GVAX Pancreas Vaccine (With CY) and CRS-207 With or Without Nivolumab

Inclusion Criteria

• Age ≥18 years.
• Have histologically- or cytologically-proven adenocarcinoma of the pancreas. Patients with mixed histology will be excluded.
• Have metastatic disease.
• Have failed only 1 prior chemotherapy regimen for metastatic pancreatic cancer.
• Patients with the presence of at least one measurable lesion.
• Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
• ECOG performance status 0 or 1.
• Life expectancy of greater than 3 months.
• Patients must have adequate organ and marrow function defined by study-specified laboratory tests.
• Must use acceptable form of birth control while on study.
• Ability to understand and willingness to sign a written informed consent document.

Exclusion Criteria

• known history or evidence of brain metastases.
• Had surgery within the last 28 days
• Have received any non-oncology vaccine therapy used for prevention of infectious diseases including seasonal vaccinations within 28 days of study treatment.
• Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4, GVAX or CRS-207
• Systemic steroids within the last 14 days
• Use more than 3 g/day of acetaminophen.
• Patients on immunosuppressive agents.
• Patients receiving growth factors within the last 14 days
• Known allergy to both penicillin and sulfa.
• Severe hypersensitivity reaction to any monoclonal antibody.
• Have artificial joints or implants that cannot be easily removed
• Have any evidence of hepatic cirrhosis or clinical or radiographic ascites.
• Have significant and/or malignant pleural effusion
• Infection with HIV or hepatitis B or C at screening
• Significant heart disease
• Conditions, including alcohol or drug dependence, intercurrent illness, or lack of sufficient peripheral venous access, that would affect the patient's ability to comply with study visits and procedures
• Unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS-207 treatment until completion of antibiotic regimen.
• Are pregnant or breastfeeding.
• Have rapidly progressing disease