Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer

Inclusion criteria

• Age ≥18 years.
• Have histologically or cytologically proven adenocarcinoma of the pancreas.
• Have metastatic disease.
• Have disease progression.
• Patients with the presence of at least one measurable lesion.
• Patient's 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
• Had chemotherapy, radiation, or biological cancer therapy within the last 14 days
• Have received a prophylactic vaccine within 14 days or received a live vaccine within 30 days of planned start of study therapy.
• Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2,or anti-CTLA4
• Systemic steroids within the last 14 days
• Use more than 2 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 clinical or radiographic ascites.
• Have significant and/or malignant pleural effusion
• Have had a new pulmonary embolism, extremity deep venous thromboembolism, or portal vein thrombosis within 2 months of study treatment
• 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
• Are pregnant or breastfeeding.
• Have rapidly progressing disease