0 Dead. Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 64APPENDIX B: Guidance for Identification and Treatment of IRAEs (Version 5.0, Date: 18-Dec-2014) Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 65 APPENDIX C: Adverse Event of Clinic al Interest (ECI) Reporting Form Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 66Adverse Event of Clinical Interest (ECI) Reporting Form Please notify: IND Sponsor within 24 hours ( , Merck within 24 hours ( Protocol Title: A Phase 2 Study of GVAX Colon V accine (with Cyclophosphamide) and Pembrolizumab in Patients with Mismatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer Protocol Number J16154 (MK-3475-485) Signature of PI: Principal Investigator: Dr. Nilofer Azad Date: Report Type: Initial Follow-up Final Follow-up Addendum to: Section A: Subject Information Subject ID: Subject Initial: Subject Gender: Male Female Section B: Event Information Event diagnosis or symptoms: Date of First Dose: Action taken with the study drug: None Interrupted Discontinued Delayed Pembrolizumab CY GVAX Date of Last Dose Prior to Event: Pembrolizumab CY GVAX Number of Total Doses: Pembrolizumab CY GVAX Event Onset Date: Event End Date: Date Event Discovered: Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 67Relationship to: Pembrolizumab CY GVAX Underlying Disease Unrelated Related Section C: Brief Descri ption of the Event: ( please include relevant proce dures and laboratory values) Section D: Relevant Medical History Section E: Concomitant Drug (Not related to ECI) Name of the Drug Start Date Stop Date Route Dose Frequen cy Section F: Comments Additional Documents: Please specify Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 68APPENDIX D: Serious Adverse Event (SAE) Reporting Form Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 69Serious Adverse Event Reporting Form Please notify: Dr. Zheng within 24 hours ( Merck within 24 hours ( ) Protocol Title: A Phase 2 Study of GVAX Colon V accine (with Cyclophosphamide) and Pembrolizumab in Patients with Mi smatch Repair-Proficient (MMR-p) Advanced Colorectal Cancer Protocol Number: J16154 (MK-3475-485) Signature of PI: Principal Investigator: Dr. Nilofer Azad Date: Report Type: Initial Follow-up Final Follow-up Death Addendum to: Serious Criteria (check all that apply): Death Life-threatening Hospitalization or Elongation of Existing Hospitalization Persistent or Significant Disability Congenital Anomaly Other Important Medical Event Cancer Overdose Hospital Admission Date: Hospital Discharge Date: Date Event Discovered: Section A: Subject Information Subject ID: Subject Initial: Subject Gender: Male Female Section B: Event Information Event diagnosis or symptoms: Date of First Dose: Action taken with the study drug: None Interrupted Discontinued Delayed Pembrolizumab CY GVAX Date of Last Dose Prior to Event: Pembrolizumab CY GVAX Number of Total Doses: Pembrolizumab CY GVAX Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 70Event Onset Date: Event End Date: Relationship to: Pembrolizumab CY GVAX Underlying Disease Unrelated Related Section C: Brief Descri ption of the Event: Section D: Relevant Medical History Section E: Concomitant Drug (Not related to SAE) Name of the Drug Start Date Stop Date Route Dose Freque ncy Section F: Comments Additional Documents: Please specify Phase 2 Study of GVAX (with CY) and pembrolizum ab in MMR-p advanced colorectal cancer J16154/Version 5/ January 17, 2018 71APPENDIX E: Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Criteria for Evaluating Response in Solid Tumors RECIST version 1.1 will be used in this study for assessment of tumor response. While either CT or MRI may be used utilized, as per RECIST 1.1, CT is the pref erred imaging tec hnique in this study.