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NCT03130959 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 166
- Enrollment target
NCT03130959: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT03130959 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 166 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03130959, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 166 participants
- Enrollment target
Study Summary
The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.
Primary Outcome
A dose-limiting toxicity (DLT) is defined as a drug-related AE occurring in the first 6 weeks of study treatment. A participant was considered evaluable for a DLT if study treatment was delayed \> 2 weeks or was discontinued due to a related Adverse Event (AE), or if planned study treatment (3 doses of nivolumab in Module A, 2 doses of nivolumab plus ipilimumab in Module B) was administered and safety evaluation after 6 weeks on study is available to the study steering committee (SSC).
Interventions
- BIOLOGICAL Nivolumab
- BIOLOGICAL Ipilimumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2017-06-12 |
| Est. Completion | 2022-01-17 |
| Phase | Phase 2 |
What the finished NCT03130959 record still lists
NCT03130959 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT03130959 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03130959 about?
NCT03130959 is a clinical study titled "A Study to Evaluate the Safety and Efficacy of Nivolumab Monotherapy and Nivolumab in Combination With Ipilimumab in Pediatric Participants With High Grade Primary Central Nervous System (CNS) Malignancies". The purpose of this study is to determine the safety and effectiveness of nivolumab alone and in combination with ipilimumab in pediatric patients with high grade primary central nervous system (CNS) malignancies.
What is the current status of trial NCT03130959?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 166 participants. The study started on 2017-06-12. Estimated completion is 2022-01-17.
What interventions are being tested in trial NCT03130959?
The interventions under investigation include: Nivolumab (BIOLOGICAL), Ipilimumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT03130959?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03130959's enrollment target sits among peer trials
166 406th of 2000 higher than 1,591 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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