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NCT03404960 · ClinicalTrials.gov registry record · Phase 1
Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy
A Phase 1 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 1
- Development phase
- 104
- Enrollment target
NCT03404960: Completed Phase 1 study, sponsored by University of Pennsylvania.
NCT03404960 is a Phase 1 study that has completed, run by University of Pennsylvania. The registered enrollment target is 104 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03404960, a Phase 1 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 104 participants
- Enrollment target
Study Summary
The main purpose of this study is to look at the effectiveness, safety, and anti-tumor activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or Nivolumab on patients and their pancreatic cancer.
Primary Outcome
The PFS6 rate will be estimated using the Kaplan-Meier method, and the 95% confidence interval will be estimated from the Kaplan-Meier curve. The null hypothesis is that the PFS6 rate in this population of subjects is 44%. Progressive disease is defined as at least a 20% increase in the sum of all the longest diameter (LD) of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20
Interventions
- DRUG Niraparib + Nivolumab
- DRUG Niraparib + Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2018-01-31 |
| Est. Completion | 2024-10-09 |
| Phase | Phase 1 |
What the finished NCT03404960 record still lists
NCT03404960 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% higher).
The record links to 0 conditions, and to 2 interventions - of which Niraparib + Nivolumab is the first listed.
NCT03404960 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03404960 about?
NCT03404960 is a clinical study titled "Niraparib + Ipilimumab or Nivolumab in Progression Free Pancreatic Adenocarcinoma After Platinum-Based Chemotherapy". The main purpose of this study is to look at the effectiveness, safety, and anti-tumor activity (preventing growth of the tumor) of the drugs Niraparib with either Ipilimumab or Nivolumab on patients and their pancreatic cancer.
What is the current status of trial NCT03404960?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 104 participants. The study started on 2018-01-31. Estimated completion is 2024-10-09.
What interventions are being tested in trial NCT03404960?
The interventions under investigation include: Niraparib + Nivolumab (DRUG), Niraparib + Ipilimumab (DRUG).
Who is sponsoring clinical trial NCT03404960?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03404960's enrollment target sits among peer trials
104 536th of 2000 higher than 1,460 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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