Phase 2
N=31
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03161379 ↗Enrolled (actual)
31
Serious AEs
16.7%
Results posted
Feb 2025
Primary outcome: Primary: CD8+ T Cell Density in Tumor Tissue — 5.4 log (cells per mm^2)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Nivolumab (Drug); GVAX Pancreas Vaccine (Drug); Stereotactic Body Radiation (SBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CD8+ T Cell Density in Tumor Tissue |
5.4 | — |
| SECONDARY Pathologic Complete Response (pCR) Rate at Surgical Resection |
1 | — |
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.
Eligibility 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%
Data sourced from ClinicalTrials.gov (NCT03161379). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.