Each arm will be evaluated independently. The benchmark for the es timate of ORR is based on a recent study of metastatic pancreatic cancer patients who had failed one prior gemcitabine -based regimen where patients who received nanoliposomal irinotecan plus fluorouracil and folinic acid had a response rate of 16% (19/177) . Response rates for patients receiving either nanoliposomal irinotecan monotherapy or fluorouracil and folinic acid were between 1 -6%. Statistical Analyses Data will be summarized descriptively by treatment arm and overall. The descriptive summary including demographics and baseline variables will include counts and percentages for categorical variables and means, medians, standard deviations and minimum and maximum values for continuous variables. Time -to-event outcomes such as OS will be analyze d using Kaplan -Meier estimates (to obtain medians with 95% CI as well as plotting survival curves), log -rank tests, and Cox proportional hazards models. Comparisons between the two treatment arms will be exploratory in nature due to the small sample size. Where applicable, comparisons between groups will be made using a Chi - square test or logistic regression for binary variables and t -tests or analysis of covariance (ANCOVA) or linear regression models for continuous variables. Non -parametric alternatives (e.g. Fisher’s exact test or Kruskal -Wallis tests) will be considered as needed as will transformations of the outcome variables (e.g. log). For correlative studies, plots will be used to show the changes in immune response over time both for each indiv idual and for each treatment group. For each treatment, comparisons in the pre and post-treatment responses will be compared using paired t -tests (or Wilcoxon signed rank tests if appropriate) for continuous variables and McNemar’s tests for dichotomous or categorical variables. Associations between immune parameters will be explored graphically (e.g. scatterplots, boxplots) and numerically (e.g., correlations, Fisher’s exact tests). Regression techniques will be used to explore the differences between the treatment arms for cross -sectional data (e.g., linear and logistic regression) and longitudinally with appropriate correction for correlation between repeated measurements (e.g., GEE and linear mixed effects models). All statements of statistical signific ance will be based on a 2 -tailed test with an overall 0.05 level of significance, unless stated otherwise. All confidence intervals will be 95%, unless stated otherwise. Sensitivity analyses will include models adjusting for baseline covariables. These J1790 / Version 7.0/ December 10, 2020 74 covariates will be selected based upon both clinical significance and potential imbalances between the treatment arms . Timing of Analysis The primary analysis will be conducted when all treated subjects have documented response or progression by RECIST 1.1, or have discontinued the study. 13.2 Analysis Sets The Full Analysis Set (FAS) includes all randomized subjects who received at least one dose of study treatment. FAS analyses will be conducted on the basis of the randomized treatment. Since the focus of this study is on establishing the efficacy of the treatment combinations, all efficacy outcomes will be assessed using the FAS as the primary population for analysis. The Intent to Treat (ITT) analysis set includes all randomized subjects, regard less of the amount or type of treatment received. It is distinguished from the FAS in that individuals who do not receive any doses of study treatment will be included and therefore focuses upon the effectiveness of the treatment combinations. ITT analyse s will be conducted on the basis of the randomized treatment. This population will be used for sensitivity analyses of OS and other selected efficacy endpoints. The safety population includes all randomized subjects who received at least one dose of study treatment. The safety population will be conducted on the basis of the actual treatment received. All safety outcomes will be assessed using the safety population for analysis. A Per -Protocol (PP) subset may also be used to analyze select efficacy endpoi nts and will be based on study treatment exposure (compliance and/or time on study treatment) and major protocol deviations. The criteria for inclusion in the PP subset will be finalized and documented prior to database lock. 13.3 Safety Analysis The saf ety analysis will be performed in all treated subjects. AE data will be listed individually and incidence of AEs summarized by system organ class and preferred terms within a system organ class for each treatment group. When calculating the incidence of A Es, each AE (based on preferred terminology defined by CTCAE version 4.03 ) will be counted only once for a given subject. In analyses of grade and causality, if the same AE occurs on multiple occasions, the highest grade and strongest relationship to stud y drug will be assumed. If 2 or more AEs are reported as a unit, the individual terms will be reported as separate experiences. Vaccine -site reactions will be listed and tabulated separately from the AEs. Changes in vital signs, hematology and clinical chemistry parameters from baseline to the end of the study will be examined. Toxicity will be tabulated by type and grade. Toxicities will be characterized according to the CTCAE version 4.03. Treatment -emergent changes from normal to abnormal values in key laboratory parameters will be identified. J1790 / Version 7.0/ December 10, 2020 75 REFERENCES 1 Siegel, R. L., Miller, K. D. & Jemal, A. Cancer statistics, 2016. CA: a cancer journal for clinicians 66, 7-30, doi:10.3322/caac.21332 (2016). 2 Torre, L.