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

• Status: Active, not recruiting
• Trial end date: 2023-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborator: Bristol-Myers Squibb
• Treatments: Antibodies, Monoclonal; Cyclophosphamide; Nivolumab; Pancreatin; Pancrelipase; Vaccines

Criteria

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%