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



Status:Recruiting
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 100
Updated:2/10/2019
Start Date:December 13, 2017
End Date:January 2023
Contact:Anna Ferguson, RN
Email:afergus1@jhmi.edu
Phone:4106147186

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A Phase II Clinical Trial of GVAX Pancreas Vaccine (With Cyclophosphamide) in Combination With Nivolumab and Stereotactic Body Radiation Therapy (SBRT) Followed by Definitive Resection for Patients With Borderline Resectable Pancreatic Adenocarcinoma

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.


Inclusion Criteria:

1. Have histologically proven pancreatic cancer that is borderline resectable

2. No systemic therapy for pancreatic cancer

3. Age >18 years old.

4. ECOG performance status 0-1.

5. Patients must have adequate organ and marrow function defined by study-specified
laboratory tests.

6. Woman of child bearing potential must have a negative pregnancy test.

7. Must use an acceptable form of birth control while on study.

8. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Had major surgery within the last 28 days

2. Had an investigational drug or device within the past 28 days

3. Prior treatment with immunotherapy agents (including, anti-PD-1, anti-PD-L1,
anti-PD-L2, anti-CTLA4, etc)

4. Prior treatment for pancreas cancer.

5. Patient on an immunosuppressive systemic treatments, such as steroids, in the past 2
years.

6. Other cancer diagnosis requiring treatment within two years

7. 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.

8. Patients receiving growth factors within the last 14 days.

9. Currently have or have history of certain study-specified heart, liver, kidney, lung,
neurological, psychological, immune or other medical conditions.

10. Pregnant or breastfeeding.

11. Have known history of infection with HIV, hepatitis B, or hepatitis C.

12. Unwilling or unable to follow the study schedule for any reason.
We found this trial at
2
sites
Baltimore, Maryland 21231
410-955-6190
Phone: 410-614-7186
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins The name Johns Hopkins has become synonymous...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Colin D Weekes, MD
Phone: 617-724-7000
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