FOXP3 and neoplasm: In an analysis of the associations between additional pretreatment markers of tumor infiltration/inflammation and efficacy of BEMPEG + NIVO versus NIVO monotherapy, higher levels of CD8+ TILs and FoxP3+ cells in the TME, as measured by IHC (see “Methods”), were each associated with increased likelihood of response and prolonged PFS in both treatment arms (Supplementary Fig. 4a, b).