A Study of CDX-3379 and Cetuximab and in Patients With Advanced Head and Neck Squamous Cell Carcinoma

Exclusion Criteria

• •1. Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
• •2. Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
• •3. Major surgery within 4 weeks prior to first dose of study treatment.
• •4. Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
• •5. Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
• •6. Other prior malignancy, active within 3 years, except for localized prostate cancer, cervical carcinoma in situ, non-melanomatous carcinoma of the skin, stage 1 differentiated thyroid cancer or ductal carcinoma in situ of the breast.
• •7. Active, untreated central nervous system metastases.
• •8. Active autoimmune disease or documented history of autoimmune disease.
• •9. Significant cardiovascular disease including CHF or poorly controlled hypertension.