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CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma
Michael R Migden1, Sunandana Chandra2, Guilherme Rabinowits3
1Departments of Dermatology & Head & Neck Surgery, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, USA.
Abstract:
In 2018, cemiplimab-rwlc became the first systemic treatment approved by the US FDA for patients with metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC who are not candidates for curative surgery or curative radiation. In 2019, conditional approvals were granted by Health Canada and the European Commission for the same indications. Limited data exist pertaining to the clinical characteristics, disease progression and survivorship of patients with advanced CSCC in real-world clinical practice. CemiplimAb-rwlc Survivorship and Epidemiology (CASE) is a prospective Phase IV, noninterventional, survivorship and epidemiology study that will enroll patients with advanced CSCC who have recently initiated or who plan to receive cemiplimab in a real-world setting. Trial registration number: NCT03836105.
Insights
Cemiplimab-rwlc offers a new treatment for advanced cutaneous squamous cell carcinoma (CSCC). The CASE study will track patient outcomes in real-world settings to understand treatment effectiveness and survivorship.
Area of Science:
- Oncology
- Immunotherapy
- Epidemiology
Background:
- Cemiplimab-rwlc is the first systemic therapy approved for advanced cutaneous squamous cell carcinoma (CSCC) in the US (2018) and conditionally in Canada and Europe (2019).
- Limited real-world data exist on the clinical characteristics, disease progression, and survivorship of patients with advanced CSCC receiving systemic treatment.
- Advanced CSCC poses significant challenges, necessitating further understanding of treatment outcomes in diverse patient populations.
Purpose of the Study:
- To prospectively evaluate the real-world clinical characteristics, disease progression, and survivorship of patients with advanced CSCC initiating cemiplimab therapy.
- To gather epidemiological data on advanced CSCC in patients receiving cemiplimab in routine clinical practice.
- To assess the effectiveness and safety of cemiplimab in a broader, real-world patient cohort.
Main Methods:
- The Cemiplimab-rwlc Survivorship and Epidemiology (CASE) study is a prospective, Phase IV, noninterventional trial.
- Patients with advanced CSCC who have recently initiated or plan to receive cemiplimab will be enrolled.
- Data collection will focus on clinical characteristics, treatment patterns, disease progression, and survival outcomes.
Main Results:
- This section is to be populated with data from the study's findings once available.
- Anticipated results include detailed insights into patient demographics, treatment adherence, and response rates.
- Real-world evidence on progression-free survival and overall survival will be a key outcome.
Conclusions:
- The CASE study will provide crucial real-world evidence on the use of cemiplimab for advanced CSCC.
- Findings will enhance understanding of survivorship and epidemiological factors in this patient population.
- This research aims to inform clinical decision-making and improve patient care for advanced CSCC.
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