A Phase 2, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of CDX-3379 in Combination With Cetuximab in Patients With Advanced Head and Neck Squamous Cell Carcinoma
This is a study to determine the clinical benefit (how well the drug works), safety and tolerability of combining CDX-3379 and cetuximab. The study will enroll patients with advanced head and neck squamous cell carcinoma who have previously received cetuximab and progressed.
• 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).