18 and older, any sex, with Glioma or Glioblastoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Median Progression Free Survival (PFS) Rate at 6 MonthsPrimary· 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 wa
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
25.0
7.5 – 83.0
Cohort 2/Non-hypermutated Phenotype (NHMP).
40.0
25.8 – 62.0
Mean Symptom Interference Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT)Secondary· 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.
Baseline
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
3.96
± 2.96
Cohort 2/Non-hypermutated Phenotype (NHMP).
2.06
± 2.80
Cycle 2
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
3.21
± 2.67
Cohort 2/Non-hypermutated Phenotype (NHMP).
2.30
± 2.35
Cycle 4
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.33
± 1.99
Cohort 2/Non-hypermutated Phenotype (NHMP).
2.19
± 2.07
Cycle 6
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.42
± 3.42
Cohort 2/Non-hypermutated Phenotype (NHMP).
2.41
± 2.06
Cycle 8
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
3.00
± 4.00
Cohort 2/Non-hypermutated Phenotype (NHMP).
2.46
± 2.03
Cycle 10
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
4.17
± 5.42
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.45
± 1.43
Cycle 12
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
4.25
± 6.01
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.00
± 1.28
Cycle 14
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
4.83
± 6.36
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.17
± 1.59
Mean Symptom Severity Score Per Treatment Cycle Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT)Secondary· 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.
Baseline
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
3.16
± 2.78
Cohort 2/Non-hypermutated Phenotype (NHMP).
4.16
± 1.56
Cycle 2
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.16
± 1.77
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.48
± 1.29
Cycle 4
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
1.61
± 1.31
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.50
± 1.23
Cycle 6
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.00
± 2.57
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.26
± 1.12
Cycle 8
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
1.91
± 2.57
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.20
± 1.25
Cycle 10
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.07
± 2.80
Cohort 2/Non-hypermutated Phenotype (NHMP).
0.82
± 0.70
Cycle 12
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.70
± 3.70
Cohort 2/Non-hypermutated Phenotype (NHMP).
0.97
± 0.97
Cycle 14
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2.41
± 3.34
Cohort 2/Non-hypermutated Phenotype (NHMP).
0.74
± 0.51
Overall SurvivalSecondary· 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.
OS is defined as the time from treatment initiation to the time of death.
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
7.4
4.7 – NA
Cohort 2/Non-hypermutated Phenotype (NHMP).
31.6
10.2 – NA
Tumor Mutation BurdenSecondary· During the screening period (14 days prior to study therapy)
Tumor mutation Burden is measured using whole exome sequencing.
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
76.39
± 78.54
Cohort 2/Non-hypermutated Phenotype (NHMP).
1.28
± 0.61
Proportion of Participants Rating Symptoms 5 or Greater (on a 0-10 Scale) Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT)Secondary· 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.
Median Percentage of Participants That Have Progressive Disease At 12 MonthsSecondary· 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
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
25.0
7.5 – 83.0
Cohort 2/Non-hypermutated Phenotype (NHMP).
33.3
20.1 – 55.3
Number of Participants Responses Received and Were Expected Using the MD Anderson Symptom Inventory-Brain Tumor Module (MDSAI-BT) FormsSecondary· 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.
Expected at baseline
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
8
Cohort 2/Non-hypermutated Phenotype (NHMP)
30
Received at baseline
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
8
Cohort 2/Non-hypermutated Phenotype (NHMP)
30
Expected at Cycle 2
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
7
Cohort 2/Non-hypermutated Phenotype (NHMP)
27
Received at Cycle 2
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
7
Cohort 2/Non-hypermutated Phenotype (NHMP)
25
Expected at Cycle 4
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
4
Cohort 2/Non-hypermutated Phenotype (NHMP)
16
Received at Cycle 4
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
4
Cohort 2/Non-hypermutated Phenotype (NHMP)
15
Expected at Cycle 6
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2
Cohort 2/Non-hypermutated Phenotype (NHMP)
11
Received at Cycle 6
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
2
Cohort 2/Non-hypermutated Phenotype (NHMP)
9
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)Secondary· 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
Group
Value
95% CI
Cohort 1/Hypermutated Phenotype (HMP)
7
Cohort 2/Non-hypermutated Phenotype (NHMP).
26
Adverse events — posted to ClinicalTrials.gov
Time frame: All-Cause Mortality was monitored/assessed up to a median of 7.4 months in cohort 1 and a median of 31.6 months in cohort 2. Adverse Events (AEs) were only collected from beginning of study participation to one month post study participation, a maximum of 17 months..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Background:
Gliomas are the most common malignant brain tumors. Some have certain changes (mutations) in the genes isocitrate dehydrogenase 1 (IDH1) or isocitrate dehydrogenase 2 (IDH2). If there are a high number of mutations in a tumor, it is called hypermutator phenotype (HMP). The drug nivolumab helps the immune system fight cancer. Researchers think it can be more effective in patients with IDH1 or IDH2 mutated gliomas with HMP. They will test gliomas with and without HMP.
Objectives:
To see if nivolumab stops tumor growth and prolongs the time that the tumor is controlled.
Eligibility:
Adults 18 years or older with IDH1 or IDH2 mutated gliomas
Design:
Participants will be screened with:
Medical history
Physical exam
Heart, blood, and pregnancy tests
Review of symptoms and activity levels
Brain magnetic resonance imaging (MRI). Participants will lie in a cylinder that takes pictures in a strong magnetic field.
Tumor samples
Participants will get the study drug in 4-week cycles. They will get it through a small plastic tube in a vein (intravenous \[IV\]) on days 1 and 15 of cycles 1-4. For cycles 5-16, they will get it just on day 1.
On days 1 and 15 of each cycle, participants will repeat some or all screening tests.
After cycle 16, participants will have 3 follow-up visits over 100 days. They will answer health questions, have physical and neurological exams, and have blood tests. They may have a brain MRI.
Participants whose disease did not get worse but who finished the study drug within 1 year of treatment may have imaging studies every 8 weeks for up to 1 year.
Participants will be called or emailed every 6 months with questions about their health.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
· not yet recruiting
NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A
· Phase 1
· not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
· Phase 3
· not yet recruiting
NCT07420439 — Treatment in Patients With Advanced Non-Small Cell Lung Carcinoma and Interstitial Lung Disease
· Phase 2
· not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma
· Phase 2
· not yet recruiting
Other recruiting trials for Glioma
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NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem
· Phase 2, PHASE3
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NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 24 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03718767.