This phase II trial studies how well the combination of cetuximab and cemiplimab works before surgery in treating patients with head and neck squamous cell cancer that can be removed by surgery (resectable). Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of tumor cells. This may help keep tumor cells from growing. Cemiplimab is a type of drug called an immune checkpoint inhibitor (a type of immunotherapy). It is a monoclonal antibody that binds to the protein PD-1 on the surface of immune cells called T cells. It works by keeping tumor cells from suppressing the immune system. This allows the immune system to attack and kill the tumor cells. Giving the combination of cetuximab and cemiplimab before surgery may make the tumor smaller.
Additional locations may be listed on ClinicalTrials.gov for NCT06855212.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Christine H. Chung
Phone: 813-745-5431
PRIMARY OBJECTIVE:
I. To evaluate the major and complete pathologic response rate of neoadjuvant cetuximab and cemiplimab combination in patients undergoing surgery for head and neck squamous cell cancer (HNSCC).
SECONDARY OBJECTIVES:
I. To evaluate the event free survival (EFS) in patients treated with the neoadjuvant cetuximab and cemiplimab combination before the surgery for HNSCC.
II. To evaluate the tolerability of the neoadjuvant cetuximab and cemiplimab combination before the surgery for HNSCC.
EXPLORATORY OBJECTIVES:
I. To identify potential biomarkers related to T-cell memory response to neoadjuvant cetuximab and cemiplimab combination in patients undergoing surgery for HNSCC.
II. To evaluate biomarkers including neutrophil lymphocyte ratio (NLR), human leukocyte antigen-I loss of heterozygosity (HLA class I LOH), TIM characterization using multiplex immunohistochemistry (mIHC) including PD-L1 expression, detection of minimal residual disease (MRD) using circulating tumor deoxyribonucleic acid (DNA), and gene expression profiling (GEP) to predict tumor response.
OUTLINE:
Patients receive cemiplimab intravenously (IV) on day 1 of each cycle and cetuximab IV on days 1, 8, and 15 of cycle 1 and on day 1 of cycle 2. Cycles repeat every 21 days for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo standard of care (SOC) surgical resection 7-21 days after cycle 2 day 1. Patients also undergo computed tomography (CT) and blood sample collection throughout the trial. Patients may undergo tissue biopsy throughout the study and may undergo magnetic resonance imaging (MRI) and/or positron emission tomography (PET)/CT as clinically indicated.
After completion of study treatment, patients are followed up at 42 days and then 16, 32, 48, and 96 weeks from SOC surgical resection.
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorChristine H. Chung
