NCT03161379CompletedPhase 2
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
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
Source: ClinicalTrials.gov · Last updated 3 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- First submitted
- 18 May 2017
- Start date
- 2 Feb 2018
- Primary completion date
- 20 Feb 2024
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Diseases
- Pancreatic cancer
- NCT number
- NCT03161379
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 31
- From 2 Feb 2018 to the primary completion date, 20 Feb 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Patient on an immunosuppressive systemic treatment, such as steroids, in the past 2 years.
- Patients receiving growth factors within the last 14 days.
Other illness
- Completed more than 1 month/cycle (28 days) of chemotherapy for pancreas cancer
- Other cancer diagnosis requiring treatment within two years
- Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, psychological, immune or other medical conditions.
- Have known history of infection with HIV, hepatitis B, or hepatitis C.
- Squamous pancreatic cancer or adenosquamous pancreatic cancer with malignant squamous cells \>30%
Lab values
- 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.
Other
- Pregnant or breastfeeding.
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.