Trial · NCT02667587

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)

NCT02667587, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-02-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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). Trials, record NCT02667587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02667587

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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)
NCT number: NCT02667587
Status: Completed
Phases: Phase 3
Enrollment: 716 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Brain Neoplasms
Interventions: Nivolumab, Temozolomide, Radiotherapy, Nivolumab Placebo
First posted: 2016-01-29
Last updated: 2025-06-18
Other registries' IDs: eudract:2015-004722-34
Results first posted: 2022-02-03

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Progression-free Survival (PFS) Determined by BICR	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)	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 confirmation of progressive disease.
Primary	Overall Survival (OS)	From randomization to date of death (up to approximately 4.5 years)	The time from the date of randomization to the date of death. who have not died by the end of the study will be censored to last known date alive. OS is assessed in the randomized population with no corticosteroids at baseline population and in the overall randomized population.
Secondary	Overall Survival (OS) Rates at 12 Months	From randomization to 12 months after first dose	Overall Survival (OS) rate is defined as the percentage of participants surviving at 12 months
Secondary	Overall Survival (OS) Rates at 24 Months	From randomization to 24 months after first dose	Overall Survival (OS) rate is defined as the percentage of participants surviving at 24 months
Secondary	Progression Free Survival (PFS) Based on Investigator Assessment	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)	The time from randomization to the date of the first documented tumor progression or death by any cause. PFS will be determined by investigator assessment based 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 confirmation of progressive disease.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Progression-free Survival (PFS) Determined by BICR	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)	All randomized participants	Months	MEDIAN
PRIMARY	Overall Survival (OS)	From randomization to date of death (up to approximately 4.5 years)	All randomized participants	Months	MEDIAN
SECONDARY	Overall Survival (OS) Rates at 12 Months	From randomization to 12 months after first dose	All randomized participants	percentage of participants	NUMBER
SECONDARY	Overall Survival (OS) Rates at 24 Months	From randomization to 24 months after first dose	All randomized participants	percentage of participants	NUMBER
SECONDARY	Progression Free Survival (PFS) Based on Investigator Assessment	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 4.5 years)	All randomized participants	Months	MEDIAN
POST_HOC	Progression-free Survival (PFS) Determined by BICR - Extended Collection	From randomization to the date of the first documented tumor progression or death by any cause. (up to approximately 82 Months)	All randomized participants	Months	MEDIAN
POST_HOC	Overall Survival (OS) - Extended Collection	From randomization to date of death (up to approximately 82 Months)	All randomized participants with no baseline corticosteroids	Months	MEDIAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Progression-free Survival (PFS) Determined by BICR	Radiotherapy, Temozolomide Plus Nivolumab		10.64	95% Confidence Interval 8.90 to 11.79	Months
Progression-free Survival (PFS) Determined by BICR	Radiotherapy, Temozolomide Plus Placebo		10.32	95% Confidence Interval 9.69 to 12.45	Months
Overall Survival (OS)	Radiotherapy, Temozolomide Plus Nivolumab	All randomized participants	28.91	95% Confidence Interval 24.38 to 31.57	Months
Overall Survival (OS)	Radiotherapy, Temozolomide Plus Placebo	All randomized participants	32.07	95% Confidence Interval 29.37 to 33.77	Months
Overall Survival (OS)	Radiotherapy, Temozolomide Plus Nivolumab	All randomized participants without baseline corticosteroids	31.34	95% Confidence Interval 28.62 to 34.76	Months
Overall Survival (OS)	Radiotherapy, Temozolomide Plus Placebo	All randomized participants without baseline corticosteroids	32.99	95% Confidence Interval 31.01 to 35.09	Months
Overall Survival (OS) Rates at 12 Months	Radiotherapy, Temozolomide Plus Nivolumab		82.7	95% Confidence Interval 78.3 to 86.3	percentage of participants
Overall Survival (OS) Rates at 12 Months	Radiotherapy, Temozolomide Plus Placebo		87.7	95% Confidence Interval 83.8 to 90.8	percentage of participants
Overall Survival (OS) Rates at 24 Months	Radiotherapy, Temozolomide Plus Nivolumab		55.9	95% Confidence Interval 50.5 to 61.0	percentage of participants
Overall Survival (OS) Rates at 24 Months	Radiotherapy, Temozolomide Plus Placebo		63.3	95% Confidence Interval 58 to 68.2	percentage of participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment	STARTED	Radiotherapy, Temozolomide Plus Nivolumab	358
Pre-Treatment	STARTED	Radiotherapy, Temozolomide Plus Placebo	358
Pre-Treatment	COMPLETED	Radiotherapy, Temozolomide Plus Nivolumab	354
Pre-Treatment	COMPLETED	Radiotherapy, Temozolomide Plus Placebo	355
Pre-Treatment	NOT COMPLETED	Radiotherapy, Temozolomide Plus Nivolumab	4
Pre-Treatment	NOT COMPLETED	Radiotherapy, Temozolomide Plus Placebo	3
End of Treatment	STARTED	Radiotherapy, Temozolomide Plus Nivolumab	355
End of Treatment	STARTED	Radiotherapy, Temozolomide Plus Placebo	354
End of Treatment	COMPLETED	Radiotherapy, Temozolomide Plus Nivolumab	0
End of Treatment	COMPLETED	Radiotherapy, Temozolomide Plus Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events702

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Nivolumab	42	355
other	Anaemia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Placebo	26	354
other	Leukopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Nivolumab	20	355
other	Leukopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Placebo	30	354
other	Lymphopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Nivolumab	43	355
other	Lymphopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Placebo	39	354
other	Neutropenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Nivolumab	33	355
other	Neutropenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Placebo	32	354
other	Thrombocytopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Nivolumab	69	355
other	Thrombocytopenia	Blood and lymphatic system disorders	Radiotherapy, Temozolomide Plus Placebo	67	354

1 to 10 of 702Source ClinicalTrials.gov

See all 702 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Radiotherapy, Temozolomide Plus Nivolumab	263	358
Total, all-cause mortality	Radiotherapy, Temozolomide Plus Placebo	255	358
Total, other adverse events	Radiotherapy, Temozolomide Plus Nivolumab	351	355
Total, other adverse events	Radiotherapy, Temozolomide Plus Placebo	343	354
Total, serious adverse events	Radiotherapy, Temozolomide Plus Nivolumab	259	355
Total, serious adverse events	Radiotherapy, Temozolomide Plus Placebo	217	354

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32691060	DERIVED	PubMed
35511454	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: deaths from any cause	Trial comparisons
Radiotherapy, Temozolomide Plus Nivolumab vs Radiotherapy, Temozolomide Plus Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02667587

GET https://conductscience.org/api/trials/v1/NCT02667587/events?page=2

API reference For AI assistants