A multi-center, non-randomized, open label, phase I/II study was conducted at Moffitt Cancer Center, Ohio State University and Emory University. Early results of the clinical trial in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) has been previously published, showing that the combination of cetuximab and nivolumab has manageable toxicities and is more efficacious compared to the response rate of historical cetuximab or anti-<a href="https://www.ncbi.nlm.nih.gov/gene/5133">PD-1</a> monotherapy (<a href="https://www.ncbi.nlm.nih.gov/pubmed/33803335">Chung et al., Cancers 2021</a>, <a href="https://www.ncbi.nlm.nih.gov/pubmed/35344035">Chung et al., Clin Cancer Res 2022</a>). Additional exploratory correlative studies were also conducted using the clinical specimens including formalin fixed paraffin embedded (FFPE) tumors and serially collected plasma cell free DNA (cfDNA; pre-treatment, on-treatment, and time of disease progression/end of treatment). These biomarker results were correlated with the clinical data obtained from the trial patients. Evaluated molecular biomarkers include DNA and RNA-sequencing and multiple immunohistochemistry markers. Altogether, our findings indicate that <a href="https://www.ncbi.nlm.nih.gov/gene/1029">p16</a>-negative R/M HNSCC patients may have greater benefit from the combination of cetuximab and nivolumab compared to patients with p16-positive HNSCC. It is anticipated that this resource will facilitate researchers to advance the therapeutic development by further understanding of HNSCC biology and provide tools to improve the clinical outcomes in incurable R/M HNSCC.

Cetuximab and Nivolumab in Recurrent/Metastatic Head and Neck Cancer

Phase II multi-institutional clinical trial result of concurrent cetuximab and nivolumab in recurrent and/or metastatic head and neck squamous cell carcinoma.

Concurrent Cetuximab and Nivolumab as a Second-Line or beyond Treatment of Patients with Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: Results of Phase I/II Study