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

Inclusion Criteria

• Histologically or cytologically confirmed head and neck squamous cell carcinoma.
• Human papilloma virus (HPV) negative tumor.
• Prior treatment with a check-point inhibitor targeting PD-1, unless not a candidate.
• Prior treatment with cetuximab with tumor progression during or within 6 months after completing treatment.
• Measurable disease.
• Life expectancy ≥ 12 weeks.
• If of childbearing potential (male or female), agrees to practice an effective form of contraception during study treatment and for at least 6 months following last treatment.
• Willingness to undergo a tumor biopsy prior to starting treatment (or if biopsy is not feasible, provide archival tissue).

Exclusion Criteria

• Previous treatment with CDX-3379 or other anti-ErbB3 targeted agents.
• Nasal, paranasal sinus, or nasopharyngeal carcinoma, aside from WHO Type I and II (keratinizing, non-EBV positive) nasopharyngeal carcinoma which will be allowed.
• Major surgery within 4 weeks prior to first dose of study treatment.
• Chemotherapy within 21 days or at least 5 half-lives (whichever is shorter) prior to first dose of study treatment.
• Monoclonal based therapies within 4 weeks (excluding cetuximab) and all other immunotherapy within 2 weeks prior to first dose of study treatment.
• 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.
• Active, untreated central nervous system metastases.
• Active autoimmune disease or documented history of autoimmune disease.
• Significant cardiovascular disease including CHF or poorly controlled hypertension.