FOXP3 and neoplasm: Besides PFS, secondary endpoints include the evaluations of ORR, OS, and the use of tumor biopsies for the quantification of predictive biomarkers including dMMR/POLE status, HRD status, and several immune factors (CD3, CD4, CD8, CD103, PD-1, CD161, LAG3, CTLA-4, NKG2A, FOXP3, NK, and PD-L1) on myeloid and tumor cells, and describe myeloid infiltration (CD68, CD14, CD33, and CD163).