Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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%

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Masking Description
Open Label

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CY, Nivolumab, GVAX, and SBRT
CY, Nivolumab, GVAX, and SBRT
  • Drug: Cyclophosphamide
    Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
    Other names:
    • CY
  • Drug: Nivolumab
    Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
    Other names:
    • OPDIVO
  • Drug: GVAX Pancreas Vaccine
    Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.
    Other names:
    • PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine
  • Radiation: Stereotactic Body Radiation (SBRT)
    SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).

More Details

Status
Completed
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.