Epacadostat, Pembrolizumab, and CRS-207, With or Without CY/GVAX Pancreas in Patients With Metastatic Pancreas Cancer

Inclusion Criteria (abbreviated):

- Documented adenocarcinoma of the pancreas

- Have disease progression after prior chemotherapy for metastatic pancreas cancer (or
adjuvant or neoadjuvant if progression occurred within 6 months of completing this
regimen)

- Presence of at least one measurable lesion

- Patient acceptance to have a tumor biopsy of an accessible lesion at 2 time points
(baseline and on study)

- ECOG performance status of 0 or 1

- Life expectancy of greater than 3 months

- Adequate organ and marrow function defined by study-specified laboratory tests

Exclusion Criteria (abbreviated):

- Brain metastases

- Clinical or radiographic ascites (some trace amount may be allowed)

- Rapidly progressing disease

- Live vaccine within 30 days of study treatment (flu vaccine allowed)

- Surgery within 28 days of study treatment (some exceptions for minor procedures)

- Use of an investigational agent or device within 28 days of study treatment.

- Chemotherapy, radiation, or biological cancer therapy within 14 days of study
treatment.

- Prior treatment with anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti PD-L2, or with IDO
inhibitor.

- Use of growth factors within 14 days of study treatment

- Use of any systemic steroids within 14 days of study treatment or other
immunosuppressive agents within 7 days of study treatment.

- Use of more than 2 g/day of acetaminophen

- Use of any UGT1A9 inhibitor

- Use of warfarin

- Use of MAOIs or drugs with significant MAOI activity within the 21 days of screening

- History of Seratonin Syndome

- Known allergy to both penicillin and sulfa

- Known or suspected hypersensitivity to any monoclonal antibody or any study drug
component

- Have artificial joints or implants that cannot be easily removed or a history of
infection associated with an implant

- Significant or malignant pleural effusion

- New pulmonary embolism, extremity deep venous thromboembolism, or portal vein
thrombosis within 2 months of study enrollment

- History of autoimmune disease (exceptions for Graves or Hashimoto's disease, vitiligo,
and type I diabetes mellitus)

- Gastrointestinal condition that may affect drug absorption

- Significant heart disease or heart disease requiring antibiotic for prevention of
endocarditis

- History of abnormal electrocardiogram (ECG) that is deemed meaningful by the
investigator

- History of (non-infectious) pneumonitis that required steroids, evidence of
interstitial lung disease or active, non-infectious pneumonitis

- Pulse oximetry of < 92% on room air or the need for supplemental home oxygen

- Infection with HIV, hepatitis B or hepatitis C

- Other 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

- Pregnant or breastfeeding women

- Unwillingness or inability to follow the study schedule for any reason