Trial · NCT05476939
Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
NCT05476939, Phase 3, Recruiting, Gustave Roussy, Cancer Campus, Grand Paris
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0. Trials, record NCT05476939. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05476939
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Biological Medicine for Diffuse Intrinsic Pontine Glioma (DIPG) Eradication 2.0
- NCT number
- NCT05476939
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 433 participants, estimated
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Conditions
- Diffuse Intrinsic Pontine Glioma, Diffuse Midline Glioma, H3 K27M-Mutant, Diffuse Midline Glioma, H3K27-altered
- Interventions
- Everolimus, ONC201, Radiotherapy
- First posted
- 2022-07-27
- Last updated
- 2026-10-21
- Other registries' IDs
- eudract:2014-001929-32
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival | Until 2 years after inclusion of the last patient | Defined as the time between date of randomization and unequivocal clinical, cytological or radiological progression confirmed by central review, or death whatever the cause. |
| Secondary | Overall survival (for all the comparisons to historical controls) | Until 5 years after randomization of the last patient | Defined from the date of radiological diagnosis to the date of death from any cause. |
| Secondary | Overall survival (for the internal comparison between randomized groups) | Until 5 years after randomization of the last patient | Defined from the date of randomization to the date of death from any cause. |
| Secondary | Progression-free survival after first progression | Until 5 years after randomization of the last patient | It will also be computed from the date of progression to the date of subsequent progression or death from any cause, in order to describe the outcome after progression. |
| Secondary | Complication rate of the diagnostic biopsy-based procedure | Until 5 years after randomization of the last patient | |
| Secondary | Severity of the complications (including prolongation of the hospital stay) of the diagnostic biopsy-based procedure | Until 5 years after randomization of the last patient | |
| Secondary | Duration of the complications (including delay for starting treatment) of the diagnostic biopsy-base procedure | Until 5 years after randomization of the last patient | |
| Secondary | Safety profile of the drugs | Until 5 years after randomization of the last patient | Using the NCI-CTC v5.0 criteria, during radiotherapy and during the entire duration of the administration of the drug, considering all adverse events except adverse events unequivocally related to the disease (pseudo)-progression. |
| Secondary | Relative benefit/risk ratio of ONC201 compared to everolimus | Until 5 years after randomization of the last patient | It will be assessed using the Q-TWiST approach (Quality-adjusted time without symptoms of disease or adverse event) evaluated from survival times (overall survival and progression-free survival) and adverse events data (date of occurrence of grade 3+ adverse event). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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.
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/NCT05476939
GET https://conductscience.org/api/trials/v1/NCT05476939/registered