Clinical trialPhase 2Completed
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
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 2 February 2018
- Expected end
- 28 February 2024
- Enrollment
- 31 participants
- Sites
- 2
- Primary outcomes
- CD8+ T Cell Density in Tumor Tissue
- Sponsor
- Other
- Results posted
- 2025-02-03
- Last update
- 3 February 2025
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Brief summary public domain (ClinicalTrials.gov)
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.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
CD8+ T Cell Density in Tumor Tissue [evaluated at time of surgery, approximately 2 months from first dose of study drug]. Mean, log (cells per mm^2) (Standard Deviation). CY, Nivolumab, GVAX, and SBRT (n=13): 5.4 (0.8).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Pathologic Complete Response (pCR) Rate at Surgical Resection [Assessed at time of surgical resection, approximately 2 months after first dose of study drug]. Count Of Participants, Participants. CY, Nivolumab, GVAX, and SBRT (n=14): 1.