▪ Isolated grade 4 electrolyte imbalances/abnormalities that are not associated with clinical sequelae and are corrected with supplementation/appropriate management within 72 hours of their onset . ▪ Transient, self -correcting grade 4 AST or ALT that occur after the CRS -207 infusion and resolve s within 2 weeks . ▪ Grade 4 lymphopenia and leu kopenia . ▪ Grade 4 trea tment -related endocrinopathy adverse events, such as adrenal insufficiency, ACTH deficiency, hyper - or hypothyroidism, or glucose intolerance, which resolve or are adequately controlled with physiologic hormone replacement (corticosteroids, thyroid hormones) or glucose - controlling agents, respectively, may not require discontinuation after discussion with and approval from the Protocol Chair. • Any dosing interru ption lasting > 6 weeks with the following exceptions: ▪ Dosing interruptions to allow for prolonged steroid tapers to manage drug - related adverse events are allowed. Prior to re -initiating treatment in a subject with a dosing interruption lasting > 6 weeks, the Protocol Chair must be consulted. Tumor assessments should continue as per protocol even if dosing is interrupted. ▪ Dosing interruptions > 6 weeks that occur for non -drug-related reasons may be allowed if approved by the Protocol Chair . Prior to re -initiating treatment in a subject with a dosing interruption lasting > 6 weeks, the Protocol Chair must be consulted. Tumor assessments should cont inue as per protocol even if dosing is interrupted. Any AE, laboratory abnormality, or intercurrent illness which, in the judgment of the Investigator, presents a substantial clinical risk to the subject with continued nivolumab or nivolumab/ ipilimumab dosing. In order to standardize the management of AEs for all subjects, treatment management algorithms are included in Appendix B . Additional AE treatment management algorithms included in the nivolumab and ipilimumab IB might be considered for individ ual cases. Subjects that are required to stop treatment with nivolumab/ ipilimumab due to toxicity may stay on study and receive CY/GVAX Pancreas vaccine followed by CRS -207 ( assessment schedule per Section 10.2 ) once the nivolumab /ipilimumab -related toxicity(s) has resolved to a grade 1. J1790 / Version 7.0 / December 10, 2020 34 5. 1 1 End of Treatment (EOT) Visit All subject s will return to the study site 28 days (± 7 days) after the final study treatment (i.e., completion of the final course or upon early discontinuation) for an EOT evaluation . Procedures and assessments performed at these v isit s and beyond should follow the respective guidelines described in Sections 5. 1 2 and 10.0 as appropriate. If the EOT visit occurs early (e.g., 1 week prior to the expect ed visit as protocol allows) or if the patient cannot return due to disease progression , an assessment for AEs should be made by telephone or email on day 28 (± 1 day) after last dose of study drug and documented. 5. 1 2 Duration of Follow - Up All randomized subjects , including those never treated, will enter a follow - up period. Treated subjects will begin the follow - up period after they complete the EOT v isit. Subjects will be contacted every three months (+/ - 2 weeks) to monitor o verall s urvival until death, withdra wal of consent , or study closure. Information of other cancer therapies after discontinuation from the study treatment will be collected. Subjects will also be contacted at 100 days (+14 day reporting window) from the last dose of nivolumab/ipilimumab if the subject was still receiving nivolumab/ipilimumab at the time of treatment discontinuation to monitor drug toxicity. In addition, all subjects that received at least one dose of CRS - 207 will be monitored for CRS - 207 infection for one year per Section 5. 13 . S ubjects who discontinued study treatment without documented disease progression should continue to be monitored for disease status by radiologic imaging. Disease monitoring should continue to be assessed every two months (+/ - 2 weeks) until : 1) start of a new antineoplastic therapy (information of the new cancer therapy will be collected), 2) disease progression, 3 ) death, 4 ) withdrawal of consent, or 5 ) study closure, whichever occurs first. Subjects who are discontinued from the study treatment due to an unacceptable drug - related AE will be monitored for safety until the resolution of the AE to ≤ grade 1 or stabilization or until initiation of a new therapy for their cancer, whichever occurs first. All subjects will be followed after t heir last dose of study drug for the development of AEs and SAEs as described in Section 7.5.1 At the conclusion of the study, all remaining subjects who have received at least one dose of study treatment will be offered enrollment in a long - term follow - up study and continue to be evaluated for survival. Subjects who are still receiving treatment at the time of study close may complete the current treatment course (up to 6 cycles ) and EOT v isit prior to transitioning to participation in the separate long - term follow - up study . 5.13 Blood Cultures for CRS - 207 Surveillance J1790 / Version 7.0 / December 10, 2020 35 - 5.13.1 Confirmed Listeria Infection In the event a subject has a positive Listeria culture at any time during or after study participation (except within 7 days after a CRS - 207 infusion), the IND Sponsor should be notified within 24 hours of the adverse event of special interest (AESI) per S ection 7.1.3 . If Listeria has been confirmed at the clinical site or an external laboratory, all efforts should be made to obtain a sample of the bacterial isolate from the original positive culture and submit to the IND Sponsor or designee for strain co nfirmation; records on all samples cultured during this period must be obtained and provided to the Sponsor. Refer to the Central Laboratory Manual for sample collection and shipping instructions. 5.13.2 Suspected Infection with CRS - 207 or Listeria In t he case of a suspected persistent CRS - 207 or Listeria infection that has not been confirmed by culture, collection of blood (peripheral and port for those with indwelling ports) , urine and stool samples in duplicate is recommended. One set of samples shoul d be cultured locally for Listeria per institutional guidelines. Culture of cerebrospinal fluid should be obtained for subjects with suspected central nervous system infection. In such instances, analysis of cerebrospinal fluid should also include cell cou nt, protein, glucose, and Gram stain. If samples are positive for Listeria, the IND Sponsor must be notified immediately, and the duplicate samples and Listeria isolate must be sent to the IND Sponsor or designee for testing to confirm CRS - 207. Instruction s on collection, storage and shipping of samples for CRS - 207 testing are provided in the Central Laboratory Manual. 6. DOSING DELAYS/DOSE MODIFICATIONS 6.1 Dose Modifications Dose reduction or dose increase of CY, GVAX Pancreas vaccine , CRS - 207 , nivolumab , and ipilimumab will not be permitted . 6.2 Dosing Delays D osing of study therapy will be delayed for the following laboratory criteria: J1790 / Version 7.0/ December 10, 2020 36 • AST/ALT >3 × ULN • Total bilirubin > 1.5 x ULN or direct bilirubin > 2.0 × ULN for subjects with Gilbert ’s disease • Creatinine > 1.5 × ULN • Hemoglobin < 7.5 g/dL • ANC < 1000/uL • Platelets < 80 × 103/uL All scheduled cycles within a course are to be given approximately 3 weeks apart. If necessary, a scheduled cycle may be delayed for up to 1 week. In this case, subsequent cycles should continue so that a subject can still receive all 6 cycles given that the cycles are a minimum of 3 weeks apart and they have not experienced an AE necessitating discontinuation. If delayed more than 1 week, the Protocol Chair must be contacted for further instructions on continued treatment. Additional delays or modifications to the treatment schedule must be approved by the Protocol Chair or IND Sponsor. If a delay occur s between D ay 1 and 2 in a cycle: • Nivolumab and ipilimumab -related infusion reactions must resolve to baseline prior to administration of ipilimumab, GVAX , or CRS -207. • If a nivolumab -related infusion reaction prevents subsequent infusion of ipilimumab on the same day, the dose of ipilimumab should be replaced wi thin 72 hours. In such instances, at least 18 days must elapse between the replacement dose of ipilimumab and the administration of the next dose of nivolumab combined with ipilimumab. If the dose of ipilimumab cannot be replaced within 72 hours, resume ip ilimumab at the next scheduled dose per Section 10 . • Resume D ay 2 treatment schedule (GVAX or CRS -207) and assessments without repeating Day 1 study treatments (CY and/or nivolumab/ ipilimumab ) if the delay is within 72 hours . • If the delay is longer than 72 hours, repeat Day 1 and D ay 2 (if applicable) study treatments/assessments with a minimum of 2 weeks from the previous Day 1 treatment. This includes steroid treatment requiring at least a 14 day washout prior to resuming study - related treatments. Administration of study drug should be delayed for the following: • Dosing criteria are not met • Any grade ≥ 2 non -skin, treatment -related AE , with the following exceptions: o Grade 2 drug -related fatigue or laboratory abnormalities do not require a treatment delay o Grade 2 hypothyroidism or thyroiditis • Any grade >3 skin treatment -related AE • Any ≥ grade 3 treatment -related laboratory abnormality, with the following exceptions for asymptomatic amylase or lipase: o Grade 3 or 4 amylase or lipase abnormalities that are not associated with symptoms or clinical manifestations, or radiographic signs of pancreatitis do not require a dose delay. It is recommended to consult with the Protocol Chair for grade 3 amylase or lipase abnormalities. J1790 / Version 7.0/ December 10, 2020 37 o Isolated g rade 3 or 4 electrol yte imbalances/abnormalities that are not associated with clinical sequelae and are corrected with supplementation/appropriate management • Any AE, laboratory abnormality, or intercurrent illness which, in the judgment of the investigator, warrants delaying the dose of study drug. In order to standardize the management of AEs for all subjects, treatment management algorithms are included in Appendix B . Additional AE treatment management algorithms included in the nivolumab and ipilimumab IB might be considered for individual cases. Subjects may resume treatment with nivolumab and ipilimumab when the treatment -related AE (s) resolve to grade ≤1 or baseline value, with the following exceptions: • Subjects may resume treatment in the presence of grade 2 fatigue. • Subjects who have not experienced a Grade 3 drug -related skin AE may resume treatment in the presence of Grade 2 skin adverse event • Treatment -related pulmonary toxicity , diarrhea, or colitis must have resolved to baseline before treatment is resum ed. • Treatment -related endocrinopathies adequately controlled with only physiologic hormone replacement may resume treatment , which include grade 2 hyperglycemia, hypothyroidism and thyroiditis . 7. ADVERSE EVENTS: LIST AND REPORTING REQUIREMENTS This study will use the descriptions and grading scales found in the revised CTCAE version 4.03 for AE reporting that can be found at http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm . Information about all AEs, whether voluntee red by the subject, discovered by investigator questioning, or detected through physical examination, laboratory test or other means, will be collected, recorded, and followed as appropriate. 7.1 Definitions 7.1.1 Adverse Event An AE is defined as any undesirable sign, symptom or medical condition occurring after starting the study drug (or therapy) even if the event is not considered to be related to the study. An undesirable medical condition can be symptoms (e.g., nausea, chest pai n), signs (e.g., tachycardia, enlarged liver) or the abnormal results of an investigation (e.g. , laboratory findings, electrocardiogram). Medical conditions/diseases present before starting the study treatment are only considered AEs if they worsen after s tarting the study treatment (any procedures specified in the protocol). New medical conditions / diseases occurring before starting the study treatment but after signing the informed consent form will not be recorded as AEs . Additionally, expected progress ion of the disease being studied will not be recorded as an adverse event . J1790 / Version 7.0/ December 10, 2020 38 Laboratory abnormalities: Laboratory abnormalities present at the screening visit will be recorded as pre -treatment signs and symptoms. After study treatment administration, all grade 3 and 4 clinical laboratory results that represent an increase in severity from baseline will be reported as AEs. A grade 1 or 2 clinical laboratory abnormality should be reported as an AE only if it is considered clinically significant by the invest igator ( induce clinical signs or symptoms or require therapy ). 7.1.2 Serious Adverse Event A SAE is an undesirable sign, symptom or medical condition which: • Results in death • Is life threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) • Requires inpatient hospitalization or causes prolongation of existing hospitalization (see note below for exceptions) for >2 4 hours • Results in persistent or significant disability/incapacity • Is a congenital anomaly/birth defect (note: reports of congenital anomalies/birth defects must also be reported on the Pregnancy Form) • Is an important medical event (defined as a medical event(s) that may not be immediately life -threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the subject or may require intervention [e .g., medical, surgical] to prevent one of the other serious outcomes listed in the definition above.) Examples of such events include, but are not limited to, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or c onvulsions that do not result in hospitalization.) • Potential drug induced liver injury (DILI) is also considered an important medical event. • Hemophagocytic lymphohistiocytosis is also considered an important medical event. • Suspected transmission of an infectious agent (eg, pathogenic or nonpathogenic) via the study drug is an SAE. • Is a new cancer (that is not a condition of the study) • Is associated with an overdose • Is a pregnancy or pregnancy outcome of spontaneous abortion, missed abortion, benign hyda tidiform mole, blighted ovum, fetal death, intrauterine death, miscarriage, or stillbirth. Events not considered to be SAEs are hospitalizations for: • Admissions as per protocol for a planned medical/surgical procedure or to facilitate a procedure • Routine health assessment requiring admission for baseline/trending of health status (e .g., routine colonoscopy) • Medical/surgical admission for purpose other than remedying ill health state and was planned prior to entry into the study. Appropriate documentation is required in these cases . • Admission encountered for another life circumstance that carries no bearing on J1790 / Version 7.0/ December 10, 2020 39 health status and requires no medical/surgical intervention (e .g., lack of housing, economic inadequacy, care -giver respite, family circumstances, administrative). • Admissions for monitoring of treatment -related infusion reactions that do not otherwise meet the criteria for a SAE. 7.1.3 Adverse Events of Special Interest (AESI) Suspected infection with CRS -207 and/or Listeria are considered adverse events of special interest (AESI) and should be reported following SAE reporting procedures in Section 7.5 irrespective of temporal relationship to study drug administration. In the e vent a subject has a positive Listeria culture at any time during or after study participation , the event should be reported to the IND Sponsor within 24 hours of the event. All AESIs must be reported for the duration of the study regardless of causality. 7.2 Assessment of Causality The relationship of an AE to the administration of the study drug is to be assessed by the investigator according to the following definitions: • No (unrelated, not related, no relation) : The time course between the administ ration of study drug and the occurrence or worsening of the adverse event rules out a causal relationship and another cause (concomitant drugs, therapies, complications, etc.) is suspected. • Yes (related) : The time course between the administration of stu dy drug and the occurrence or worsening of the adverse event is consistent with a causal relationship and no other cause (concomitant drugs, therapies, complications, etc.) can be identified. The following factors should also be considered: • The temporal sequence from study drug administration - The event should occur after the study drug is given. The length of time from study drug exposure to event should be evaluated in the clinical context of the event. • Underlying, concomitant, intercurre nt diseases - Each report should be evaluated in the context of the natural history and course of the disease being treated and any other disease the subject may have. • Concomitant medication - The other medications the subject is taking or the treatment t he subject receives should be examined to determine whether any of them might be recognized to cause the event in question. • Known response pattern for this class of study drug - Clinical and/or preclinical data may indicate whether a particular response i s likely to be a class effect. • Exposure to physical and/or mental stresses - The exposure to stress might induce adverse changes in the recipient and provide a logical and better explanation for the event. • The pharmacology and pharmacokinetics of the stu dy drug - The known pharmacologic properties (absorption, distribution, metabolism, and excretion) of the study drug should be considered. J1790 / Version 7.0/ December 10, 2020 40 Assessment of Grade: The investigator will make an assessment of grade for each AE and SAE reported during the study, which will be recorded in the CRF. The assessment will be based on the National Cancer Institute’s CTCAE (Version 4.03) and graded as shown below: • Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated • Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age - appropriate instrumental activities of daily living • Grade 3: Severe or medically significant but not immediately life -threatening; hospitalization or prolon gation of hospitalization indicated; disabling; limiting self -care activities of daily living • Grade 4: Life -threatening consequences; urgent intervention indicated • Grade 5: Death related to AE Any AE that changes in grade during its course will be recorde d in the CRF at the highest level experience by the subject. 7.3 Expectedness Unexpected AE: An AE, which varies in nature, intensity or frequency from information on the investigational drug/agent provided in the product IB, package insert or safety rep orts. Any AE that is not included in the IB, package insert, safety reports or informed consent is considered “unexpected”. Expected (known) AE: An AE, which has been reported in the IB, package insert or safety reports . An AE is considered “expected”, only if it is included in the IB document as a risk. 7.4 Handling of Expedited Safety Reports In accordance with local regulations, the IND Sponsor or designee will notify investigators of all SAEs that are unexpected (i .e., not previously described in the IB), and related to CY, GVAX pancreas vaccine , CRS -207, nivolumab , or ipilimumab . This notification will be in the form of an expedited safety report (ESR) that is to be faxed to the investigators and the study coordinators. Upon receiving such notices, the investigator must review and retain the notice with the IB and where required by local regulations, the investigator will submit the ESR to the appropriate IRB. The investigator and IRB will determine if the informed consent requires revision. The investigator should also comply with the IRB procedures for report ing any other safety information. 7.5 Reporting 7.5.1 Adverse Events and Serious Adverse Events All AEs (both related and unrelated) will be captured on the appropriate study -specific CRFs. All AEs experienced by subjects will be collected and reported from the first dose of the investigational agent, throughout the st udy, and will be followed for 28 days after last dose of study drug unless related to the investigational agent. J1790 / Version 7.0 / December 10, 2020 41 Subjects who experience a grade 2 or higher nivolumab or ipilimu mab - related AE should be discussed with the Protocol Chair. Report AEs to the Protocol Chair and IND Sponsor within 24 hours once identified as an unacceptable toxicity (defined in Section 5.7). Elizabeth Jaffee : Dung Le: Report all AESI to the Protocol Chair and IND Sponsor within 24 hours once identified (defined in Section 7.1.3 ): Elizabeth Jaffee : Dung Le: All SAEs (including deaths) occur ring from the first dose of the study drug through 100 days (+ 14 day reporting window) after the last dose of nivolumab or ipilimumab or within 7 days prior to initiation of a new antineoplastic treatment (whichever comes first) will be collected and reported . If the subject never received or is no longer receiving nivolumab or ipilimumab due to toxicity, all SAEs (including deaths) occurring from the first dose of the study drug through 28 days from the last dose of cyclophosphamide, GVAX, or CRS - 207 ( whichever reporting period is longer) . All SAEs (including deaths) that the investigator considers related to study drug occurring after the follow - up periods must be reported. Subjects who have an ongoing AE/SAE related to the study procedures and/ or medication(s) may continue to be periodically contacted by a member of the study staff until the event is resolved or determined to be irreversible by the investigator. SAEs will be reported promptly to the IND Sponsor, and BMS within 24 hours of initi al notification of the SAE . If this falls on a weekend or holiday, an email notification is acceptable but must be followed by an SAE reporting form on the next business day. SAE reports and any other relevant safety information are to be sent to: Elizabeth Jaffee : Dung Le: BMS: 7.5.2 Follow - up of Adverse Events and Serious Adverse Events After the initial AE or SAE report, the investigator is required to proactively follow each subject and provide further information to the safety department in regards to the subject’s condition. All AE(s) and SAE(s) will be followed until: • Resolution • The condition stabilizes • The event is otherwise explained • The subject is lost to fo llow - up • Death J1790 / Version 7.0 / December 10, 2020 42 As soon as relevant information is available, a follow - up SAE report will be submitted to the IND Sponsor, and BMS. 7.5.3 Reconciliation of SAEs The Protocol Chair will reconcile the clinical database SAE cases (case level only) transmitted to the IND Sponsor and BMS Global Pharmacovigilance Frequency of reconciliation should be approximately every 3 months and prior to the database lock or final data summary. BMS GPV&E will email, upon request from the Investigator, the reconciliation report. Requests for reconciliation should be sent to The data elements listed on the BMS GPV&E reconciliation report will be used for case identification purposes. If the Sponsor determines a case was not transmitted to the IND Sponsor and BMS GPV&E, the case should be sent immedi ately to the IND Sponsor and BMS. 7.5. 4 Overdose An overdose is defined as the accidental or intentional administration of any dose of a product that is considered both excessive and medically important. All occurrences of overdose must be reported as SA Es. 7.5. 4 Potential Drug Induced Liver Injury (DILI) Wherever possible, timel y c onfirmation o f initial live r - related laboratory abnormalities should occu r prior to the reporting of a potential DILI event. All occurrences of potential DILIs, meeting the defined criteria, must be repo r ted as SAEs under the seriousness category checked as ‘other medically important e vent ’ . Potential drug induced liver injury is defined as: 1) ALT or AST elevation > 3 times upper limit of normal (ULN) AND 2) Total bilirubin > 2 times ULN, without initial findings o f cholestasis (elevated serum alkaline phosphatase) AND 3) No other immediate l y apparent possible causes o f AST/ALT elevation and h y perbilirubinemia, including, bu t no t limite d to , vira l hepatitis , pr e - existin g chroni c o r acut e live r disease , or the administration of other drug(s) known to be hepatotoxic. 7.5. 5 Pregnancy Reporting Although pregnancy and lactation are not always serious by regulatory definition , it is the responsibility of investigators or their designees to report any pregnancy or lactation in a subject (spontaneously reported to them) that occurs during the trial or within 5 months of completing the trial as an SAE . This also includ es the pregnancy of a male subject's female partner who has provided writt en consent to provide information regarding pregnancy, which occurs during the trial or within 7 months of completing the trial. J1790 / Version 7.0 / December 10, 2020 43 If a subject or partner of a subject participating in the study becomes pregnant, the investigator must report the pregnancy within 24 hours of discovery or knowledge of the event. To report a pregnancy, complete the S AE form with the seriousness category checked as ‘ o ther important medical event’ . When the form is completed, the IND Sponsor and BMS will be notified of the even t. All subjects or partners of subjects who become pregnant must be followed to the completion/termination of the pregnancy. If the pregnancy ends for any reason before the anticipated date, the investigator should notify the IND Sponsor and BMS . At th e completion of the pregnancy, the investigator will document the outcome of the pregnancy. Pregnancy outcomes of spontaneous abortion, missed abortion, benign hydatidiform mole, blighted ovum, fetal death, intrauterine death, miscarriage and stillbirth mu st also be reported as SAEs (Important Medical Events). If the pregnancy continues to term, the outcome (health of infant) must also be reported to the IND Sponsor and BMS . 7.