Clinical trial · Interventional
Study With CY, Pembrolizumab, GVAX Pancreas Vaccine, and SBRT in Patients With Locally Advanced Pancreatic Cancer
A Phase II Study of GM-CSF Secreting Allogeneic Pancreatic Cancer Vaccine in Combination With PD-1 Blockade Antibody (Pembrolizumab) and Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Locally Advanced Adenocarcinoma of the Pancreas
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will be looking at whether combining cyclophosphamide, pembrolizumab (an antibody that blocks negative signals to T cells), GVAX (pancreatic cancer vaccine), and SBRT (focused radiation) is effective (anti-tumor activity) and safe in patients with locally advanced pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| GVAX Pancreatic Cancer Vaccine | Drug | — | UNRESOLVED |
| Pembrolizumab | Drug | Pembrolizumab | ALIAS |
| SBRT | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclophosphamide, Pembrolizumab, GVAX Pancreas Vaccine, SBRT
- interventionNames
- Drug: Cyclophosphamide
- Drug: GVAX Pancreatic Cancer Vaccine
- Drug: Pembrolizumab
- Radiation: SBRT
Primary outcomes (1)
- measure
- Distant Metastasis Free Survival (DMFS)
- timeFrame
- 62 months
- description
- DMFS is defined as the duration of time from start of treatment to identification of distant metastases on imaging or death, whichever occurs first. Estimation based on the Kaplan-Meier curve.
Secondary outcomes (1)
- measure
- Number of Participants Experiencing a Grade 3 or Above Treatment Related Toxicities
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available