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 andhypopharynx

• No prior systemic therapy for treatment of R/M disease

• Patients with squamous cell carcinoma of an unknown primary are eligible providedtheir tumor tested positive for p-16 and they have previously received treatment forlocoregional 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: patientswho have received up to two courses of chemoradiotherapy (CRT) for locoregionallyadvanced disease are eligible. Induction chemotherapy will not be considered aseparate line of therapy

• At least one measurable lesion as defined by Response Evaluation Criteria In SolidTumors (RECIST) v1.1 on screening computed tomography (CT) or magnetic resonanceimaging (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]), serumglutamic-pyruvic transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x upperlimit of normal (ULN)

• Potassium >= lower limit of normal (LLN)

• Willingness to use medically acceptable contraception throughout the study periodand four months after the final administration of treatment

• For female subjects with reproductive potential: a negative serum pregnancy test atbaseline

• Ability and willingness to provide written informed consent and to comply with thestudy visits and assessment schedule

Exclusion Criteria:

• Disease amenable to curative local therapy

• Nasopharyngeal, salivary gland, lip, or sinonasal carcinoma

• Disease that requires corticosteroids or other ongoing immunosuppressive treatment

• Previous treatment with mAb-based immunotherapy for treatment of prior oncologictreatment

• 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 oruncontrolled 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 studytreatment

• Female patients who are pregnant or breast-feeding

• Any other condition or circumstance that could interfere with adherence to thestudy's procedures or requirements or otherwise compromise the study's objectives inthe opinion of the Principal Investigator