Trial · NCT03130959
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
NCT03130959, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2021-04-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT03130959. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03130959
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03130959
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 166 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Various Advanced Cancer
- Interventions
- Nivolumab, Ipilimumab
- First posted
- 2017-04-27
- Last updated
- 2022-08-09
- Other registries' IDs
- eudract:2016-004441-82
- Results first posted
- 2021-04-01
Source ClinicalTrials.gov
Registered outcomes17
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | up to 6 weeks post-dosing | 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). |
| Primary | Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | up to 6 weeks post-dosing | The number of Safety Lead-In Participants who experienced a Serious Adverse Event (SAE) during the course of the study. |
| Primary | Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 30 days post-last dose (up to approximately 6 weeks) | The number of Safety Lead-In Participants who experienced an Adverse Event (AE) during the course of the study that lead to discontinuation of study therapy. |
| Primary | Overall Survival (OS), Cohort 1 Only | up to approximately 42 months | Overall survival (OS) is defined as the time between the date of diagnosis and the date of death in Cohort 1. |
| Primary | Progression-Free Survival (PFS), Cohorts 2-4 | up to approximately 42 months | Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. |
| Primary | Progression-Free Survival (PFS), Cohort 5 Only | up to approximately 42 months | Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. |
| Secondary | Progression-Free Survival (PFS), Cohort 1 Only | From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months) | Progression-free survival (PFS) is defined as the time from first dose to the date of the first documented tumor progression or death due to any cause. Progression is defined as: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement * Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor * Failure to return for evaluation as a result of death or deteriorating condition * Clear progression of non-measurable disease |
| Secondary | Overall Survival at 12 Months (OS12), Cohorts 1-4 | From first dose to up to 12 months after first dose | Overall survival at 12 months (OS12) is defined as the percentage of participants who are alive at 12 months, measured as the survival rate at 12 months from Kaplan-Meier product limit cumulative probability. |
| Secondary | Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5 | From first dose to up to 6 months after first dose | Progression-free survival at 6 months (PFS6) is defined as the percentage of participants who are progression free and alive at 6 months following first dose date, measured as the survival rate at 6 months from Kaplan-Meier product limit cumulative probability of progression free. Progression is defined as: * ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement * Significant increase in T2 or fast fluid-attenuated inversion recovery (FLAIR) non-enhancing lesions on stable or increasing doses of corticosteroids * Any new lesion * Clear clinical deterioration not attributable to other causes apart from the tumor * Failure to return for evaluation as a result of death or deteriorating condition * Clear progression of non-measurable disease |
| Secondary | Overall Survival (OS), Cohorts 2-5 | From first dose to the date of death (up to approximately 55 months) | Overall survival (OS) is defined as the time between date of first dose and the date of death for Cohorts 2-5. |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 registered outcomesOutcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | up to 6 weeks post-dosing | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Number of participants | NUMBER |
| PRIMARY | Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | up to 6 weeks post-dosing | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Number of participants | NUMBER |
| PRIMARY | Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | From first dose to 30 days post-last dose (up to approximately 6 weeks) | Safety Lead-in participants: In Module A, the first 6 DLT-evaluable participants in Cohort 1 and the first 10 DLT-evaluable participants in Cohorts 2-5; in Module B, the first 10 DLT-evaluable participants. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Overall Survival (OS), Cohort 1 Only | up to approximately 42 months | All treated participants | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS), Cohorts 2-4 | up to approximately 42 months | All treated participants | months | MEDIAN |
| PRIMARY | Progression-Free Survival (PFS), Cohort 5 Only | up to approximately 42 months | All treated participants | months | MEDIAN |
| SECONDARY | Progression-Free Survival (PFS), Cohort 1 Only | From first dose to the date of the first documented tumor progression or death due to any cause (up to approximately 55 months) | All treated participants in Cohort 1 | Months | MEDIAN |
| SECONDARY | Overall Survival at 12 Months (OS12), Cohorts 1-4 | From first dose to up to 12 months after first dose | All treated participants in Cohorts 1-4 | Percentage of participants | NUMBER |
| SECONDARY | Progression-Free Survival at 6 Months (PFS6), Cohorts 2-5 | From first dose to up to 6 months after first dose | All treated participants in Cohorts 2-5 | Percentage of participants | NUMBER |
| SECONDARY | Overall Survival (OS), Cohorts 2-5 | From first dose to the date of death (up to approximately 55 months) | All treated participants in Cohorts 2-5 | Months | MEDIAN |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 outcomesResults by group300
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | Arm A1, Safety Lead-in | 0 | Number of participants | ||
| Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | Arms A2-A5, Safety Lead-in | 0 | Number of participants | ||
| Number of Safety Lead-In Participants With Dose Limiting Toxicities (DLTs) | Arms B2-B5, Safety Lead-in | 0 | Number of participants | ||
| Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | Arm A1, Safety Lead-in | 7 | Number of participants | ||
| Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | Arms A2-A5, Safety Lead-in | 6 | Number of participants | ||
| Number of Safety Lead-In Participants With Serious Adverse Events (SAEs) | Arms B2-B5, Safety Lead-in | 8 | Number of participants | ||
| Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | Arm A1, Safety Lead-in | 3 | Participants | ||
| Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | Arms A2-A5, Safety Lead-in | 4 | Participants | ||
| Number of Safety Lead-In Participants With Adverse Events (AEs) Leading to Discontinuation | Arms B2-B5, Safety Lead-in | 2 | Participants | ||
| Overall Survival (OS), Cohort 1 Only | Arm A1 | 11.66 | 80% Confidence Interval 10.32 to 16.46 | months |
1 to 10 of 300Source ClinicalTrials.gov
See all 300 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Arm A1 | 23 | |
| Overall Study | STARTED | Arm B1 | 22 | |
| Overall Study | STARTED | Arm A2 | 16 | |
| Overall Study | STARTED | Arm B2 | 15 | |
| Overall Study | STARTED | Arm A3 | 15 | |
| Overall Study | STARTED | Arm B3 | 15 | |
| Overall Study | STARTED | Arm A4 | 12 | |
| Overall Study | STARTED | Arm B4 | 10 | |
| Overall Study | STARTED | Arm A5 | 19 | |
| Overall Study | STARTED | Arm B5 | 19 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events4,640
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 | Arm A1 | 1 | 23 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B1 | 1 | 22 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A2 | 2 | 16 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B2 | 3 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A3 | 3 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B3 | 3 | 15 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A4 | 2 | 12 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B4 | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm A5 | 5 | 19 | |
| other | Anaemia | Blood and lymphatic system disorders | Arm B5 | 1 | 19 |
1 to 10 of 4,640Source ClinicalTrials.gov
See all 4,640 adverse eventsAdverse event totals30
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm A1 | 18 | 23 |
| Total, all-cause mortality | Arm B1 | 18 | 22 |
| Total, all-cause mortality | Arm A2 | 12 | 16 |
| Total, all-cause mortality | Arm B2 | 13 | 15 |
| Total, all-cause mortality | Arm A3 | 12 | 15 |
| Total, all-cause mortality | Arm B3 | 11 | 15 |
| Total, all-cause mortality | Arm A4 | 9 | 12 |
| Total, all-cause mortality | Arm B4 | 7 | 10 |
| Total, all-cause mortality | Arm A5 | 18 | 19 |
| Total, all-cause mortality | Arm B5 | 15 | 19 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36808285 | DERIVED |
Source 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT03130959
GET https://conductscience.org/api/trials/v1/NCT03130959/results?page=2