Safety and Efficacy of Combination Listeria/GVAX Pancreas Vaccine in the Pancreatic Cancer Setting

Inclusion Criteria:

- Have histologically proven malignant adenocarcinoma of the pancreas; measurable
disease is not required, mixed histology is not allowed; subjects must have metastatic
disease

- 2nd line, 3rd line or greater

- At least 18 years of age

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Anticipated life expectancy >12 weeks

- For women and men of childbearing potential, a medically acceptable method of highly
effective contraception (oral hormonal contraceptive, condom plus spermicide, or
hormone implants) must be used throughout the study period and for 28 days after their
final vaccine administration. A barrier method of contraception must be employed by
all subjects (male and female), regardless of other methods.

- Have adequate organ function as defined by specified laboratory values

Exclusion Criteria:

- Allergy to both penicillin & sulfa or suspected hypersensitivity to
granulocyte-macrophage colony stimulating factor (GM-CSF), dimethyl sulfoxide, fetal
bovine serum, trypsin, yeast, glycerol or other component of the therapy options

- Known history or evidence of brain metastases, immunodeficiency disease or
immunocompromised state or history of autoimmune disease requiring systemic steroids
or other immunosuppressive treatment

- Have any evidence of hepatic cirrhosis or clinical or radiographic ascites

- Have prosthetic heart valves, major implant or device placed in the last 12 months or
history of infection with implant/device that cannot be easily removed

- Rapidly progressing disease

- Clinically significant and/or malignant pleural effusion

- Received prior GVAX pancreas vaccine or CRS-207

- Major surgery or significant traumatic injury (or unhealed surgical wounds) occurring
within 28 days prior to receiving study drug, or planned surgery requiring general
anesthesia

- Infection with HIV or hepatitis B or C at screening

- Valvular heart disease that requires antibiotic prophylaxis for prevention of
endocarditis

- Pregnant or breastfeeding

- Unable to avoid close 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

- 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