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NCT02617589 · ClinicalTrials.gov registry record · Phase 3
An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 560
- Enrollment target
NCT02617589: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT02617589 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 560 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02617589, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 560 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving standard therapy with temozolomide in addition to radiation therapy.
Primary Outcome
OS is defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died will be censored at the last known alive date.
Interventions
- DRUG Nivolumab
- DRUG Temozolomide
- RADIATION Radiotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 560 participants |
| Start Date | 2016-03-01 |
| Est. Completion | 2022-03-04 |
| Phase | Phase 3 |
What the finished NCT02617589 record still lists
NCT02617589 is an interventional study that assigns participants to a tested intervention. The registered 560 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Nivolumab is the first listed.
NCT02617589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02617589 about?
NCT02617589 is a clinical study titled "An Investigational Immuno-therapy Study of Nivolumab Compared to Temozolomide, Each Given With Radiation Therapy, for Newly-diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)". The purpose of this study is to evaluate patients with glioblastoma that is MGMT-unmethylated (the MGMT gene is not altered by a chemical change). Patients will receive Nivolumab every two weeks in addition to radiation therapy, and then every four weeks. They will be compared to patients receiving ...
What is the current status of trial NCT02617589?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 560 participants. The study started on 2016-03-01. Estimated completion is 2022-03-04.
What interventions are being tested in trial NCT02617589?
The interventions under investigation include: Nivolumab (DRUG), Temozolomide (DRUG), Radiotherapy (RADIATION).
Who is sponsoring clinical trial NCT02617589?
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 NCT02617589's enrollment target sits among peer trials
560 671st of 2000 higher than 1,328 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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