This phase II trial studies how well cetuximab after immunotherapy with PD-1 inhibitors work in treating patients with head and neck squamous cell cancer. Cetuximab is an antibody (protein structure) that blocks receptors on cancer cells, called EGFR receptors, that favor the growth and multiplication of the cancer cells. Giving cetuximab may work better when given in patients who stopped responding to immunotherapy or who had to stop immunotherapy because of toxicity.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04375384.
Locations matching your search criteria
United States
North Carolina
Winston-Salem
Wake Forest University Health SciencesStatus: Active
Contact: Mercedes Porosnicu
Phone: 336-716-8664
PRIMARY OBJECTIVE:
I. To measure overall response rate to treatment with cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who failed PD-1 inhibitors alone or in combination with chemotherapy.
SECONDARY OBJECTIVES:
I. Measure duration of response (DUR), progression free survival (PFS) and overall survival (OS) for treatment with single agent cetuximab after immunotherapy with PD-1 inhibitors in head and neck squamous cell carcinoma (HNSCC).
II. 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-eight weeks and examine this data for overall tolerability of this treatment.
III. Bank optional samples of saliva and blood for future studies of biomarkers to evaluate the status of immune response after failure of treatment with immune checkpoint inhibitors and the changes induced by the treatment with cetuximab.
IV. Correlate treatment response with human papillomavirus (HPV) and smoking status.
OUTLINE:
Patients receive cetuximab intravenously (IV) over 1-2 hours every 7 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) throughout the trial, positron emission tomography (PET) scan during screening and on trial, collection of urine samples during screening and as clinically indicated throughout the trial, and undergo optional collection of blood samples at screening, on trial, and at time of progression.
After completion of study treatment, patients are followed up at 1 week and then every 4-6 weeks.
Lead OrganizationWake Forest University Health Sciences
Principal InvestigatorMercedes Porosnicu