TREATMENT PLAN 5 .1 Agent Administra tion Treatment will be administered on an outpatient basis. Treatment schedule is described in Section J1790 / Version 7.0/ December 10, 2020 17 1.4. Dosing delays are described in Section 6 . No investigational or commercial agents or therapies other than those described below in Table 2 may be administered with the intent to treat the subject’s malignancy . Table 2: Regimen Description REGIMEN DESCRIPTION Agent Premedications; Precautions Dose Route Course Length CY Subjects may be pre -medicated with anti -emetics prior to CY administration. 200 mg/m2 in 100ml NS IV infusion over 30 min* 18 weeks GVAX EMLA cream (approximately 2.5 grams per site, at least 1 hour prior to vaccination) 5 × 108 cells Six intradermal injections CRS -207 650 mg acetaminophen; NS pre- and post-infusion to total 1500ml (suggested: 500ml pre and 1000ml post) . Subjects may also be pre -medicated with anti -emetics (suggested: IV ondansetron and IV fosaprepitant) . 1 × 109 CFU in 100ml NS IV infusion over 1 hour** Nivolumab No prophylactic pre-medication will be given unless indicated by previous experience in an individual subject per Section 5.3.4 . 360 mg IV infusion over 30 min* Ipilimumab No prophylactic pre-medication will be given unless indicated by previous experience in an individual subject per Section 5.3.4 . 1 mg/kg IV over 30 minutes* *Infusion times are approximate ( - 10/ + 15 min) and may need to be adjusted based on subject tolerability . **Infusion times are approximate ( ± 15 min) and may need to be adjusted based on subject tolerability. Please see Section 6.2 for guidance regarding dosing delays. If the investigator assesses a drug - related toxicity (that requires discontinuation ) to be related to an individual component of the treatment schedule, dosing for that study drug alone may be discontinued while dosing is delayed until the subject meets criteria to resume treatment of the other study drugs . The relationship to the discont inued study drug should be well documented in the source documents and permission from the Protocol Chair needs to be obtained prior to continuation with the other study drugs . 5.1.1 C yclophosphamide (CY) Subjects may be pre -medicated prior to adminis tration with anti -emetics per institutional J1790 / Version 7.0 / December 10, 2020 18 guidelines. Subjects should be observed for a minimum of 30 minutes before administration of nivolumab . Acute reactions resulting in the delay of nivolumab or ipilimumab will be managed using standard therapy for acute drug reactions as per institutional standard of care and reported to the Protocol Chair and IND Sponsor . Dosing calculation based on weight: The dosing calculations should be based on the body weight. If t he subject’s weight on the day of dosing differs by > 10% from the weight used to calculate the dose, the dose must be recalculated. 5.1.2 GVAX Pancreas Vaccine - 5.1.3 CRS - 207 Use of Central Lines - J1790 / Version 7.0 / December 10, 2020 19 - 5.1.4 Nivolumab - 5.1.5 Ipilimumab Antiemetic medications should not be routinely administered prior to dosin g of drugs. See Section 5. 2 .4 for subsequent premedicati on recommendations following an ipilimumab - related infusion reaction. 5 . 2 General Concomitant Medication and Supportive Care Guidelines 5. 2 .1 Cyclophosphamide (CY) Acute reactions will be managed using standard therapy for acute drug reactions as per institutional guidelines . 5.2.2 GVAX Pancreas Vaccine J1790 / Version 7.0/ December 10, 2020 20 Local vaccine site reaction may be treated with topical applications of aloe vera or vitamin E gel or lotion. Significa nt local inflammation that is causing the subject severe pain or is interfering with the activities of daily living may be treated with oral analgesics. Local toxicities of pruritus at the vaccine sites and systemic pruritus may be treated with topical or oral diphenhydramine hydrochloride (Benadryl®) or topical aloe vera. If oral diphenhydramine hydrochloride is used the recommended dose shall be 25 -50 mg every four to six hours as needed for pruritus, not to exceed 300 mg/day. Cases of local ulceration should be manageable with local wound care, with or without antibiotics.