A phase II, single arm study investigating neoadjuvant plus adjuvant treatment with Cemiplimab in high risk, surgically resectable, stage III Cutaneaous Squamous Cell Carcinoma - NEO-CESQ

FONDAZIONE MELANOMA ONLUS0 sites25 target enrollmentOctober 22, 2020

Conditionshigh risk, surgically resectable, stage III Cutaneous Squamous Cell Carcinoma MedDRA version: 21.1Level: PTClassification code 10041834Term: Squamous cell carcinoma of skinSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

DrugsLIBTAYO

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: high risk, surgically resectable, stage III Cutaneous Squamous Cell Carcinoma
Sponsor: FONDAZIONE MELANOMA ONLUS
Enrollment: 25
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 22, 2020

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

FONDAZIONE MELANOMA ONLUS

Eligibility 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 \<35%); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \=2\.5 X ULN ^1; albumin \=2\.5 g/dL; creatinine \=1\.5 X ULN 2 OR calculated creatinine clearance \=50 mL/min OR 24\-hour urine creatinine clearance \=50 mL/min.
•8\)Female subjects of childbearing potential must have a negative pregnancy test result at baseline and must practice a reliable method of contraception for the total study duration plus 16 weeks (i.e., 30 days plus the time required for cemiplimab to undergo five half\-lives) after the last dose of cemiplimab.
•9\)Men who are sexually active with women of childbearing potential must practice a reliable method of contraception for the total study duration plus 16 weeks (i.e., 80 days plus the time required for cemiplimabto undergo five half\-lives) after the last dose of cemiplimab.
•Are the trial subjects under 18? no

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).