Cemiplimab, Low-Dose Paclitaxel and Carboplatin for the Treatment of Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

Inclusion Criteria

• Recurrent/metastatic (R/M) SCCHN of the oral cavity, oropharynx, larynx and hypopharynx
• No prior systemic therapy for treatment of R/M disease
• Patients with squamous cell carcinoma of an unknown primary are eligible provided their tumor tested positive for p-16 and they have previously received treatment for locoregional head and neck cancer
• Must be at least four weeks since prior radiation and/or surgery
• Must be at least four weeks from curative intent systemic therapy. Of note: patients who have received up to two courses of chemoradiotherapy (CRT) for locoregionally advanced disease are eligible. Induction chemotherapy will not be considered a separate line of therapy
• At least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonance imaging (MRI)
• 18 years of age and older
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• White blood cell (WBC) count > 2,500 cells/uL
• Absolute neutrophil count (ANC) > 1,500 cells/uL
• Platelet count >= 100,000 cells/uL
• Hemoglobin >= 9 g/dL
• Creatinine =< 1.6 mg/dL
• Total bilirubin =< 1.6 mg/dL
• Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]), serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upper limit of normal (ULN)
• Potassium >= lower limit of normal (LLN)
• Willingness to use medically acceptable contraception throughout the study period and four months after the final administration of treatment
• For female subjects with reproductive potential: a negative serum pregnancy test at baseline
• Ability and willingness to provide written informed consent and to comply with the study visits and assessment schedule

Exclusion Criteria

• Disease which is amenable to curative local therapy
• Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma
• Disease that requires corticosteroids (> 10 mg prednisone or equivalent daily within four weeks prior to the first dose of cemiplimab) or other immune suppressives at baseline
• Previous treatment with mAb-based immune therapies for treatment of prior oncologic treatment
• Previous treatment with PI3K inhibitors
• Known brain metastases, unless stable for at least 21 days prior to registration
• Known infection human immunodeficiency virus (HIV), hepatitis B or C
• Clinically significant cardiac disease (e.g., congestive heart failure, unstable or uncontrolled angina, myocardial infarction) within the past six months
• History of pneumonitis within the past five years
• Recipient of live vaccines (including attenuated) within 30 days of planned study treatment
• Female patients who are pregnant or breast-feeding
• Any other condition or circumstance that could interfere with adherence to the study’s procedures or requirements or otherwise compromise the study’s objectives in the opinion of the Principal Investigator