Trial · NCT02617589
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)
NCT02617589, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2021-02-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT02617589. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02617589
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 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)
- NCT number
- NCT02617589
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 560 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Brain Cancer
- Interventions
- Nivolumab, Temozolomide, Radiotherapy
- First posted
- 2015-12-01
- Last updated
- 2023-03-28
- Other registries' IDs
- eudract:2015-003739-37
- Results first posted
- 2021-02-03
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | up to 3 years | 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. |
| Secondary | Kaplan-Meier Plot of Progression Free Survival | From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) | PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria. |
| Secondary | Overall Survival Rate at 24 Months | At 24 Months | The overall survival (OS) rate of (nivolumab + radiation therapy) and (temozolomide + radiation therapy) estimated as Kaplan-Meier probability of survival at 24 months. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date. |
| Secondary | Overall Survival in Tumor Mutational Burden (TMB) High Population | From randomization to the date of death due to any cause (up to approximately 6 years) | OS in all randomized participants that are tumor mutational burden high. OS was defined as the time between the date of randomization and the date of death due to any cause. A participant who has not died was censored at the last known alive date. |
| Secondary | Progression Free Survival in Tumor Mutational Burden (TMB) High Population | From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) | PFS in all randomized participants that are tumor mutational burden high. PFS was defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Participants who did not have disease progression or who did not die were censored at the date of last tumor assessment. Participants who did not have any on study tumor assessment and did not have tumor progression or die were censored at the randomization date. Participants who started any subsequent anti-cancer therapy without a prior reported progression were censored at the last tumor assessment prior to initiation of the subsequent anti-cancer therapy. Participants who had surgical resection post start of study treatment were censored at the last tumor assessment date prior to initiation of surgical resection. PFS was determined by investigator reported response based on the Radiologic Assessment in Neuro-Oncology criteria. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) | up to 3 years | All Randomized Participants: All enrolled Participants who were randomized to any treatment arm. | Months | MEDIAN |
| SECONDARY | Kaplan-Meier Plot of Progression Free Survival | From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) | All Randomized Participants | Months | MEDIAN |
| SECONDARY | Overall Survival Rate at 24 Months | At 24 Months | All Randomized Participants | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival in Tumor Mutational Burden (TMB) High Population | From randomization to the date of death due to any cause (up to approximately 6 years) | Data was not and will never be collected | ||
| SECONDARY | Progression Free Survival in Tumor Mutational Burden (TMB) High Population | From randomization to the date of the first documented tumor progression or death due to any cause (up to approximately 6 years) | Data was not and will never be collected | ||
| POST_HOC | Kaplan-Meier Plot of Overall Survival (OS) - Extended Collection | From randomization to the date of death due to any cause (up to approximately 6 years) | All Randomized Participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) | Nivolumab + Radiation Therapy | 13.40 | 95% Confidence Interval 12.62 to 14.29 | Months | |
| Overall Survival (OS) | Temozolomide + Radiation Therapy | 14.88 | 95% Confidence Interval 13.27 to 16.13 | Months | |
| Kaplan-Meier Plot of Progression Free Survival | Nivolumab + Radiation Therapy | 6.01 | 95% Confidence Interval 5.65 to 6.21 | Months | |
| Kaplan-Meier Plot of Progression Free Survival | Temozolomide + Radiation Therapy | 6.21 | 95% Confidence Interval 5.98 to 6.90 | Months | |
| Overall Survival Rate at 24 Months | Nivolumab + Radiation Therapy | 10.6 | 95% Confidence Interval 7.3 to 14.6 | Percentage of participants | |
| Overall Survival Rate at 24 Months | Temozolomide + Radiation Therapy | 21.2 | 95% Confidence Interval 16.5 to 26.3 | Percentage of participants | |
| Kaplan-Meier Plot of Overall Survival (OS) - Extended Collection | Nivolumab + Radiation Therapy | 13.34 | 95% Confidence Interval 12.55 to 14.16 | Months | |
| Kaplan-Meier Plot of Overall Survival (OS) - Extended Collection | Temozolomide + Radiation Therapy | 14.92 | 95% Confidence Interval 13.27 to 16.10 | Months |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Nivolumab + Radiation Therapy | 280 | |
| Randomization | STARTED | Temozolomide + Radiation Therapy | 280 | |
| Randomization | COMPLETED | Nivolumab + Radiation Therapy | 278 | |
| Randomization | COMPLETED | Temozolomide + Radiation Therapy | 275 | |
| Randomization | NOT COMPLETED | Nivolumab + Radiation Therapy | 2 | |
| Randomization | NOT COMPLETED | Temozolomide + Radiation Therapy | 5 | |
| Treatment | STARTED | Nivolumab + Radiation Therapy | 278 | |
| Treatment | STARTED | Temozolomide + Radiation Therapy | 275 | |
| Treatment | COMPLETED | Nivolumab + Radiation Therapy | 0 | |
| Treatment | COMPLETED | Temozolomide + Radiation Therapy | 76 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events462
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 | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab + Radiation Therapy | 16 | 278 | |
| other | Anaemia | Blood and lymphatic system disorders | Temozolomide + Radiation Therapy | 11 | 275 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nivolumab + Radiation Therapy | 7 | 278 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Temozolomide + Radiation Therapy | 24 | 275 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivolumab + Radiation Therapy | 1 | 278 | |
| other | Neutropenia | Blood and lymphatic system disorders | Temozolomide + Radiation Therapy | 16 | 275 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivolumab + Radiation Therapy | 4 | 278 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Temozolomide + Radiation Therapy | 26 | 275 | |
| other | Hypothyroidism | Endocrine disorders | Nivolumab + Radiation Therapy | 18 | 278 | |
| other | Hypothyroidism | Endocrine disorders | Temozolomide + Radiation Therapy | 2 | 275 |
1 to 10 of 462Source ClinicalTrials.gov
See all 462 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab + Radiation Therapy | 269 | 280 |
| Total, all-cause mortality | Temozolomide + Radiation Therapy | 253 | 280 |
| Total, other adverse events | Nivolumab + Radiation Therapy | 262 | 278 |
| Total, other adverse events | Temozolomide + Radiation Therapy | 259 | 275 |
| Total, serious adverse events | Nivolumab + Radiation Therapy | 206 | 278 |
| Total, serious adverse events | Temozolomide + Radiation Therapy | 141 | 275 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 |
|---|---|
| Nivolumab + Radiation Therapy vs Temozolomide + Radiation Therapy: deaths from any cause | Trial comparisons |
| Nivolumab + Radiation Therapy vs Temozolomide + Radiation Therapy: 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.
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/NCT02617589
GET https://conductscience.org/api/trials/v1/NCT02617589/events?page=2