Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02667587 · ClinicalTrials.gov registry record · Phase 3
An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, for Newly Diagnosed Patients With Glioblastoma (GBM, a Malignant Brain Cancer)
A Phase 3 study of Brain Neoplasms, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 716
- Enrollment target
- 20
- Study locations
NCT02667587: Completed Phase 3 study of Brain Neoplasms, sponsored by Bristol-Myers Squibb.
NCT02667587 is a Phase 3 study of Brain Neoplasms that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 716 participants, above the 205-participant average among 14 other Brain Neoplasms trials with a reported enrollment target (249% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02667587, a Phase 3 study of Brain Neoplasms, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 716 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate patients with glioblastoma that is MGMT-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation therapy.
Primary Outcome
The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by a Blinded Independent Central Review (BICR) assessed based on Radiologic Assessment in Neuro-Oncology (RANO) criteria. Specifically, RANO response criteria indicates that within the first 12 weeks of completion of radiotherapy, progression can only be assessed if the majority of the new enhancement is outside of the radiation field or if there is pathologic confirmat
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Temozolomide
- RADIATION Radiotherapy
- OTHER Nivolumab Placebo
Study Locations (20)
California
- Cedars Sinai Medical Center - Los Angeles
- Local Institution - 0010 - Los Angeles
- Local Institution - 0128 - Sacramento
- Local Institution - 0029 - San Diego
- Local Institution - 0006 - San Francisco
Florida
- Local Institution - 0087 - Miami
- Local Institution - 0030 - Tampa
Massachusetts
- Local Institution - 0011 - Boston
- Local Institution - 0028 - Boston
Alabama
- Local Institution - 0023 - Birmingham
Arizona
- Local Institution - 0003 - Phoenix
Connecticut
- Local Institution - 0004 - New Haven
District of Columbia
- Local Institution - 0031 - Washington D.C.
Illinois
- Local Institution - 0022 - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 716 participants |
| Start Date | 2016-05-09 |
| Est. Completion | 2024-04-09 |
| Phase | Phase 3 |
What the finished NCT02667587 record still lists
NCT02667587 is an interventional study that assigns participants to a tested intervention. The registered 716 participants enrollment target is mid-sized for trials with a published cap, above the 205-participant average among 14 other Brain Neoplasms trials with a reported enrollment target (249% higher).
The record links to 1 condition, with Brain Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Nivolumab is the first listed.
NCT02667587 names 20 study sites across 14 states, led by California, Florida, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02667587 about?
NCT02667587 is a clinical study titled "An Investigational Immuno-therapy Study of Temozolomide Plus Radiation Therapy With Nivolumab or Placebo, 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-methylated (the MGMT gene is altered by a chemical change). Patients will receive temozolomide plus radiation therapy. They will be compared to patients receiving nivolumab in addition to temozolomide plus radiation the...
What is the current status of trial NCT02667587?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 716 participants. The study started on 2016-05-09. Estimated completion is 2024-04-09.
What conditions does trial NCT02667587 study?
This clinical trial studies the following conditions: Brain Neoplasms.
What interventions are being tested in trial NCT02667587?
The interventions under investigation include: Nivolumab (DRUG), Temozolomide (DRUG), Radiotherapy (RADIATION), Nivolumab Placebo (OTHER).
Who is sponsoring clinical trial NCT02667587?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02667587 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02667587's enrollment target sits among peer trials
716 2nd of 14 the highest of 14 other Brain Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Neoplasms 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
-
Study of Neurologic Progression With Motexafin Gadolinium and Radiation Therapy (SMART)
COMPLETED · Phase 3
-
The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201)
RECRUITING
-
A Study to Learn About the Study Medicine Called PF-07799544 as Monotherapy or in Combination in People With Advanced Solid Tumors
RECRUITING · Phase 1
-
Guided Meditation During Radiation Therapy for Brain Tumors
RECRUITING · NA
-
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
RECRUITING · Phase 1
-
The RECMAP-study: Resection With or Without Intraoperative Mapping for Recurrent Glioblastoma
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04680000 · 716 participants · NA
Chronic Pain Management In Primary Care Using Behavioral Health Consultants
- NCT05208762 · 714 participants · Phase 1
A Study of PF-08046054/SGN-PDL1V in Advanced Solid Tumors
- NCT06758401 · 714 participants · Phase 3
This is a Study to Learn About How the Combination of the Study Medicines Sigvotatug Vedotin Plus Pembrolizumab Works in People With Non-small Cell Lung Cancer With High Levels of PD-L1.
- NCT04916327 · 720 participants · NA
Examining the Impact of Exercise Training on Vascular Dysfunction in Individuals With Mental Health Disorders - Study 1
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI