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NCT03161379 · ClinicalTrials.gov registry record · Phase 2
GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03161379: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03161379 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03161379, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study 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.
Primary Outcome
Mean CD8+ T cell density \[log(cells per mm\^2)\], found in resected surgical tissue by Immunohistochemistry (IHC).
Interventions
- DRUG Cyclophosphamide
- DRUG Nivolumab
- DRUG GVAX Pancreas Vaccine
- RADIATION Stereotactic Body Radiation (SBRT)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2018-02-02 |
| Est. Completion | 2024-02-28 |
| Phase | Phase 2 |
What the finished NCT03161379 record still lists
NCT03161379 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT03161379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03161379 about?
NCT03161379 is a clinical study titled "GVAX Pancreas Vaccine (With CY) in Combination With Nivolumab and SBRT for Patients With Borderline Resectable Pancreatic Cancer". 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.
What is the current status of trial NCT03161379?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2018-02-02. Estimated completion is 2024-02-28.
What interventions are being tested in trial NCT03161379?
The interventions under investigation include: Cyclophosphamide (DRUG), Nivolumab (DRUG), GVAX Pancreas Vaccine (DRUG), Stereotactic Body Radiation (SBRT) (RADIATION).
Who is sponsoring clinical trial NCT03161379?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03161379's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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