Pancreatic CancerPhase 2NCT03161379
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
A Phase 2 study testing Cyclophosphamide, Nivolumab and GVAX Pancreas Vaccine in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- Cyclophosphamide, Nivolumab and GVAX Pancreas Vaccine
- Type of treatment
- Vaccines, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Feb 2018to 28 Feb 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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%
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
About this study
Official title: 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.
- Conditions
- Pancreatic Cancer
- Being tested
- Cyclophosphamide, Nivolumab, GVAX Pancreas Vaccine, Stereotactic Body Radiation (SBRT)
- Keywords
- Neoadjuvant therapy, immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, SBRT, GVAX, Nivolumab, borderline resectable, Radioimmunotherapy, Vaccine, Antibody, Anti-PD-1
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called CY
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.
NivolumabDrug
Also called OPDIVO
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.
GVAX Pancreas VaccineDrug
Also called PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo 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.
Stereotactic Body Radiation (SBRT)Radiation
SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).
| Study group | Role | What they receive |
|---|---|---|
| CY, Nivolumab, GVAX, and SBRT | Experimental | CY, Nivolumab, GVAX, and SBRT Receives: Drug: Cyclophosphamide; Drug: Nivolumab; Drug: GVAX Pancreas Vaccine; Radiation: Stereotactic Body Radiation (SBRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8+ T Cell Density in Tumor Tissue
Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC).
Measured: evaluated at time of surgery, approximately 2 months from first dose of study drug
Secondary outcomes (1)
Pathologic Complete Response (pCR) Rate at Surgical Resection
Number of patients with a pathologic complete response (pCR) rate at surgical resection. A pCR is defined as no viable residual tumor remaining at the time of evaluation.
Measured: Assessed at time of surgical resection, approximately 2 months after first dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start2 Feb 2018
- Primary completion20 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Daniel Laheru, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsArsen Osipov, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161379
- Sponsor's protocol ID
- J1756
- Other IDs
- IRB00130075
- Status last verified
- Jan 2025
- First submitted
- 18 May 2017
- Last updated
- 3 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03161379
- Acronym / sponsor ID
- J1756
- Conditions
- Pancreatic Cancer
- Keywords
- Neoadjuvant therapy, immunotherapy, Cytoxan, Cyclophosphamide, Pancreatic Vaccine, SBRT, GVAX, Nivolumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 2 Feb 2018 (actual)
- Primary completion
- 20 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 19 May 2017 (actual)
- Results
- Posted 3 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CY, Nivolumab, GVAX, and SBRT | Experimental | Drug: Cyclophosphamide, Drug: Nivolumab, Drug: GVAX Pancreas Vaccine, Radiation: Stereotactic Body Radiation (SBRT)CY, Nivolumab, GVAX, and SBRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CyclophosphamideAlso: CYCyclophosphamide 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. | Drug | CY, Nivolumab, GVAX, and SBRT |
| NivolumabAlso: OPDIVONivolumab (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. | Drug | CY, Nivolumab, GVAX, and SBRT |
| GVAX Pancreas VaccineAlso: PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccineVaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given. | Drug | CY, Nivolumab, GVAX, and SBRT |
| 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). | Radiation | CY, Nivolumab, GVAX, and SBRT |
Primary outcome
CD8+ T Cell Density in Tumor Tissue
Time frame: evaluated at time of surgery, approximately 2 months from first dose of study drug
Mean CD8+ T cell density [log(cells per mm^2)], found in resected surgical tissue by Immunohistochemistry (IHC).
1 secondary outcome
Pathologic Complete Response (pCR) Rate at Surgical Resection
Time frame: Assessed at time of surgical resection, approximately 2 months after first dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Laheru, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Arsen Osipov, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cyclophosphamide, Nivolumab and GVAX Pancreas Vaccine in people with Pancreatic Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CD8+ T Cell Density in Tumor Tissue (time frame: evaluated at time of surgery, approximately 2 months from first dose of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.