J1790 / Version 7.0/ December 10, 2020 67 11. STUDY ENDPOINTS 11.1 Primary Endpoint The primary endpoint is ORR, which is defined as the proportion of subjects with PR or CR according to RECIST 1.1. Subjects who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non -responders. Subjects who discontinue for other reasons prior to their first dose of study drug will be replaced and not included in the primary efficacy analysis . 11.2 Secondary Endpoint The secondary endpoint is as follows: • Safety assessed by the following measures: – Number of pa tients who have grade 3 or higher drug-related toxicities – Frequency of drug-related toxicity by grade – Injection -site reactions (after GVAX pancreas vaccine injections only) – Nivolumab -related infusion reaction s – Ipilimumab -related infusion reactions – CRS -207-related infusion reaction s – Immune -related AEs – Unacceptable toxicities – Vital signs: BP, pulse, temperature – Physical examination – Changes in ECG readings – Clinical hematology: complete blood count (CBC) with differential ANC, ALC, AEC, and platelet count – Clinical serum chemistry: sodium, potassium, chloride, bicarbonate, glucos e, blood urea nitrogen (BUN), creatinine, lactate dehydrogenase (LDH), ALT, AST, alkaline phosphatase, amylase, bilirubin (total), total protein, albumin, calcium, magnesium and phosphate 11.3 Exploratory Endpoints Exploratory endpoints are as follows: • Overall survival (OS), duration of response, PFS measured by RECIST, immune - related progression -free survival (irPFS), and time to progression (TTP). − Overall survival (OS) is defined as the number of months from the date of randomization until death or end of follow -up (OS will be censored on the date the subject was last known to be alive for subjects without documentation of death at the time of analysis). − Progression -free survival (PFS) is defined as the number of months from the date of randomization to disease progression (PD or relapse from CR as assessed using RECIST 1.1 criteria) or death due to any cause. PFS will be censored at the date of the last scan for subjects without documentation of disease progression at the time of analysis. − Duration of Re sponse (DOR) is defined as the number of months from the first documentation of a response to date of disease progression. J1790 / Version 7.0/ December 10, 2020 68 − Time to -progression (TTP) is defined as the number of months from the date of randomization to the date of documented disease progre ssion (PD or relapse from CR as assessed using RECIST 1.1 criteria). It differs from PFS in that it does not include death in the definition of an event. TTP will be censored at the date of the last scan for subjects without documentation of disease progr ession at the time of analysis. • Tumor marker kinetics measured by change in serum CA19 -9 concentrations from baseline • Objective disease responses , progression -free survival, and duration of response measured by irRC • Humoral and cellular immune responses directed against Lm and mesothelin assessed by using the following measures: – ELISPOT or intracellular cytokine staining assays of PBMC – Induction of proinflammatory cytokines and chemokines in the serum – ELISA detection of mesothelin - and Lm-specific antibodies in the serum • Immune subset analyses by IHC and gene expression profiling of tumor tissue • Immune subset analyses in PBMCs including effector, helper, and regulatory T cells, NK cells, and macrophages • Telomere length of lymphocytes • Thyroglobulin and galectin -3 antibody responses • Microbial community analysis and whole metagenome functional profiling analysis of stool samples • Peripheral blood specimens, intratumoral core biopsy specimens, and resection specimens will be studied using a variety of laboratory techniques including but not limited to: immunohistochemistry (IHC), flow cytometry, CITE -Seq, RNA -Seq, whole exome sequencing, whole genome sequencing, T cell receptor and B cell receptor sequencing, ChIP -seq, ATAC -seq, and MBD -seq. 12.