Individual trial procedures are described in detail below. It may be necessary to perform these procedures at unscheduled time points if deemed clinically necessary by the investigator. Furthermore, additional evaluations/testin g may be deemed necessary by the Sponsor and/ or BMS for reasons related to subject safety. In some cases, such evaluation/testing may be potentially sensitive in nature (e.g., HIV, Hepatitis C, etc.), and thus local regulations may require that additional informed consent be obtained from the subject. In these cases, such evaluations/testing will be performed in accordance with those regulations. 7.1.1 Administrative Procedures 7.1.1.1 Informed Consent The Investigator must obtain documented consent from each potential subject prior to participating in a clinical trial. 7.1.1.1.1 General Informed Consent Consent must be documented by the subject’s dated signature or by the subject’s legally acceptable representative’s dated signature on a consent form along w ith the dated signature of the person conducting the consent discussion. A copy of the signed and dated consent form should be given to the subject before participation in the trial. The initial informed consent form, any subsequent revised written informed consent form and any written information provided to the subject must receive the IRB/ERC’s approval/favorable opinion in advance of use. The subject or his/her legally acceptable representative should be informed in a timely manner if new inform ation becomes available that may be relevant to the subject’s willingness to continue participation in the trial. The communication of this information will be provided and documented via a revised consent form or addendum to the original consent form tha t captures the subject’s dated signature or by the subject’s legally acceptable representative’s dated signature. Specifics about a trial and the trial population will be added to the consent form template at the protocol level. The informed consent will adhere to IRB/ERC requirements, applicable laws and regulations and Sponsor requirements. 7.1.1.2 Inclusion/Exclusion Criteria All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee to ensure that the subject qualifies for the trial. Protocol: Version 8.0. September 19 , 2018 Page | 40 7.1.1.3 Medical History A medical history will be obtained by the investigator or qualified designee. Medical history will include all active conditions, and any condition diagnosed within the prior 10 years that are considered to be clinically si gnificant by the Investigator. Details regarding the disease for which the subject has enrolled in this study will be recorded separately and not listed as medical history. 7.1.1.4 Prior and Concomitant Medications Review 7.1.1.4.1 Prior Medications The investigator or qualified designee will review prior medication use, including any protocol- specified washout requirement, and record prior medication taken by the subject within 28 days before starting the trial. Treatment for the disease for which the subject has enrolled in this study will be recorded separately and not listed as a prior medication. 7.1.1.4.2 Concomitant Medications The investigator or qualified designee will record medication, if any, taken by the subject during the trial. All medications related to reportable SAEs and ECIs should be recorded as defined in Section 7.2. 7.1.1.5 Disease Details and Treatments 7.1.1.5.1 Disease Details The investigator or qualified designee will obtain prior and current details regarding disease status. 7.1.1.5.2 Prior Treatment Details The investigator or qualified designee will review all prior cancer treatments including systemic treatments, radiation and surgeries. 7.1.1.5.3 Subsequent Anti -Cancer Therapy Status The investigator or qualified designee will review all new anti- neoplastic therapy initiated after the last dose of trial treatment. If a subject initiates a new anti- cancer therapy within 30 days after the last dose of trial treatment, the 30 day Safety Follow -up visit must occur before the first dose of the new therapy. Once new anti-cancer therapy has been initiated the subject will move into survival follow -up. 7.1.1.6 Assignment of Screening Number Once a patient is enrolled in the study, he/she will be assigned a simple 3 digit number, with the first patient assigned to 001 and so on. A separate spreadsheet with password protection will be maintained that contains the patient study number along with personally identifiable information. Password protection will be maintained in order to keep patient information strictly confidential. U pon signing the informed consent form, the patient will be assigned a subject number by the investigator or his/her designee. Once assigned to a patient, a subject number will not be reused. If the patient fails to be started on treatment for any reason, t he reason will be entered on the Eligibility Tab in OnCore, and his/her demographic information Protocol: Version 8.0. September 19 , 2018 Page | 41 will be entered on the Demography Tab in OnCore. All laboratory, radiologic, and pathologic data collected on trial participants will be assigned the unique tre atment number and stored in the OnCore system database. 7.1.1.7 Assignment of Randomization Number Not applicable 7.1.1.8 Trial Compliance (Medication/Diet/Activity/Other) The Principal Investigator and the Clinical Research Coordinator assigned to the case will be primarily responsible for maintaining all study related documents including the clinical research forms. Oncore is the password protected, web- based electronic secure, database of record for all CRF entries and will be verified with source documentation. The review of medical records within the EMR will be done in a manner to assure that patient confidentiality is maintained. 7.1.2 Clinical Procedures/Assessments 7.1.2.1 Adverse Event (AE) Monitoring AEs will be collected from time of C1D1. The investigator or qualified designee will assess each subject to evaluate for potential new or worsening AEs as specified in the Trial Flow Chart and more frequently if clinically indicated. Adverse experiences will be graded and recorded throughout the study and during the follow -up period according to NCI CTCAE Version 4.0 ( see Appendix 11.2). Toxicities will be characterized in terms regarding seriousness, causality, toxicity grading, and action taken with regard to trial treatment. All AEs of unknown etiology associa ted with Ipi-Nivo or Nivo alone exposure should be evaluated to determine if it is possibly an event of clinical interest (ECI) of a potentially immunologic etiology (termed immune -related adverse events, or irAEs); see the separate ECI guidance document in Appendix 4 regarding the identification, evaluation and management of potential irAEs. Please refer to section 7.2 for detailed information regarding the assessment and recording of AEs. 7.1.2.2 Full Physical Exam The investigator or qualified designee wil l perform a complete physical exam during the screening period. Clinically significant abnormal findings should be recorded as medical history. A full physical exam should be performed during screening, 7.1.2.3 Directed Physical Exam For cycles that do not require a full physical exam per the Trial Flow Chart, the investigator or qualified designee will perform a directed physical exam as clinically indicated prior to trial treatment administration. Protocol: Version 8.0. September 19 , 2018 Page | 42 7.1.2.4 Vital Signs The investigator or qualified designee will take vital signs at screening, prior to the administration of each dose of trial treatment and at treatment discontinuation as specified in the Trial Flow Chart (Section 6.0). Vital signs should include temperature, pulse, respiratory rate, weight and blood pressure. Height will be measured at screening only. 7.1.2.5 Eastern Cooperative Oncology Group (ECOG) Performance Scale The investigator or qualified designe e will assess ECOG status (see Appendix 11.1) at screening, prior to the administration of each dose of trial treatment and discontinuation of trial treatment as specified in the Trial Flow Chart. 7.1.2.6 Tumor Imaging and Assessment of Disease Patients will undergo a CT Thorax and Abdomen at baseline, then every 2 cycles or the frequenc y indicated by the Trial Flow Chart (see section 6.0) . Radiographic assessments will be based on Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1, Appendix 11.3). Subjects with progressive disease by RECIST v1.1 but without rapid clinical deterioration may continue to be treated at the discretion of the investigator under the assumption that clinical benefit continues . 7.1.2.7 Laboratory Procedures/Assessments Details regarding specific laboratory procedures/assessments to be performed in this trial are provided below. Laboratory Safety Evaluations (Hematology, Chemistry and Urinalysis) Laboratory tests for hematology, chemistry, urinalysis, and others are specified in Table 5 . Protocol: Version 8.0. September 19 , 2018 Page | 43 Table 5 Laboratory Tests Hematology Chemistry Urinalysis Other Hematocrit Albumin Blood Serum β -human chorionic gonadotropin † Hemoglobin Alkaline phosphatase Glucose (β-hCG) † Platelet count Alanine aminotransferase (ALT) Protein PT (INR) WBC (total and differential) Aspartate aminotransferase (AST) Specific gravity aPTT Red Blood Cell Count Lactate dehydrogenase (LDH) Microscopic exam (If abnormal) Total thriiodothyronine (T3) Absolute Neutrophil Count Carbon Dioxide ‡ results are noted Free tyroxine (T4) Absolute Lymphocyte Count (CO 2 or biocarbonate) Urine pregnancy test † Thyroid stimulating hormone (TSH) Calcium Chloride Blood for correlative studies Glucose Potassium Sodium Magnesium Total Bilirubin Direct Bilirubin (If total bilirubin is elevated above the upper limit of normal) Total protein Blood Urea Nitrogen † Perform on women of childbearing potential only. If urine pregnancy results cannot be confirmed as negative, a serum pregnanc y test will be required.