A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT

Condition studied

cutaneous squamous cell carcinoma

Investigational medicinal product(s)

Eligibility

Primary endpoint

To describe the proportion of patients who do not require surgery at one year in the intention-to-treat (ITT) population.

Endpoint detail

a) Event free survival (EFS). EFS is defined as time from diagnosis until progression, relapse, unplanned re-treatment after initial immunotherapy, or death as a result of any cause. b) Relapse-free survival (RFS). c) Overall survival (OS)., a) Objective response rate per iPERCIST criteria. b) Proportion of confirmed pCR via biopsy or surgery., 3a) NCI-PRO-CTCAE outcome (a selection of them, specifically built according to most frequent symptoms in cSCC patients) at baseline, at the end of upfront cemiplimab treatment, 3 months after the end of treatment in the whole patient court and evaluation of differences among responder vs non-responder patients and among locally treated vs non locally treated patients., 3b) Decision regret scale score at the end of upfront cemiplimab treatment, 1 year after the end of treatment in the whole patient court and evaluation of differences among responder vs non-responder patients and among locally treated vs non locally treated patients.