A phase II, single arm study investigating neoadjuvant plus adjuvant treatment with Cemiplimab in surgically resectable, high risk stage III/IV (M0) Cutaneaous Squamous Cell Carcinoma

Conditions

Cutaneaous Squamous Cell Carcinoma, high risk stage III/IV (M0) Cutaneaous Squamous Cell Carcinoma, surgically resectable

Brief summary

major pathological response rate (<10% remaining viable tumour cells in resected primary tumor)., Recurrence-free survival (RFS - the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause), Overall Survival (OS - the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive), Safety, To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers. Since the identification of new markers for immunotherapy is rapidly evolving, the definitive list of analyses remains to be determined

Related papers

No related papers found yet.

Interventions

DRUGCEMIPLIMAB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
major pathological response rate (<10% remaining viable tumour cells in resected primary tumor)., Recurrence-free survival (RFS - the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause), Overall Survival (OS - the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive), Safety, To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers. Since the identification of new markers for immunotherapy is rapidly evolving, the definitive list of analyses remains to be determined	—

Measure

Time frame

major pathological response rate (<10% remaining viable tumour cells in resected primary tumor)., Recurrence-free survival (RFS - the time from start of treatment until disease recurrence (local, regional or distant) or death from any cause), Overall Survival (OS - the length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive), Safety, To determine molecular and immunophenotypic changes in tumor and peripheral blood evaluating several biomarkers. Since the identification of new markers for immunotherapy is rapidly evolving, the definitive list of analyses remains to be determined

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Countries

Italy

Outcome results

None listed