Phase II Study of REGN2810 Prior to Surgery in Patients With Stage II-IV Resectable Cutaneous Squamous Cell Carcinoma of the Head and Neck
This phase II trial studies how well cemiplimab works before surgery in treating patients with stage II-IV head and neck cutaneous squamous cell cancer that has come back (recurrent) and can be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
• Biopsy-proven, primary or recurrent stage II-IV cutaneous squamous cell carcinoma of the head and neck.
• Surgical resection must be planned as primary therapy with or without adjuvant radiation therapy. Patients are eligible with previous surgical intervention if they have residual or recurrent disease, and it is greater than 4 weeks since surgery and they have fully recovered from surgery.
• Signed informed consent form (ICF).\*
• Ability and willingness to comply with the requirements of the study protocol.\*
• Age \>= 18 years.
• Absolute neutrophil count (ANC) \>= 1500 cells/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• White blood cell (WBC) counts \>= 2500/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Lymphocyte count \>= 300/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Platelet count \>= 100,000uL for patients with hematologic malignancies, platelet count \>= 75,000/uL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Hemoglobin \>= 9.0 g/dL (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Total bilirubin =\< 1.5 x upper limit of normal (ULN) with the following exception: patients with known Gilbert disease who have serum bilirubin level =\< 3 x ULN may be enrolled (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3.0 x ULN (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Alkaline phosphatase =\< 2.5 x ULN with the following exception: patients with documented bone metastases: alkaline phosphatase =\< 5 x ULN (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Serum creatinine =\< 1.5 x ULN or creatinine clearance \>= 50 mL/min on the basis of the Cockcroft-Gault glomerular filtration rate estimation (obtained within 4 weeks \[+/-3 days\] prior to study entry).
• Measurable disease per RECIST v1.1 and/or per direct clinical measurements for primary tumors upon a variance between clinical and radiographic evaluation.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT) =\< 1.5 x ULN (This applies only to patients who do not receive therapeutic anticoagulation; patients receiving therapeutic anticoagulation \[such as low-molecular-weight heparin or warfarin\] should be on a stable dose.)
• No evidence of distant metastases and measurable disease (\> 1.5 cm).
⁃ Please Note:
‣ Patients may be enrolled regardless of their language. The ICD / translator SOP will be followed for Non-English speaking patients.
‣ Cognitively-Impaired adults may be considered for this protocol. If so, the ICD / LAR SOP will be followed.