CASE (CemiplimAb-rwlc Survivorship and Epidemiology) study in advanced cutaneous squamous cell carcinoma

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. Lay abstract Cutaneous squamous cell carcinoma (CSCC) is a common form of skin cancer that is usually cured by surgery. When it progresses to a form that is incurable by surgery and/or radiotherapy, it is classified as advanced CSCC. Cemiplimab is a therapy that unleashes the immune system to fight cancer. It is the only treatment approved in the USA, Canada and Europe for the treatment of advanced CSCC. Little information exists on cemiplimab clinical experience outside of clinical trials. CASE is a Phase IV study that will collect outcomes data from patients with advanced CSCC receiving cemiplimab in a real-world setting.