Tissue blocks will be stored at room temperature. The tissue that will be used for gene expression analysis will be stored immediately after collection in at least 5 volumes of RNAlater® solution. The sample s will be stored overnight at 4°C and transferred to -70°C or colder for long- term storage until RNA isolation. Samples obtained at N CI will be stored by the Molecular Pharmacology Program (Building 10, Room 5A01; William Figg, Pharm.D) Please consult laboratory manual for shipping instructions. Testing Sites IHC analysis will be performed at the Laboratory of Pathology at NCI to determine mesothelin expression within the tumor. Furthermore, collected tumor tissue will be assessed for CD4+ and CD8+ T cell infiltration as well as the presence of regulatory T cells (FoxP3+). Additional markers might be assessed. Tumor expression analy sis will be performed on the isolated RNA from tumor biopsy tissue as previously described. 48 Gene expression profiling of tumor tissue samples will be conducted by Aduro. 5.3.4 Blood Cultures for CRS -207 Surveillance Blood samples from subject’s peripheral vein will be obtained at EOS to monitor for presence of CRS -207. For subjects with a central line port, a blood sample will also be taken through the port. Subjects with samples positive for the presence of CRS -207 will initiate IV antibiotics per Section 5.2.2.5 and be re - tested until negative cultures are confirmed. See Section 6.8.1 for additional information on suspected CRS-207 or Listeria infection. Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 50 6.0 PROCEDURES FOR HANDLING AES AND SAES 6.1 DEFINITION OF AN ADVERSE EVENT The following definition of an AE will be used for this study: Any untoward medical occurrence in a subject administered an investigational product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to medicinal (investigational) product. Examples of AEs include the following: • Significant or unexpected worsening or exacerbation of the indication under study • Exacerbation of a chronic or intermittent preexisting condition, including an increase in frequency or intensity of the condition • New conditions detected or diagnosed after investigational product administration, even if they were present before the start of the study • Signs, symptoms, or the clinical sequelae of a suspected interaction with another medical product • Signs, symptoms, or the clinical sequelae of a suspected overdose of either investigatio nal product or a concurrent medication An overdose should not be reported as an AE or SAE; instead the symptoms resulting from the overdose should be reported as the AE or SAE. Examples of AEs do not include the following: • Medical or surgical procedures (e.g. endoscopy, appendectomy) (Instead, the medical condition that led to the procedure is an AE.) • Situations that are unwanted but in which an untoward medical occurrence did not occur, for example social inconvenience after admission to a hospital Aduro Biotech , Inc. Protocol ADU -CL-02-v8 CRS -207 with Pemetrexed and Cisplatin Version 8, 08 March 2018 Page 51 • Anticip ated day -to-day fluctuations of a preexisting disease or condition (present or detected before enrollment) that does not worsen overall • Expected progression of the disease being studied, including signs or symptoms of the disease being studied, unless progression is more severe than expected for the subject’s condition It is the responsibility of the investigator to perform periodic and special assessments for AEs. The investigator and clinical staff will note all AEs offered by the subject at baseline, during administration of the CTM, and at the follow -up visit. All clinical complaints volunteered by, or elicited from, the subject during the study will be recorded on the appropriate page of the CRF for the study period indicated. If any AE occurs, the s ubject will receive appropriate treatment and medical supervision. All AEs judged to be clinically significant, including clinically significant laboratory abnormalities, will be followed until resolution. All AEs will be summarized in the annual report or more frequently, if requested by the regulatory agency. SAEs require special reporting in addition to documentation in the CRF as described below. 6.2 DEFINITION OF A SERIOUS ADVERSE EVENT (SAE) In this study, the definition of an SAE is an AE that mee ts any of the following criteria: • Results in death • Is life -threatening Note: The term life-threatening in the definition of serious refers to an event in which the subject was at risk of death at the time of the event. It does not refer to an event that hypothetically might have caused death if it were more severe.