Avelumab, Cetuximab, and Palbociclib in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

Open to people ages 18 years and up

• Histologically or cytologically proven squamous cell carcinoma of the head and neck not amenable to curative intent therapy.
• Presence of measurable tumor lesions per RECIST criteria v1.1
• Life expectancy greater than 12 weeks.
• Adequate hematologic, hepatic, and renal function
• Negative serum or urine pregnancy test for women of child bearing potential

• Prior therapy with an EGFR inhibitor or PD-1 or PD-L1 inhibitor in the recurrent or metastatic setting
• Uncontrolled central nervous system metastases (stable metastases permitted)
• Chemotherapy 28 days prior to first administration of study treatment and/or monoclonal antibody ≤8 weeks prior to first administration of study treatment.
• History of other malignancies,
• Concurrent systemic immunosuppressant therapy (eg, cyclosporine A, tacrolimus, etc., or chronic administration of >10 mg/day of prednisone or equivalent)
• Prior organ transplantation
• Known history of human immunodeficiency virus (HIV) or active infection with hepatitis C virus (HCV) or hepatitis B virus (HBV).