high risk, surgically resectable, stage III Cutaneous Squamous Cell Carcinoma MedDRA version: 21.1 Level: PT Classification code 10041834 Term: Squamous cell carcinoma of skin System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: LIBTAYO
Product Name: cemiplimab
Product Code: [REGN2810]
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: FRAMMENTI MONOVALENTI E BIVALENTI DELL'ANTICORPO M
Sponsors
FONDAZIONE MELANOMA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients of either sex aged =18 years. 2) Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. 3) Patients must have histologically or cytologically locally advanced cutaneous squamous cell carcinomas. The definition of resectability can be determined by the patient's surgical oncologist and verified via discussion at Multidisciplinary Tumor Conference attended by CSCC medical and surgical oncology staff. Resectable tumors are defined as having no significant vascular, neural or bony involvement. 4) Patients must be medically fit enough to undergo surgery as determined by the surgical oncology team. 5) Patients must have measurable disease, defined by Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. 6) Eastern Cooperative Oncology Group (ECOG) performance status 0-1. 7) Patients must have organ and marrow function as defined below: absolute neutrophil count (ANC) =1.5 X 10^9/L; hemoglobin =9.5 g/dL; platelets =100 X 10^9/L; prothrombin time/international normalized ratio (PT/INR) and partial thromboplastin time (PTT) =1.5 X upper limit of normal (ULN); total bilirubin =1.5 X ULN (isolated bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1) Evidence of metastatic disease extra lymphnodal. 2) Currently and previous cancer therapy (chemotherapy, radiation therapy, immunotherapy, or biologic therapy) or investigational anti-cancer drug. 3) Prior malignancy within the prior 5 years, except for the following: in-situ cervical cancer, thyroid cancer (except anaplastic) or any cancer from which the patient has been disease-free for 2 years. 4) Any major surgery within the last 3 weeks. 5) Unwillingness or inability to follow the procedures required in the protocol. 6) Uncontrolled diabetes, hypertension, pneumonitis and abnormal thyroid function or other medical conditions that may interfere with assessment of toxicity. 7) Subjects with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of treatment. 8) Female subjects who are pregnant (positive pregnancy test), breast-feeding, or who are of childbearing potential and not practicing a reliable method of birth control. 9) Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; 10) Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Major pathological response rate (i.e., <10% remaining viable tumour cells in resected primary tumor).;Secondary Objective: •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 time from the date of first dose until the date of death from any cause.) •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; however, the following tests are planned (differences between baseline and surgical time points and at recurrence, will be compared);Primary end point(s): the major pathological response rate;Timepoint(s) of evaluation of this end point: 43-71 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Recurrence-free survival; Overall Survival; 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.;Timepoint(s) of evaluation of this end point: at disease recurrence or death from any cause; Until three years from last infusion; countinuosly during the study; screening and at recurrence of disease | — |
Countries
Italy
Contacts
Public ContactClinical Operations
Clinical Research Technology Srl
Outcome results
None listed