GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer

Phase 2

Completed

Interventions: Drug: Cyclophosphamide
Drug: Nivolumab
Drug: GVAX Pancreas Vaccine
Radiation: Stereotactic Body Radiation (SBRT)

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

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 laboratory tests.
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.

Exclusion Criteria

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 years.
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 cells >30%

Arm && Interventions

Group	Intervention	Description
CY, Nivolumab, GVAX, and SBRT	Cyclophosphamide	CY, Nivolumab, GVAX, and SBRT
CY, Nivolumab, GVAX, and SBRT	Nivolumab	CY, Nivolumab, GVAX, and SBRT
CY, Nivolumab, GVAX, and SBRT	GVAX Pancreas Vaccine	CY, Nivolumab, GVAX, and SBRT
CY, Nivolumab, GVAX, and SBRT	Stereotactic Body Radiation (SBRT)	CY, Nivolumab, GVAX, and SBRT

Primary Outcome Measures

Name	Time	Method
CD8+ T Cell Density in Tumor Tissue	evaluated at time of surgery, approximately 2 months from first dose of study drug	Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).

Secondary Outcome Measures

Name	Time	Method
Pathologic Complete Response (pCR) Rate at Surgical Resection	Assessed at time of surgical resection, approximately 2 months after first dose of study drug	Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation.

Locations (2): Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸
Baltimore, Maryland, United States
Medical College of Wisconsin
🇺🇸
Milwaukee, Wisconsin, United States