‡ If considered standard of care in your region. • Should be performed every 8 weeks or as indicated on study calendars (section 6.0 and 6.1) Protocol: Version 8.0. September 19 , 2018 Page | 44 Laboratory tests for screening or entry into the Second Course Phase should be performed within 10 days prior to the first dose of treatment. After Cycle 1, pre -dose laboratory procedures can be conducted up to 72 hours prior to dosing. Results must be r eviewed by the investigator or qualified designee and found to be acceptable prior to each dose of trial treatment. 7.1.2.8 Pharmacokinetic/Pharmacodynamic Evaluations This study does not include Pharmacokinetic analysis. For Pharmacodynamic analysis see section 7.1.5 7.1.3 Other Procedures -Leukopheresis Mononuclear cell collection will be conducted by the Moffitt Cancer Center apheresis team. Patients presenting for apheresis must have been screened for soundness of health consistent with undergoing aphe resis. Females of child -bearing potential must also have been tested for pregnancy within the same time frame, per requirements of the FDA and American Association of Blood Banks. Patients must also have been tested within the preceding 30 days for infectious disease markers including HIV, Hepatitis, HTLV I/II (Human T Lymphotropic Virus), Hepatitis B, Hepatitis C and RPR (Rapid Plasma Reagin). At presentation for leukopheresis, patients will have their vital signs taken. Based on criteria that are outlined in standard operating procedures, patients are cleared to begin apheresis, or if failing the criteria, will be examined by qualified medical personnel. Patients will be connected to the apheresis instrument and associated disposables by bilateral venipuncture, generally in the median cephalic vein, using 18 gauge needles. Patients who do not have suitable veins to support apheresis will have to be assessed for placement of an indwelling catheter. Following initiation of apheresis, approximately 1 – 2 blood volumes will be processed using the mononuclear cell collection protocol. At the conclusion of apheresis, it is anticipated that approximately 50 - 200 mL of apheresis product will be retained, which should ideally contain at least 10 10 nucleated cells and less than 15 - 25 mL of RBC volume. 7.1.4 Withdrawal/Discontinuation When a subject discontinues/withdraws prior to trial completion, all activities scheduled for the final trial visit should be performed at the time of discontinuation. Any AEs which are present at the time of discontinuation/withdrawal should be followed in accordance with the safety requirements outlined in Section 7.2 (Assessing and Recording A Es). Subjects who a) attain a CR or b) complete 12 months of treatment with Ipi-Nivo and Nivo may discontinue treatment with the option of restarting treatment if they meet the criteria specified in Section 7.1.5.5. After discontinuing treatment following assessment of CR, these subjects should return to the site for a Safety Follow -up Visit (described in Section 7.1.5.3.1) and then proceed to the Follow-Up Period of the study (described in Section 7.1.5.4). Pr ot oc ol: Versi o n 8.