The purpose of this study is to evaluate the safety and clinical activity of FOLFIRINOX along
with a whole cell vaccine with immune modulating doses of cyclophosphamide and nivolumab
combined with Stereotactic Body Radiation Therapy (SBRT) in patients with pancreatic cancer.
- Have histologically proven pancreatic cancer that is borderline resectable
- No more than 1 month/cycle (28 days) of systemic therapy for pancreatic cancer
- Age >18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Patients must have adequate organ and marrow function defined by study-specified
- Woman of child bearing potential must have a negative pregnancy test.
- Must use an acceptable form of birth control while on study.
- Must be candidate for Stereotactic Body Radiation Therapy (SBRT)
- Ability to understand and the willingness to sign a written informed consent document.
- Had major surgery within the last 28 days
- Had an investigational drug or device within the past 28 days
- Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CTLA4, etc)
- Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
- Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2
- Other cancer diagnosis requiring treatment within two years
- History of allergic reactions related to the drugs (Nivolumab, Cyclophosphamide,
GM-hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin),
yeast or any other component of the GVAX vaccine) in this study.
- Patients receiving growth factors within the last 14 days.
- Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, psychological, immune or other medical conditions.
- Pregnant or breastfeeding.
- Have known history of infection with HIV, hepatitis B, or hepatitis C.
- Unwilling or unable to follow the study schedule for any reason.
- Presence of tissue or organ allograft, regardless of need for immunosuppression
(including corneal allograft)
- Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous