A trial of 3-weekly cemiplimab in patients with locally advanced basal cell carcinoma

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-looking-at-cemiplimab-for-basal-cell-skin-cancer-impact

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.

Who can participate?
Adults over 18 years, with locally advanced basal cell carcinoma that is considered to be inappropriate for surgery or radiotherapy.

What does the study involve?
Participants will need to consent to a number of tests to check they are eligible for the study including blood tests, physical examination, an MRI or CT scan and photography of their skin cancer. Once on study, participants will need to come into hospital every 3 weeks for treatment. They will also need to come into hospital before each cycle is due to discuss side effects and have some blood tests. At certain visits photographs of their cancer will be taken along with an MRI or CT scan if required and participants will also be asked to fill out quality of life questionnaires. Once trial treatment has ended participants will enter a follow up period for 2 years. They will visit the hospital every 3 months for the first year and then every 6 months in the second year.

What are the possible benefits and risks of participating?
Benefits:
Cemiplimab treatment could potentially improve participant symptoms and quality of life. Cemiplimab has not been used in the first line treatment of locally advanced BCC previously so participants may or may not personally benefit from participation in this study. However, information from this study may help to improve treatment for patients with locally advanced BCC in the future.
Risks:
There is a potential risk to the patient that cemiplimab may not be effective or the possible side effects may outweigh the benefits. This will be minimised by regular evaluation. Patients are assessed by their treating clinician prior to every cycle of treatment and in this way any adverse events or blood results that go out of the normal range will be quickly picked up. The benefit of the treatment to the patient in the form of tumour response is monitored every 12 weeks on treatment. Regular response evaluation will ensure patients are not over-treated if cemiplimab is no longer providing any benefit. Tumour response will always involve photography but will only involve a CT/MRI scan if this is required for assessing tumour response. The use of scans for assessing tumour response will be determined after the baseline scan and will ensure that patients who will not benefit from having the extra scans are not exposed to unnecessary radiation. Safety will be overseen by the Independent Data Monitoring Committee (IDMC) who will meet regularly during the trial (at least annually).
Patients will have to attend more hospital visits over the duration of the trial both for assessment and treatment and will have more photography and potentially more CT/MRI scans all of which will be an increased burden to the patient. The patient information leaflet will make clear the visit and treatment schedule for the patient. To try and mitigate this burden we will allow patients to have 2 breaks of up to 3 weeks from treatment during the lifetime of the trial once they have completed 5 cycles of cemiplimab

Where is the study run from?
University Hospitals Bristol and Weston NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
January 2023 to April 2029

Who is funding the study?
Sanofi (France) via an ISS project grant

Who is the main contact?
impact@uhbw.nhs.uk
Dr Amarnath Challapalli, amarnath.challapalli@uhbw.nhs.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom
• Wales

Study participating centres

Sponsor information

Funders

Funder type

Industry

Results and Publications

Study outputs

Additional files

ISRCTN10511385 IMPACT protocol V2.0 12.06.23.pdf

Editorial Notes

21/12/2023: Added link to Cancer Research UK plain English summary.
31/08/2023: Uploaded protocol (not peer-reviewed) as an additional file.
03/07/2023: Internal review.
02/02/2023: Trial's existence confirmed by NHS HRA.