investigators
Infusion related reactions (IRRs) Up to 36 months NCI-CTCAE v5
Treatment related serious adverse reactions (SARs) Up to 36 months Progression free survival (PFS) 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) 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 Up to 36 months Pattern of recurrence
Time to treatment failure (TTTF) 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) Up to 36 months Per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (47)
Oncology Specialties, PC - Clearview Cancer Institute
🇺🇸Huntsville, Alabama, United States
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
🇺🇸Nyack, New York, 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
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