Trial · NCT03557359

Nivolumab for Recurrent or Progressive IDH Mutant Gliomas

NCT03557359, Phase 2, Completed, Fabio Iwamoto, MD; results first posted 2025-11-03

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nivolumab for Recurrent or Progressive IDH Mutant Gliomas. Trials, record NCT03557359. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03557359

On this page

Trial

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

Title: Nivolumab for Recurrent or Progressive IDH Mutant Gliomas
NCT number: NCT03557359
Status: Completed
Phases: Phase 2
Enrollment: 35 participants, actual
Lead sponsor: Fabio Iwamoto, MD
Conditions: Gliomas
Interventions: Nivolumab
First posted: 2018-06-15
Last updated: 2026-06-10
Results first posted: 2025-11-03

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Overall Response Rate	Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 years	The overall response rate is defined as the percentage of patients with a reduction in tumor size while on treatment.
Secondary	Duration of Response	Until the first date that progressive disease is objectively documented or until study completion, up to 54 months	The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started).
Secondary	Progression-Free Survival (PFS)	Until death or study completion, up to 54 months	PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Participants discontinuing study treatment will remain on study for documentation of progression and death.
Secondary	Overall Survival (OS)	Until death or study completion, up to 54 months	OS is defined as the time from the first dose of nivolumab to death due to any cause. All other participants will be censored at the last date known to be alive.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Overall Response Rate	Throughout treatment duration or until progressive disease, unacceptable toxicity, or withdrawal of consent, up to 2 years	percent	NUMBER
SECONDARY	Duration of Response	Until the first date that progressive disease is objectively documented or until study completion (36 months)
SECONDARY	Progression-Free Survival (PFS)	Until death or study completion (36 months)
SECONDARY	Overall Survival (OS)	Until death or study completion (36 months)

Source ClinicalTrials.gov

Results by group1

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

Outcome	Group	Category	Value	Spread	Units
Overall Response Rate	Nivolumab		9		percent

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Dose 1: 240 mg	STARTED	Nivolumab 240 mg	33
Dose 1: 240 mg	STARTED	Nivolumab 480 mg	0
Dose 1: 240 mg	COMPLETED	Nivolumab 240 mg	32
Dose 1: 240 mg	COMPLETED	Nivolumab 480 mg	0
Dose 1: 240 mg	NOT COMPLETED	Nivolumab 240 mg	1
Dose 1: 240 mg	NOT COMPLETED	Nivolumab 480 mg	0
Dose 2: 480 mg	STARTED	Nivolumab 240 mg	0
Dose 2: 480 mg	STARTED	Nivolumab 480 mg	13
Dose 2: 480 mg	COMPLETED	Nivolumab 240 mg	0
Dose 2: 480 mg	COMPLETED	Nivolumab 480 mg	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events240

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	Abdominal Pain	Gastrointestinal disorders	Nivolumab 240 mg	2	33
other	Abdominal Pain	Gastrointestinal disorders	Nivolumab 480 mg	1	13
other	Agitation	Psychiatric disorders	Nivolumab 240 mg	1	33
other	Agitation	Psychiatric disorders	Nivolumab 480 mg	0	13
other	Alanine aminotransferase increased	Investigations	Nivolumab 240 mg	7	33
other	Alanine aminotransferase increased	Investigations	Nivolumab 480 mg	2	13
other	Alkaline phosphatase increased	Investigations	Nivolumab 240 mg	0	33
other	Alkaline phosphatase increased	Investigations	Nivolumab 480 mg	1	13
other	Allergic reaction	Immune system disorders	Nivolumab 240 mg	2	33
other	Allergic reaction	Immune system disorders	Nivolumab 480 mg	0	13

1 to 10 of 240Source ClinicalTrials.gov

See all 240 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab 240 mg	0	33
Total, all-cause mortality	Nivolumab 480 mg	0	13
Total, other adverse events	Nivolumab 240 mg	29	33
Total, other adverse events	Nivolumab 480 mg	13	13
Total, serious adverse events	Nivolumab 240 mg	9	33
Total, serious adverse events	Nivolumab 480 mg	4	13

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
17404084	BACKGROUND	PubMed
19228619	BACKGROUND	PubMed
25219814	BACKGROUND	PubMed
25409260	BACKGROUND	PubMed
25765070	BACKGROUND	PubMed
26404381	BACKGROUND	PubMed
26439694	BACKGROUND	PubMed
26952546	BACKGROUND	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
Nivolumab 240 mg vs Nivolumab 480 mg: deaths from any cause	Trial comparisons
Nivolumab 240 mg vs Nivolumab 480 mg: 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/NCT03557359

GET https://conductscience.org/api/trials/v1/NCT03557359/events?page=2

API reference For AI assistants