SYFd6c44405c25e474c9c0df74167d77219Registry ID: 2025-523633-25-00|Not Yet RecruitingPhase 2
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interventional
N/A
1 country
10
To evaluate the ability of upfront cemiplimab to spare the need for local therapies (e.g., surgery) in patients with difficult-to-treat locally advanced cutaneous squamous cell carcinoma (LA cSCC).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 14, 2026
Actual (reported)To describe the proportion of patients who do not require surgery at one year in the intention-to-treat (ITT) population.
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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Formulated product
LIBTAYO 350 mg concentrate for solution for infusion.
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
CONCENTRATE FOR SOLUTION FOR INFUSION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
LIBTAYO 350 mg concentrate for solution for infusion.
Named ingredient: cemiplimab
View registry recordAzienda Sanitaria Universitaria Giuliano Isontina
Trieste, 34128, Italy
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131, Italy
IRCCS Azienda Ospedaliera Metropolitana
Genoa, 16132, Italy
Paolo Bossi
First Submitted
April 14, 2026
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
Contact the study team to confirm eligibility.
Istituto Oncologico Veneto
Padova, 35128, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, 00168, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Turin, 10126, Italy
Azienda Ospedaliero Universitaria Di Modena
Modena, 41124, Italy
Istituto Tumori Bari Giovanni Paolo II
Bari, 70124, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bologna, 40138, Italy
Humanitas Mirasole S.p.A.
Rozzano, 20089, Italy