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

Conditions

cutaneous squamous cell carcinoma

Brief summary

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

Detailed description

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.

Related papers

No related papers found yet.

Interventions

DRUGLIBTAYO 350 mg concentrate for solution for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Outcome results

None listed