This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.
Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
Measurable disease by scans- at least one measurable lesion.
Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.
Patients must have a Performance Status of 0-2.
Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.
Prior allergic reaction to Cetuximab.
History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.
Patients receiving any other investigational agents.
Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator