Clinical Trials

Inclusion Criteria:

• Ability and willingness to provide written informed consent
• Histologically or cytologically confirmed squamous cell carcinoma of the head and neck
• Locoregionally recurrent or metastatic disease that has not previously been treated with systemic therapy of recurrent or metastatic disease
• At least one measurable lesion on screening CT or MRI
• 18 years of age or older
• ECOG performance status of 0 or 1
• Acceptable bone marrow, renal, and hepatic function based upon screening lab tests
• Willingness to use medically acceptable contraception
• For females with reproductive potential: a negative serum pregnancy test

Exclusion Criteria:

• Disease which is amenable to curative local therapy
• Nasopharyngeal, salivary gland, lip or sinonasal carcinoma
• Surgery or irradiation ≤ 4 weeks prior to randomization
• Prior systemic anti-cancer therapy, unless administered for localized SCCHN and completed at least 6 months prior to disease recurrence
• Treatment with an investigational agent ≤ 30 days prior to randomization
• Treatment with corticosteroids within 2 weeks
• A requirement for chronic systemic immunosuppressive therapy for any reason
• Prior serious infusion reaction to cetuximab
• Treatment with an immunotherapy within 30 days
• Known brain metastases, unless stable for at least 28 days
• Active autoimmune disease currently requiring therapy
• Known infection with HIV
• Significant cardiac disease within 6 months
• Pregnant or breast-feeding females
• History of another primary malignancy, with the exception of (i) curatively resected non-melanoma skin cancer, (ii) curatively treated in situ cervical cancer, or (iii) other malignancy curatively treated with no evidence of disease and no anticancer therapy administered for 3 years prior to randomization, with the exception of adjuvant hormonal therapy for breast cancer
• Other conditions or circumstances that could interfere with the study