The PD-1 inhibitor cemiplimab was approved by the EMA in June 2019, making it the first approved immunotherapy for patients with advanced cutaneous squamous cell carcinoma (CSCC) for whom curative surgery or curative radiotherapy is not an option. Previously, there was no approved systemic treatment. This study will collect data for the treatment of advanced CSCC before and after the approval of cemiplimab to better understand the changing treatment landscape and to assess treatment outcomes under real-world conditions.
Aim of the study
In our research project, we want to find out whether therapy with Libtayo® (Libtayo® is a drug for the treatment of cancer that contains the active ingredient cemiplimab, a monoclonal antibody) can slow down or prevent the progression of the disease in patients who are not eligible for surgery or radiotherapy and how the therapy affects their personal quality of life. Libtayo® (cemiplimab) works by activating your own immune system to fight cancer.
Who can take part?
Patients with advanced squamous cell carcinoma of the skin who are being treated with cemiplimab or other approaches
Procedure
If you participate, the following information will be taken from your medical file at the enrollment appointment: Age, gender, skin type, previous illnesses, history of cancer including diagnosis and previous therapies.The following data will be taken from your medical record during the study period: Current tumor status, therapy with Libtayo® (cemiplimab), and any adverse events (side effects) that may have occurred. The observation period is approx. 3 years.
Compensation
None
Original study name
Two-cohort registry study for patients with advanced CSCC treated with cemiplimab or other methods
BASEC number
2022-00155
Financial support from
Sanofi