As determined by flow cytometry, α-PD-1 monotherapy did not significantly affect tumor infiltration of total CD4+ (Fig. 2c) or CD8+ T cells (Fig. 2d) but, unexpectedly, it consistently and significantly skewed the balance between CD4 + CD25 + Foxp3+ Tregs and CD4 + Foxp3- Th cells (Fig. 2 e-g). This evidence concerns the gene FOXP3 and neoplasm.