KEY TAKEAWAYS
- The C.A.S.E. study aims to evaluate the real-world effectiveness, safety, and patient experiences of those undergoing cemiplimab treatment for aBCC.
- The study is still in progress, with participant recruitment ongoing.
Current real-world data on the specifics, management, progression, and patient outcomes for advanced BCC (aBCC) is sparse. The C.A.S.E. study is actively assessing the effectiveness, safety, disease trajectory, patient survival, and patient feedback of those treated with cemiplimab outside of clinical trials. The ongoing trial aims to explore the safety and efficiency of 350 mg cemiplimab given every three weeks for aBCC pts in real-world settings.
The study will include up to 100 adult aBCC pts from around 65 U.S. sites who are on commercially available cemiplimab over a span of 24 months. Key study measures will include real-world treatment results like overall patient survival, time without disease progression, rates of response to the treatment, and the proportion of pts whose condition doesn’t worsen for at least 6 months. Additionally, response times, response durations, time to treatment failure, and specific causes of death related to the disease will be monitored.
The study will also record real-world safety data, such as adverse events related to the immune system, reactions related to the infusion, and severe adverse effects. Analysis will also be conducted on the criteria for patient selection and the patterns of treatment using descriptive statistics. Furthermore, this study aims to capture the patient’s experience with cemiplimab in real-world scenarios. To do this, measures like quality of life, functionality, and symptoms will be taken initially and during follow-up consultations, employing tools like the EORTC QLQ-C30 and Skin Care Index.
As of now, the results from this ongoing study are yet to be released, and participant recruitment is still in progress.
Source: https://eado2023.com/wp-content/uploads/2023/04/Abstract-Band_EADO2023_Stand-21-04-2023-kl.pdf
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03836105
Park, S., Ellison, D.M., Weight, R., Homsi, J., Khushalani, N., Ruiz, E., Strasswimmer, J., Simmons, J., Panella, T., Quek, R.G.W., Ursino, G., Pouliot, J-F. CemiplimAb-rwlc Survivorship and Epidemiology (C.A.S.E.): A prospective study of the safety and efficacy of cemiplimab in patients with advanced basal cell carcinoma in a real-world setting (trial in progress).
