DISCERN: This study aims to comprehensively assess the molecular profile of the tumour ecosystem of cutaneous squamous cell carcinoma patients who receive immunotherapy in the neoadjuvant curative setting in order to identify molecular mechanisms facilitating treatment response and resistance and to identify molecular markers for disease monitoringComprehensive and Deep Profiling in Cutaneous Squamous Cell Carcinomas to Unravel Treatment Efficacy in Immunotherapy Treated Patients

Exclusion

1. Active solid malignancy or haematological malignancies including chronic lymphocytic leukaemia, (unless indolent or non-life-threatening) within the last 5 years. For clarity, exceptions include other non-melanoma skin cancer that has undergone potentially curative therapy, or in-situ cervical carcinoma or in-situ prostate cancer with non-detectable prostate specific antigen or any other tumour that has been treated, and the patient is deemed to be in complete remission for at least 2 years prior to enrolment.
2. Metastatic disease.
3. Steroid use >10mg prednisone per day within 14 days of study drug (except if physiologic replacement).
4. Active autoimmune disease requiring active systemic therapy within the last 5 years.
5. Interstitial lung disease or pneumonitis requiring systemic therapy in the last 5 years.
6. Active infection requiring therapy including human immunodeficiency virus (HIV)-1 or HIV-2 serum antibody, hepatitis B virus (HBV), or hepatitis C virus (HCV), or active tuberculosis.
7. Breast-feeding or positive serum pregnancy test consistent with pregnancy (excluding false positives defined as a failure of βHCG doubling in 48 hours) or inability to comply with recommended contraception.
8. Receipt of live vaccine (including attenuated) within 30 days of first study treatment.
9. Prior transplant recipient (corneal transplant patients are eligible).
10. Prior PD-L1/PD-1 inhibitor exposure for the same lesion as enrolment.
11. Squamous cell carcinoma of unknown primary (those with presumed clinical assessment of CSCC are eligible).
12. Any anticancer treatment other than radiation therapy (such as chemotherapy, targeted systemic therapy, imiquimod, photodynamic therapy), either investigational or standard of care, within 30 days of the initial administration of cemiplimab or planned to occur during the study period.
13. History of documented allergic reactions or acute hypersensitivity reaction attributed to antibody treatments.
14. Patients with allergy or hypersensitivity to cemiplimab or to any of the excipients must be excluded.
15. Institutionalised patients by order of judicial or administrative authority.
16. Not willing to comply with all study related procedures, particularly consent for collection of tumour and blood samples and imaging, at all protocol specified time points.