Trial · NCT02052648

Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors

NCT02052648, Phase 1, Phase 2, Completed, NewLink Genetics Corporation; results first posted 2024-03-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors. Trials, record NCT02052648. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02052648

On this page

Trial

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

Title: Study of IDO Inhibitor and Temozolomide for Adult Patients With Primary Malignant Brain Tumors
NCT number: NCT02052648
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 160 participants, actual
Lead sponsor: NewLink Genetics Corporation
Conditions: Glioblastoma Multiforme, Glioma, Gliosarcoma, Malignant Brain Tumor
Interventions: Indoximod, Temozolomide, Bevacizumab, Stereotactic Radiation
First posted: 2014-02-03
Last updated: 2024-03-27
Results first posted: 2024-03-27

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	3 months	Number of RLTs observed in each dose level.
Primary	Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	6 months	Six-month progression-free survival.
Secondary	Overall Response Rate for Phase 2 Participants	18 months	Subjects with a complete response or partial response by RANO assessment. Overall Response Rate was only assessed in phase 2 subjects on this trial.
Secondary	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	18 Months	Number of subjects with at least 1 treatment emergent adverse event.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	3 months	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	6 months	Percent	NUMBER
SECONDARY	Overall Response Rate for Phase 2 Participants	18 months	Percent	NUMBER
SECONDARY	Number of Participants With Adverse Events as a Measure of Safety and Tolerability	18 Months	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group15

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

Outcome	Group	Value	Spread	Units
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	Phase 1 Dose Level 1	0		Participants
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	Phase 1 Dose Level 2	0		Participants
Frequency of Regimen-Limiting Toxicities (RLTs) in Phase 1 Subjects	Phase 1 Dose Level 3	0		Participants
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	Phase 2 Cohort 2a	18.6	95% Confidence Interval 10.4 to 28.8	Percent
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	Phase 2 Cohort 2b	3.9	95% Confidence Interval 0.3 to 16.6	Percent
Phase 2: Number of Phase 1 Participants With Efficacy Outcomes	Phase 2 Cohort 2c	22.9	95% Confidence Interval 10.5 to 38.3	Percent
Overall Response Rate for Phase 2 Participants	Phase 2 Cohort 2a	5.2	95% Confidence Interval 1.4 to 12.8	Percent
Overall Response Rate for Phase 2 Participants	Phase 2 Cohort 2b	0	95% Confidence Interval 0 to 12.3	Percent
Overall Response Rate for Phase 2 Participants	Phase 2 Cohort 2c	7.7	95% Confidence Interval 1.6 to 20.9	Percent
Number of Participants With Adverse Events as a Measure of Safety and Tolerability	Phase 1 Dose Level 1	3		Participants

1 to 10 of 15Source ClinicalTrials.gov

See all 15 results by group

Participant flow18

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Phase 1 Dose Level 1	3
Overall Study	STARTED	Phase 1 Dose Level 2	3
Overall Study	STARTED	Phase 1 Dose Level 3	6
Overall Study	STARTED	Phase 2 Cohort 2a	80
Overall Study	STARTED	Phase 2 Cohort 2b	28
Overall Study	STARTED	Phase 2 Cohort 2c	40
Overall Study	COMPLETED	Phase 1 Dose Level 1	3
Overall Study	COMPLETED	Phase 1 Dose Level 2	3
Overall Study	COMPLETED	Phase 1 Dose Level 3	6
Overall Study	COMPLETED	Phase 2 Cohort 2a	80

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2,004

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	Headache	Nervous system disorders	Phase 1 Dose Level 1	0	3	0
other	Headache	Nervous system disorders	Phase 1 Dose Level 2	2	3	2
other	Headache	Nervous system disorders	Phase 1 Dose Level 3	4	6	4
other	Headache	Nervous system disorders	Phase 2 Cohort 2a	22	77	22
other	Headache	Nervous system disorders	Phase 2 Cohort 2b	7	28	7
other	Headache	Nervous system disorders	Phase 2 Cohort 2c	19	39	19
other	Dizziness	Nervous system disorders	Phase 1 Dose Level 1	0	3	0
other	Dizziness	Nervous system disorders	Phase 1 Dose Level 2	2	3	2
other	Dizziness	Nervous system disorders	Phase 1 Dose Level 3	2	6	2
other	Dizziness	Nervous system disorders	Phase 2 Cohort 2a	13	77	13

1 to 10 of 2,004Source ClinicalTrials.gov

See all 2,004 adverse events

Adverse event totals18

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Phase 1 Dose Level 1	3	3
Total, all-cause mortality	Phase 1 Dose Level 2	3	3
Total, all-cause mortality	Phase 1 Dose Level 3	6	6
Total, all-cause mortality	Phase 2 Cohort 2a	67	77
Total, all-cause mortality	Phase 2 Cohort 2b	28	28
Total, all-cause mortality	Phase 2 Cohort 2c	34	39
Total, other adverse events	Phase 1 Dose Level 1	3	3
Total, other adverse events	Phase 1 Dose Level 2	3	3
Total, other adverse events	Phase 1 Dose Level 3	6	6
Total, other adverse events	Phase 2 Cohort 2a	77	77

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse event totals

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 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.

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/NCT02052648

GET https://conductscience.org/api/trials/v1/NCT02052648/events?page=2

API reference For AI assistants