Future directions include an evaluation of neoadjuvant IRX-2 with anti-PD-1 and chemotherapy in stage II-III TNBC, ongoing follow-up of a randomized phase IIb trial of neoadjuvant IRX-2 regimen in HNSCC to ascertain clinical benefit, and trials evaluating efficacy of IRX-2/anti-PD-1 combination across various metastatic cancers. The gene discussed is PDCD1; the disease is metastatic malignant neoplasm.