Trial · NCT03718767
Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
NCT03718767, Phase 2, Active not recruiting, National Cancer Institute (NCI); results first posted 2025-11-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype. Trials, record NCT03718767. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03718767
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Nivolumab in Patients With IDH-Mutant Gliomas With and Without Hypermutator Phenotype
- NCT number
- NCT03718767
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Glioma, Glioblastoma, High Grade Glioma, Low Grade Glioma, Malignant Glioma
- Interventions
- Nivolumab
- First posted
- 2018-10-24
- Last updated
- 2026-10-20
- Results first posted
- 2025-11-24
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Median Progression Free Survival (PFS) Rate at 6 Months | 6 months | PFS is defined from the day of study entry until imaging is confirmed to show disease progression or death, whichever occurs first. Disease progression was assessed by the Immunotherapy Response Assessment neuro-oncology Criteria. Disease progression is \>25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new enhancing measurable lesion that exceeds a 25% increase in cross-sectional area; clear clinical deterioration not attributable to other causes apart from the tumor and/or failure to return for evaluation due to death or deteriorating condition. PFS was analyzed by the Kaplan-Meier method and is reported with a 95% confidence interval. |
| Secondary | Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | Participant reported outcome measures using self-reported symptom interference with daily activities using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT). The MDSAI-BT 5-minute questionnaire uses an 11-point scale (0-10) to rate symptoms interference in the last 24 hours of a participant's life related to mood, work Inside and outside the home), relations with other people, walking and enjoyment of life. 0 = symptom not present and 10 = as bad as you can imagine. Higher score indicates more interference. Per protocol, MDSAIs are performed with imaging. If no imaging, no MDASI. |
| Secondary | Mean Symptom Severity Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | Participant reported outcome measures using self-reported symptom severity with daily activities (e.g., work) using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) are reported for each treatment cycle. The MDSAI-BT 5-minute questionnaire uses an 11-point Likert scale (0-10). 0 = symptom not present and 10 = as bad as you can imagine. Higher score indicates worse severity. Per protocol, MDSAIs are performed with imaging. If no imaging, no MDASI. |
| Secondary | Overall Survival | Until the death of the last surviving participant | OS is defined as the time from treatment initiation to the time of death. |
| Secondary | Tumor Mutation Burden | During the screening period (14 days prior to study therapy) | Tumor mutation Burden is measured using whole exome sequencing. |
| Secondary | Proportion of Participants Rating Symptoms 5 or Greater (on a 0-10 Scale) Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | The proportion of participants rating symptoms 5 or greater (on a 0-10 scale) was assessed using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT). The MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) 5-minute questionnaire uses an 11-point Likert scale (0-10) to measure symptoms reported by the participant. 0 = symptom not present and 10 = as bad as you can imagine. Higher score indicates worse severity. |
| Secondary | Median Percentage of Participants That Have Progressive Disease At 12 Months | At 12 months | PFS was analyzed by the Kaplan-Meier method and is reported with a 95% confidence interval. PFS is defined from the day of study entry until imaging is confirmed to show disease progression. Disease progression was assessed by the Immunotherapy Response Assessment neuro-oncology Criteria. Disease progression is \>25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new enhancing measurable lesion that exceeds a 25% increase in cross-sectional area; clear clinical deterioration not attributable to other causes apart from the tumor and/or failure to return for evaluation due to death or deteriorating condition. |
| Secondary | Number of Participants Responses Received and Were Expected Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Forms | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | Here is the number of participants with IDH-mutant gliomas with and without hypermutator phenotype, responses received and were expected using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) forms. Received MDASI-BT forms will be checked versus the timing schedule and considered as valid if they fall within ten days of the scheduled assessment window. Compliance rates will be calculated as the number of received valid forms over the number of expected forms. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | From the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to 17 months | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Median Progression Free Survival (PFS) Rate at 6 Months | 6 months | 38/62 participants are reported because 7 declined to participate (before treatment started) and 17 were ineligible. | Percentage of participants | NUMBER |
| SECONDARY | Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. Reasons data not reported in Cycles: participants came off treatment due to disease progression or toxicity, refused further treatment, did not complete the questionnaire, did extra MDASI because of short-interval imaging, refused to complete MDASI (no computer), data collected but not captured in database for a participant, and MDSAI not done related to outside hospitalization. | score on a scale | MEAN |
| SECONDARY | Mean Symptom Severity Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | score on a scale | MEAN |
| SECONDARY | Overall Survival | Until the death of the last surviving participant, a median of 7.4 months in Cohort 1 and a median of 31.6 months in Cohort 2. | 38/62 participants are reported because 7 declined to participate (before treatment started) and 17 were ineligible. | Months | MEDIAN |
| SECONDARY | Tumor Mutation Burden | During the screening period (14 days prior to study therapy) | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | mutation/Mb | MEAN |
| SECONDARY | Proportion of Participants Rating Symptoms 5 or Greater (on a 0-10 Scale) Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | proportion of participants | NUMBER |
| SECONDARY | Median Percentage of Participants That Have Progressive Disease At 12 Months | At 12 months | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants Responses Received and Were Expected Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) Forms | Baseline and Cycles 2, 4, 6, 8, 10, 12, 14, and 16 (approximately 32 weeks +/- 3 days). | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | From the first study intervention, Study Day 1 of Cycle 1 through 30 days after the study agent (s) was/were administered, up to 17 months | 38/62 participants were reported because 7 declined to participate (before treatment started) and 17 were ineligible. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group471
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Median Progression Free Survival (PFS) Rate at 6 Months | Cohort 1/Hypermutated Phenotype (HMP) | 25.0 | 95% Confidence Interval 7.5 to 83.0 | Percentage of participants | |
| Median Progression Free Survival (PFS) Rate at 6 Months | Cohort 2/Non-hypermutated Phenotype (NHMP). | 40.0 | 95% Confidence Interval 25.8 to 62.0 | Percentage of participants | |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 1/Hypermutated Phenotype (HMP) | Baseline | 3.96 | Standard Deviation 2.96 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 2/Non-hypermutated Phenotype (NHMP). | Baseline | 2.06 | Standard Deviation 2.80 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 1/Hypermutated Phenotype (HMP) | Cycle 2 | 3.21 | Standard Deviation 2.67 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 2/Non-hypermutated Phenotype (NHMP). | Cycle 2 | 2.30 | Standard Deviation 2.35 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 1/Hypermutated Phenotype (HMP) | Cycle 4 | 2.33 | Standard Deviation 1.99 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 2/Non-hypermutated Phenotype (NHMP). | Cycle 4 | 2.19 | Standard Deviation 2.07 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 1/Hypermutated Phenotype (HMP) | Cycle 6 | 2.42 | Standard Deviation 3.42 | score on a scale |
| Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) | Cohort 2/Non-hypermutated Phenotype (NHMP). | Cycle 6 | 2.41 | Standard Deviation 2.06 | score on a scale |
1 to 10 of 471Source ClinicalTrials.gov
See all 471 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1/Hypermutated Phenotype (HMP) | 8 | |
| Overall Study | STARTED | Cohort 2/Non-hypermutated Phenotype (NHMP). | 30 | |
| Overall Study | STARTED | Enrolled But Not Treated | 24 | |
| Overall Study | COMPLETED | Cohort 1/Hypermutated Phenotype (HMP) | 8 | |
| Overall Study | COMPLETED | Cohort 2/Non-hypermutated Phenotype (NHMP). | 30 | |
| Overall Study | COMPLETED | Enrolled But Not Treated | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1/Hypermutated Phenotype (HMP) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 2/Non-hypermutated Phenotype (NHMP). | 0 | |
| Overall Study | NOT COMPLETED | Enrolled But Not Treated | 24 |
Source ClinicalTrials.gov
Adverse events218
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 | Abducens nerve disorder | Nervous system disorders | Cohort 1/Hypermutated Phenotype (HMP) | 0 | 8 | 0 |
| other | Abducens nerve disorder | Nervous system disorders | Cohort 2/Non-hypermutated Phenotype (NHMP). | 1 | 30 | 1 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 1/Hypermutated Phenotype (HMP) | 0 | 8 | 0 |
| other | Adrenal insufficiency | Endocrine disorders | Cohort 2/Non-hypermutated Phenotype (NHMP). | 2 | 30 | 2 |
| other | Agitation | Psychiatric disorders | Cohort 1/Hypermutated Phenotype (HMP) | 0 | 8 | 0 |
| other | Agitation | Psychiatric disorders | Cohort 2/Non-hypermutated Phenotype (NHMP). | 1 | 30 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort 1/Hypermutated Phenotype (HMP) | 1 | 8 | 1 |
| other | Alanine aminotransferase increased | Investigations | Cohort 2/Non-hypermutated Phenotype (NHMP). | 1 | 30 | 2 |
| other | Alkaline phosphatase increased | Investigations | Cohort 1/Hypermutated Phenotype (HMP) | 0 | 8 | 0 |
| other | Alkaline phosphatase increased | Investigations | Cohort 2/Non-hypermutated Phenotype (NHMP). | 1 | 30 | 1 |
1 to 10 of 218Source ClinicalTrials.gov
See all 218 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1/Hypermutated Phenotype (HMP) | 6 | 8 |
| Total, all-cause mortality | Cohort 2/Non-hypermutated Phenotype (NHMP). | 16 | 30 |
| Total, other adverse events | Cohort 1/Hypermutated Phenotype (HMP) | 7 | 8 |
| Total, other adverse events | Cohort 2/Non-hypermutated Phenotype (NHMP). | 26 | 30 |
| Total, serious adverse events | Cohort 1/Hypermutated Phenotype (HMP) | 3 | 8 |
| Total, serious adverse events | Cohort 2/Non-hypermutated Phenotype (NHMP). | 11 | 30 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Cohort 1/Hypermutated Phenotype (HMP) vs Cohort 2/Non-hypermutated Phenotype (NHMP).: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Cohort 1/Hypermutated Phenotype (HMP) vs Cohort 2/Non-hypermutated Phenotype (NHMP).: deaths from any cause | Trial comparisons |
| Cohort 1/Hypermutated Phenotype (HMP) vs Cohort 2/Non-hypermutated Phenotype (NHMP).: 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/NCT03718767
GET https://conductscience.org/api/trials/v1/NCT03718767/results?page=2