This is a multi-center, single arm, open-label, multi-agent, localized pharmacodynamic
biomarker Phase 0 trial designed to study the biological effects within the tumor
microenvironment of motolimod and motolimod combined with nivolumab when administered
intratumorally in microdose quantities via the CIVO device in patients with head and neck
squamous cell carcinoma (HNSCC). CIVO stands for comparative in vivo oncology.