Trial · NCT04164901
Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
NCT04164901, Phase 3, Active not recruiting, Institut de Recherches Internationales Servier; results first posted 2023-11-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO). Trials, record NCT04164901. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04164901
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Vorasidenib (AG-881) in Participants With Residual or Recurrent Grade 2 Glioma With an IDH1 or IDH2 Mutation (INDIGO)
- NCT number
- NCT04164901
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 331 participants, actual
- Lead sponsor
- Institut de Recherches Internationales Servier
- Conditions
- Grade 2 Glioma, Residual Glioma, Recurrent Glioma
- Interventions
- Vorasidenib, Matching Placebo
- First posted
- 2019-11-15
- Last updated
- 2025-04-03
- Other registries' IDs
- eudract:2019-002481-13
- Results first posted
- 2023-11-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 30 months | PFS is defined as the time from date of randomization to date of first documented radiographic PD (as assessed by the blinded independent review committee (BIRC) per modified Response Assessment for Neuro-oncology for Low-Grade Gliomas or date of death due to any cause, whichever occurs earlier. |
| Secondary | Time to Next Intervention (TTNI) | Up to approximately 3 years | TTNI is defined as the time from randomization to the initiation of the first subsequent anticancer therapy (including vorasidenib, for subjects randomized to placebo who subsequently cross over) or death due to any cause. |
| Secondary | Tumor Growth Rate (TGR) | every 6 months, up to 2 years and 9 months | Calculated as the mean of the percentage change in tumor volume every 6 months |
| Secondary | Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | approximatively 30 months | OR is defined as a best overall response (BOR) of Complete Response, Partial Rresponse, or minor Response as assessed by the BIRC per the modified Response Assessment in Neuro-oncology for Low-grade Gliomas (RANO-LGG). |
| Secondary | Complete Response (CR) and Partial Response (PR) by BIRC | Approximatively 30 months | CR and PR is defined as a BOR of CR or PR as assessed by BIRC per the modified RANO-LGG |
| Secondary | Time to Response (TTR) by BIRC | Approximatively 30 months | TTR is defined as the time from the date of randomization to the date of first documented CR, PR, or mR by BIRC per the modified RANO-LGG |
| Secondary | Time to CR+PR by BIRC | Approximatively 30 months | Time to CR+PR is defined as defined as the time from the date of randomization to the date of first documented CR or PR for subjects with CR or PR per the modified RANO-LGG (by BIRC) |
| Secondary | Duration of Response (DoR) | Approximatively 30 months | DoR is defined as the time from the date of first documented CR, PR, or mR to the date of death due to any cause or date of first documented radiographic Prgressive Disease, whichever occurred earlier |
| Secondary | Duration of CR+PR | Approximatively 30 months | Duration of CR+PR is defined as the time from the date of first documented CR or PR to the date of death due to any cause or first documented radiographic PD, whichever occurred earlier |
| Secondary | Overall Survival (OS) | Approximatively 30 months | OS wad defined as the time from the date of randomization to the date of death due to any cause or data cutoff. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) | Up to approximately 30 months | months | MEDIAN | |
| SECONDARY | Time to Next Intervention (TTNI) | Up to approximately 3 years | months | MEDIAN | |
| SECONDARY | Tumor Growth Rate (TGR) | every 6 months, up to 2 years and 9 months | percent change | MEAN | |
| SECONDARY | Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | approximatively 30 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Complete Response (CR) and Partial Response (PR) by BIRC | Approximatively 30 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Time to Response (TTR) by BIRC | Approximatively 30 months | The number of participants with CR, PR or mR was 18 and 4, respectively in the vorasidenib and placebo groups. The median time duration of response is analysed only on participants with response. | months | MEDIAN |
| SECONDARY | Time to CR+PR by BIRC | Approximatively 30 months | The number of participants with CR or PR was 2 and 0, respectively in the vorasidenib and placebo groups. The median time duration of response is analysed only on participants with response. | months | MEDIAN |
| SECONDARY | Duration of Response (DoR) | Approximatively 30 months | months | MEDIAN | |
| SECONDARY | Duration of CR+PR | Approximatively 30 months | The number of participants with CR or PR was 2 and 0, respectively in the vorasidenib and placebo groups. In the placebo group, no participants experienced the event. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | Approximatively 30 months | This is based off of the participants in the Safety Set, which includes all subjects that received one least one dose of treatment. The months of survival represent the time between randomization and the data cutoff point, since during the study there were no deaths. | months | MEDIAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) | Vorasidenib | 27.7 | 95% Confidence Interval 17.0 to NA | months | |
| Progression-Free Survival (PFS) | Matching Placebo | 11.1 | 95% Confidence Interval 11.0 to 13.7 | months | |
| Time to Next Intervention (TTNI) | Vorasidenib | NA | 95% Confidence Interval NA to NA | months | |
| Time to Next Intervention (TTNI) | Matching Placebo | 17.8 | 95% Confidence Interval 15.0 to NA | months | |
| Tumor Growth Rate (TGR) | Vorasidenib | -2.5 | 95% Confidence Interval -4.7 to -0.2 | percent change | |
| Tumor Growth Rate (TGR) | Matching Placebo | 13.9 | 95% Confidence Interval 11.1 to 16.8 | percent change | |
| Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | Vorasidenib | 18 | Participants | ||
| Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | Matching Placebo | 4 | Participants | ||
| Complete Response (CR) and Partial Response (PR) by BIRC | Vorasidenib | 2 | Participants | ||
| Complete Response (CR) and Partial Response (PR) by BIRC | Matching Placebo | 0 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vorasidenib | 168 | |
| Overall Study | STARTED | Matching Placebo | 163 | |
| Overall Study | COMPLETED | Vorasidenib | 164 | |
| Overall Study | COMPLETED | Matching Placebo | 159 | |
| Overall Study | NOT COMPLETED | Vorasidenib | 4 | |
| Overall Study | NOT COMPLETED | Matching Placebo | 4 |
Source ClinicalTrials.gov
Adverse events86
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 | Vorasidenib | 45 | 167 | |
| other | Headache | Nervous system disorders | Matching Placebo | 44 | 163 | |
| other | Dizziness | Nervous system disorders | Vorasidenib | 25 | 167 | |
| other | Dizziness | Nervous system disorders | Matching Placebo | 26 | 163 | |
| other | Seizure | Nervous system disorders | Vorasidenib | 18 | 167 | |
| other | Seizure | Nervous system disorders | Matching Placebo | 16 | 163 | |
| other | Paraesthesia | Nervous system disorders | Vorasidenib | 11 | 167 | |
| other | Paraesthesia | Nervous system disorders | Matching Placebo | 10 | 163 | |
| other | Diarrhoea | Gastrointestinal disorders | Vorasidenib | 41 | 167 | |
| other | Diarrhoea | Gastrointestinal disorders | Matching Placebo | 27 | 163 |
1 to 10 of 86Source ClinicalTrials.gov
See all 86 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vorasidenib | 0 | 167 |
| Total, all-cause mortality | Matching Placebo | 0 | 163 |
| Total, other adverse events | Vorasidenib | 158 | 167 |
| Total, other adverse events | Matching Placebo | 152 | 163 |
| Total, serious adverse events | Vorasidenib | 11 | 167 |
| Total, serious adverse events | Matching Placebo | 8 | 163 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vorasidenib vs Matching Placebo: Objective Response (OR) as Assessed by the Blinded Independent Review Committee (BIRC) | Trial comparisons |
| Vorasidenib vs Matching Placebo: Complete Response (CR) and Partial Response (PR) by BIRC | Trial comparisons |
| Vorasidenib vs Matching Placebo: deaths from any cause | Trial comparisons |
| Vorasidenib vs Matching Placebo: 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/NCT04164901
GET https://conductscience.org/api/trials/v1/NCT04164901/results?page=2