Statistics
T-cell infiltration
The response-evaluable population, which was used for the efficacy analysis, comprised patients who received ≥1 dose of any study drug and completed a baseline scan. Patients in the response-evaluable population also had to have ≥1 post-baseline scan, been on study for ≥70 days, or discontinued study treatment. The safety population comprised patients who received ≥1 dose of any study drug. Efficacy and safety data collected during Phase I and Phase II were pooled and summarized using descriptive statistics (SAS v9.4 or later). No evaluation of the effect of treatment sequence was conducted. Changes in T-cell infiltration in pre- and on-treatment biopsies was compared using the Wilcoxon matched-pairs signed rank test in GraphPad Prism v7.02. The cutoff date for these analyses was February 15, 2019.