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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Amarnath
Challapalli
+44 117 3426296
amarnath.challapalli@uhbw.nhs.uk
Dr
Emily
Foulstone
+44 117 3426738
impact@uhbw.nhs.uk
Locally advanced basal cell carcinoma (laBCC)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Background and study aims
Basal cell carcinoma (BCC) is the most common type of skin cancer worldwide. BCC tumours are generally slow growing and rarely spread to other parts of the body and outcomes for patients treated with appropriate therapy are very good. Treatment can include surgery, radiation therapy, topical treatments and photodynamic therapy.
However, in a small number of patients BCCs can get worse, progressing to an advanced stage (aBCC). These advanced tumours can become large, aggressive and penetrate through the skin into the underlying tissue. They are much more difficult to treat. Radiation can be ineffective and surgery may not be an option without causing significant morbidity, loss of function or disfigurement. The tumours also have a high risk of coming back. Newer treatments include treatment with inhibitors of the hedgehog pathway e.g. vismodegib and sonidegib. These have been shown to reduce the size of aBCC tumours in 45% of patients treated, with an average duration of 9.5 months. Although licensed for the treatment of aBCC, NICE have not approved them for use as a treatment in the UK. Therefore currently there is a lack of viable treatment options for these patients.
These tumours have a high mutation burden suggesting treatment with immunotherapy drugs would be successful. Indeed the immunotherapy drug cemiplimab has been licensed for use in this patient group as second line treatment for locally advanced or metastatic BCC after treatment with hedgehog inhibitors has failed. Again due to the fact hedgehog inhibitors are not being used in the NHS this treatment is not an option for patients in the UK. Therefore in this study we propose to evaluate the safety and efficacy of cemiplimab as first line therapy for these patients with locally advanced BCC.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Patients with metastatic BCC or Gorlins syndrome are excluded2. History of severe hypersensitivity reaction (≥grade 3) to polysorbate 80 containing drugs3. Immunosuppressive corticosteroid doses (>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab.4. Active infection requiring therapy, including positive tests for human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV).5. History of pneumonitis within the last 5 years6. Treatment with systemic immunostimulatory agents (including, but not limited to, IFNs, IL-2) within 28 days or 5 half-lives of the drug, whichever is shorter, prior to treatment start (Cycle 1 Day 1).7. Treatment with PI3K inhibitors8. Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events (irAEs).9. Any anticancer treatment within 30 days of the initial administration of cemiplimab or planned to occur during the study period other than palliative radiotherapy.10. Breastfeeding11. Positive serum pregnancy test.12. Women of childbearing potential (WOCBP), or sexually active men, who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose.13. Receipt of live vaccines (including attenuated) within 30 days of first study treatment.14. Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the patient ineligible for participation.15. History of an additional malignancy within 5 years of registration with the exception of those malignancies with a negligible risk of metastasis or death and treated with curative intent.16. Other concurrent serious illness or medical condition that in the investigator’s opinion precludes entry into the trial.17. Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.18. Prior treatment with other systemic immune-modulating agents within fewer than 28 days prior to the first dose of cemiplimab.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Emily
Foulstone
+44 117 3426738
impact@uhbw.nhs.uk
Dr
Amarnath
Challapalli
+44 117 3426296
amarnath.challapalli@uhbw.nhs.uk
The study is sponsored by University Hospitals Bristol and Weston NHS Foundation Trust and funded by Sanofi via an ISS project grant.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 54772
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