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NCT03190265 · ClinicalTrials.gov registry record · Phase 2
Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Completed
- Registry status
- Phase 2
- Development phase
- 61
- Enrollment target
NCT03190265: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
NCT03190265 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 61 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03190265, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 61 participants
- Enrollment target
Study Summary
The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
Primary Outcome
Objective Response Rate (ORR) is defined as the number of patients achieving a complete response (CR) or partial response (PR) based on RECIST 1.1 criteria. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions. Participants who discontinue due to toxicity or clinical progression prior to post-baseline tumor assessments will be considered as non-responders. Participants who discontinue for other reasons prior to their first dose of study drug will
Interventions
- DRUG Cyclophosphamide
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG CRS-207
- DRUG GVAX Pancreas Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 61 participants |
| Start Date | 2017-12-14 |
| Est. Completion | 2023-08-23 |
| Phase | Phase 2 |
What the finished NCT03190265 record still lists
NCT03190265 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 61 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (54% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT03190265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03190265 about?
NCT03190265 is a clinical study titled "Study of CRS-207, Nivolumab, and Ipilimumab With or Without GVAX Pancreas Vaccine (With Cy) in Patients With Pancreatic Cancer". The purpose of this study is to study the safety and clinical activity of nivolumab and ipilimumab in combination with either sequential administration of CY/GVAX pancreas vaccine followed by CRS-207 (Arm A) or with administration of CRS-207 alone (Arm B) in patients with pancreatic cancer.
What is the current status of trial NCT03190265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 61 participants. The study started on 2017-12-14. Estimated completion is 2023-08-23.
What interventions are being tested in trial NCT03190265?
The interventions under investigation include: Cyclophosphamide (DRUG), Nivolumab (DRUG), Ipilimumab (DRUG), CRS-207 (DRUG), GVAX Pancreas Vaccine (DRUG).
Who is sponsoring clinical trial NCT03190265?
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 NCT03190265's enrollment target sits among peer trials
61 1026th of 2000 higher than 974 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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