Assessment of Causality/Relatedness of AEs ................................................................................. 55 Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page xvi LIST OF APPENDICES Appendix A M odified RECIST for Assessment of Response in MPM Appendix B Immune -related Response Criteria (irRC) Quick Reference Appendix C ALIMTA Prescribing Information Appendix D PLATINOL Prescribing Information Appendix E CYCLOPHOSPHAMIDE Prescribing Information Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page xvii LIST OF ABBREVIATIONS ActA Listeria monocytogenes protein encoded by actA gene AE adverse event ALT alanine aminotransferase ANC absolute neutrophil count APTT activated partial thromboplastin time AST aspartate aminotransferase BP blood pressure BSA body surface area BUN blood urea nitrogen CBC complete blood count CFR c ode of federal regulations CFU colony -forming unit CRF case report form CT computed tomography CTCAE c ommon terminology criteria for AEs CTM clinical trial material Cy cyclophosphamide DLTs d ose-limiting toxicities DTH delayed type hypersensitivity ECOG Eastern Cooperative Oncology Group EDC electronic data capture ELISPOT enzyme -linked immunosorbent spot FDA Food and Drug Administration FDG -PET fluorodeoxyglucose positron emission tomography FEV1 forced expiratory volume in 1 second FNA fine needle aspiration GM-CSF granulocyte -macrophage colony -stimulating factor HIV h uman immunodeficiency virus HLA human leukocyte antigen hMeso human mesothelin IB Investigator’s Brochure IBC institutional biosafety committee ICF informed consent form ICH i nternational conference on harmonisation InlB protein encoded by inlB gene IRB institutional review board irRC immune -related response criteria i.v. intravenous LDH lactate dehydrogenase Lm Listeria monocytogenes MPM malignant pleural mesothelioma MRI magnetic resonance imaging MTD maximum tolerated dose NCI National Cancer Institute NIH OBA National Institutes of Health Office of Biotechnology Activities PBMC peripheral blood mononuclear cel ls PHI protected health information p.o. per o ral PT prothrombin time RECIST r esponse evaluation criteria in solid tumors SAE serious adverse event SAP s tatistical analysis plan SOP standard operating procedure SPM study procedures manual UA urinalysis ULN upper limit of normal VC vital capacity WBC white blood cell Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 1 1.0 INTRODUCTION 1.1 BACKGROUND Malignant mesothelioma is a rare tumor that arises from mesothelial cells. Approximately 2,000 to 4,500 new cases of mesothelioma are diagnosed in the United States each year .