Triple threat: new combo aims to stop pancreatic cancer spread
NCT ID NCT02648282
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tested a combination of a pancreatic cancer vaccine (GVAX), an immunotherapy drug (pembrolizumab), and focused radiation (SBRT) in 58 patients with locally advanced pancreatic cancer. The goal was to see if this approach could delay the spread of the cancer to other parts of the body. Participants had already received standard chemotherapy before joining the study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- pancreatic cancer vaccine (GVAX) plus pembrolizumab (immunotherapy) and stereotactic body radiation therapy (SBRT)
- What this could lead to
- If successful, this combination could delay or prevent the spread of pancreatic cancer, offering a new treatment option for patients with locally advanced disease.
- What could go wrong
- This is a small, early-phase trial (58 participants) with no control group, so results may not be definitive. The combination therapy carries risks of serious side effects, including immune-related toxicities.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
58 people
The number who actually took part.
- Started
-
Jul 2016
- Finished
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Jun 2022
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Locally advanced pancreatic adenocarcinoma 2. Patients must have received mFOLFIRINOX or Gemcitabine/ Abraxane based chemotherapy for 4 cycles with last dose of therapy between 2-5 weeks of study enrollment. 3. Age \>18 years 4. No metastatic disease 5. ECOG Performance Status of 0 to 1 6. Adequate organ function as defined by study-specified laboratory tests 7. Patients must be able to have fiducials placed for SBRT 8. Must use acceptable form of birth control through the study 9. Signed informed consent form 10. Willing and able to comply with study procedures Exclusion Criteria: 1. Patients who have been off of mFOLFIRINOX or gemcitabine/abraxane therapy for more than 49 days 2. Patients who have had more than one line of chemotherapy 3. Patients with uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements 4. Patient who have had prior treatment with IL-2, interferon, anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40, or anti-CTLA-4 antibodies 5. Patients receiving active immunosuppressive agents or chronic use of systemic corticosteroids within 14 days prior to first dose of study drug 6. Patients who have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 14 days of study drug administration 7. Patients with history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematous (SLE) autoimmune vasculitis, CNS or motor neuropathy considered to be of autoimmune origin. 8. Patients who have known history of infection with HIV, hepatitis B, or hepatitis C 9. Patients with evidence of interstitial lung disease 10. Patients on home oxygen 11. Patients with oxygen saturation of \<92% on room air by pulse oximetry 12. Pregnant or lactating 13. Conditions, including alcohol or drug dependence, or intercurrent illness that would affect the patient's ability to comply with study visits and procedures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
The Sidney Kimmel Comprehensive Cancer at Johns Hopkins
Baltimore, Maryland, 21231, United States
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