A Phase I / II Study of Concurrent Cetuximab and Nivolumab in Patients with Recurrent and / or Metastatic Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
18 Years and older, Male and Female
This phase I / II trial studies the side effects and how well cetuximab and nivolumab work in treating patients with oral cavity, oropharyngeal, paranasal sinus, hypopharyngeal, or laryngeal cancer that have come back or spread to other places in the body. Monoclonal antibodies, such as cetuximab and nivolumab, may interfere with the ability of tumor cells to grow and spread.
I. To determine the safety and tolerability of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma (HNSCC). (Phase I)
II. To determine the 1-year overall survival rate of concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC. (Phase II)
I. To estimate response rate of patients treated with concurrent cetuximab and nivolumab who have recurrent and/or metastatic HNSCC. (Phase II)
II. To estimate progression-free survival of patients treated with concurrent cetuximab and nivolumab who have recurrent and/or metastatic HNSCC. (Phase II)
III. To evaluate the toxicity of the cetuximab and nivolumab combination in this patient population. (Phase II)
I. To identify potential biomarkers related to response to concurrent cetuximab and nivolumab in patients with recurrent and/or metastatic HNSCC.
Patients receive cetuximab intravenously (IV) and nivolumab IV on day 1 of course 1 and every 2 weeks of subsequent courses. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for 2 years.