ABOUT THIS STUDY
- 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
- 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).
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