Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

Summary

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Description

Primary Objective: • To measure Overall Response Rate to treatment with Cetuximab as single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy. Secondary Objective(s): Measure Duration of Response (DUR), Progression Free Survival and Overall S...

Primary Objective: • To measure Overall Response Rate to treatment with Cetuximab as single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy. Secondary Objective(s): Measure Duration of Response (DUR), Progression Free Survival and Overall Survival and for treatment with single agent Cetuximab after immunotherapy with PD-1 inhibitors in Head and Neck Squamous Cell Carcinoma. Evaluate treatment toxicity with single agent Cetuximab in this patient population. Exploratory Objectives: I. Evaluate the early positron emission tomography (PET) scan ability to predict tumor response. II. Collect quality of life (QOL) data on patient reported outcomes every six weeks and examine this data for overall tolerability of this treatment. III. Bank saliva and blood for future studies of biomarkers. IV. Correlate treatment response with human papillomavirus (HPV) and smoking status. OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.

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