ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS .............................35 6.1 Definitions..............................................................................................................36 6.2 Relationship ...........................................................................................................37 6.3 Expectedness ..........................................................................................................39 6.4 Handling of Expedited Safety Reports ..................................................................39 6.5 Reporting................................................................................................................39 7. PHARMACEUTICAL INFORMATION ..........................................................................41 7.1 Cyclophosphamide (Cytoxan®, CY) ......................................................................41 7.2 GVAX ....................................................................................................................43 Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5 / January 17, 2018 57.3 Pembrolizumab ......................................................................................................46 8. CORRELATIVE/SPECIAL STUDIES .............................................................................48 8.1 Tumor Tissue Studies ............................................................................................48 8.2 Whole Blood Peripheral Bl ood Lymphocytes (PBLs)...........................................48 8.3 Serum and Plasma Marker Studies ........................................................................48 8.4 Diagnostic Tissue Samples ....................................................................................48 9.