Trial · NCT02960230
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
NCT02960230, Phase 1, Phase 2, Completed, Sabine Mueller, MD, PhD; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas. Trials, record NCT02960230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02960230
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
- NCT number
- NCT02960230
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Sabine Mueller, MD, PhD
- Conditions
- Diffuse Intrinsic Pontine Glioma, Glioma, Diffuse Midline Glioma, H3 K27M-Mutant
- Interventions
- K27M peptide, Nivolumab
- First posted
- 2016-11-09
- Last updated
- 2025-01-22
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events (AE) Related to Treatment | 24 months | Safety of the vaccine (Strata A and B) or vaccine in combination with nivolumab (Stratum C) will be assessed for participants who received the vaccination. The severity of toxicities will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE)version 5.0. and include any clinically-significant lab abnormalities meeting Grade 3, 4, or 5 criteria according to CTCAE. Grade 1 \& 2 AEs will be summarized if probably, possible, or definitely related to study therapy. Descriptive statistics will be utilized to display the data on toxicity reported by participants. |
| Primary | Overall Survival Rate at 12 Months (OS12) (Stratum A Only) | 12 months | OS12 is defined as the percentage of participants still alive at 12 months, and is the clinical efficacy, primary endpoint for Stratum A. Any eligible participant that received at least one dose of the K27M/TT vaccine will be considered evaluable for clinical efficacy. OS12 will be censored at the last contact date and estimated using the Kaplan-Meier method. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Adverse Events (AE) Related to Treatment | 24 months | percentage of participants | NUMBER | |
| PRIMARY | Overall Survival Rate at 12 Months (OS12) (Stratum A Only) | 12 months | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group367
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum A: Newly Diagnosed DIPG | Abdominal Pain | 5.26 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | Abdominal Pain | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | Abdominal Pain | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum A: Newly Diagnosed DIPG | Abducens Nerve Disorder | 21.0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | Abducens Nerve Disorder | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | Abducens Nerve Disorder | 9.5 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum A: Newly Diagnosed DIPG | Acoustic Nerve Disorder | 5.26 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | Acoustic Nerve Disorder | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | Acoustic Nerve Disorder | 0 | percentage of participants | |
| Percentage of Participants With Adverse Events (AE) Related to Treatment | Stratum A: Newly Diagnosed DIPG | Adult respiratory distress syndrome | 0 | percentage of participants |
1 to 10 of 367Source ClinicalTrials.gov
See all 367 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stratum A: Newly Diagnosed DIPG | 19 | |
| Overall Study | STARTED | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 10 | |
| Overall Study | STARTED | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 21 | |
| Overall Study | COMPLETED | Stratum A: Newly Diagnosed DIPG | 19 | |
| Overall Study | COMPLETED | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 10 | |
| Overall Study | COMPLETED | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 21 | |
| Overall Study | NOT COMPLETED | Stratum A: Newly Diagnosed DIPG | 0 | |
| Overall Study | NOT COMPLETED | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 0 | |
| Overall Study | NOT COMPLETED | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 0 |
Source ClinicalTrials.gov
Adverse events612
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 | Anemia | Blood and lymphatic system disorders | Stratum A: Newly Diagnosed DIPG | 3 | 19 | 3 |
| other | Anemia | Blood and lymphatic system disorders | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 2 | 10 | 10 |
| other | Anemia | Blood and lymphatic system disorders | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 4 | 21 | 7 |
| other | Eosinophilia | Blood and lymphatic system disorders | Stratum A: Newly Diagnosed DIPG | 0 | 19 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 0 | 10 | 0 |
| other | Eosinophilia | Blood and lymphatic system disorders | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 3 | 21 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stratum A: Newly Diagnosed DIPG | 2 | 19 | 3 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 0 | 10 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 0 | 21 | 0 |
| other | Sinus bradycardia | Cardiac disorders | Stratum A: Newly Diagnosed DIPG | 0 | 19 | 0 |
1 to 10 of 612Source ClinicalTrials.gov
See all 612 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stratum A: Newly Diagnosed DIPG | 17 | 19 |
| Total, all-cause mortality | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 7 | 10 |
| Total, all-cause mortality | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 20 | 21 |
| Total, other adverse events | Stratum A: Newly Diagnosed DIPG | 19 | 19 |
| Total, other adverse events | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 10 | 10 |
| Total, other adverse events | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 21 | 21 |
| Total, serious adverse events | Stratum A: Newly Diagnosed DIPG | 6 | 19 |
| Total, serious adverse events | Stratum B: Newly Diagnosed Glioma (Non-DIPG) | 8 | 10 |
| Total, serious adverse events | Stratum C: Newly Diagnosed DIPG or Other Midline Glioma | 13 | 21 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32817593 | DERIVED |
Source 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 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/NCT02960230
GET https://conductscience.org/api/trials/v1/NCT02960230/results?page=2