Protocol Version 8.0. September 19 , 2018 Page | 56 9.0 LABELING, PACKAGING, STORAGE AND RETURN OF CLINICAL SUPPLIES 9.1 Investigational Products The investigator shall take responsibility for and shall take all steps to maintain appropriate records and ensure appropriate supply, storage, handling, distribution and usage of investigational product in accordance with the protocol and any applicable laws and regulations. 9.1.1 Clinical Supplies provided by BMS as summarized in Table 7 . Table 7 Product Descriptions Product Description/Class and Dosage Form IP/Non - IMP Potency Packaging/ Appearance Storage Conditions (per label) Nivolumab Solution for Injection IP 100 mg (10 mg/mL) 10 mL/vial (5 or 10 vials/carton) Store at 2 -8°C; protect from light and freezing Ipilimumab Solution for Injection IP 200 mg (5 mg/mL) 40 mL/vial (4 vials/carton) Store at 2 -8°C; protect from light and freezing 9.1.2 Clinical Supplies provided by Moffitt Cell Therapy Facility Adp53- DC (see Appendix 11.4) 9.2 Packaging and Labeling Information Clinical supplies will be affixed with a clinical label in accordance with regulatory requirements. 9.3 Clinical Supplies Disclosure This trial is open -label; therefore, the subject, the trial site personnel, the Sponsor and/or designee are not blinded to treatment. Drug identity (name, strength) is included in the label text; random code/disclosure envelopes or lists are not provided. 9.4 Storage and Handling Requirements The product storage manager should ensure that the study drug is stored in accordance with the environmental conditions (temperature, light, and humidity) as outlined in the investigator’s brochure. If concerns regarding the quality or appearance of the study drug arise, the study drug should not be dispensed and contact the principal investigator and BMS immediately. Study drug not supplied by BMS will be stored in accordance with the package insert (in this case in accordance with Moffitt Cell Therapy Laboratory). Please refer to Section 10.2.2 for guidance on IP records and documentation. Infusion- related supplies (eg, IV bags, in- line Protocol Version 8.0. September 19 , 2018 Page | 57 filters, 0.9% sodium chloride injection, 5% dextrose injection) will not be supplied by the sponsor and should be purchased locally if permitted by local regulations. Please refer to the current version of the Investigator Brochure (IB) and/or pharmacy reference sheets for complete storage, handling, dispensing, and infusion information for nivolumab and ipilimumab. The infusion duration of nivolumab is 30 minutes and for ipilimumab is 90 minutes. Clinical supplies must be stored in a secure, limited -access location under the storage conditions specified on the label. Receipt /dispensing of trial medication mus t be recorded by authorized person at the trial site. Clinical supplies may not be used for any purpose other than that stated in the protocol. 9.5 Returns and Reconciliation The investigator is responsible for keeping accurate records of the clinical suppl ies received from BMS or designee, the amount dispensed to and returned by the subjects and the amount remaining at the conclusion of the trial. Upon completion or termination of the study, all unused and/or partially used investigational product will be destroyed at the site per institutional policy. It is the Investigat or’s respons ibility to arrange for disposal of all empty containers, provided that procedures for proper disposal have been established according to applicable federal, state, local and i nstitutional guidelines and procedures, and provided that appropriate records of disposal are kept. 10.0 DATA SA DATA SAFETY MONITORING PLAN 10.1 Risk to Subjects 10.1.1 Human subject involvement and characteristics Human subjects who have the diagnosis of advanced NS CLC are eligible to participate in the clinical trial described in this proposal. The risk to subjects will be outlined clearly and in detail in the informed consent. Women who are pregnant are not eligible. 10.2 Recruitment and Informed Consent Patients who present to the Thoracic Oncology Program at the Moffitt Cancer Center or the OSU Thoracic Clinics who have advanced NSCLC are offered participation in the clinical trial described in this proposal. The trial is explained in detail to the patients by one of the investigators on the trial.