TriangleNCT02960230 · STUDY IN CONTEXT
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
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.
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.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- trial label
- H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
- applicability
- narrower
- applicability note
- Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 2
- harms Count
- 3
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0000
- source section id
- NCT02960230-om-0000
- source outcome index
- 0
- endpoint
- Percentage of Participants With Adverse Events (AE) Related to Treatment
- endpoint definition
- 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.
- time origin
- 24 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0001
- source section id
- NCT02960230-om-0001
- source outcome index
- 1
- endpoint
- Overall Survival Rate at 12 Months (OS12) (Stratum A Only)
- endpoint definition
- 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.
- time origin
- 12 months
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Stratum A: Newly Diagnosed DIPG
- regimen
- Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02960230-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Stratum B: Newly Diagnosed Glioma (Non-DIPG)
- regimen
- Newly diagnosed children with gliomas other than DIPG who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
- analyzed count
- 10
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02960230-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0000
- arm key
- OG002
- arm label
- Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
- regimen
- Newly diagnosed children with DIPG or other midline gliomas (excluding primary spinal cord tumors) who are positive for HLA-A2 (02:01) and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Nivolumab will also be given via IV. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks. Nivolumab will continue to be given every 3 weeks throughout all of treatment.
- analyzed count
- 21
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02960230-om-0000#groups/OG002
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Stratum A: Newly Diagnosed DIPG
- regimen
- Newly diagnosed children with diffuse intrinsic pontine glioma who are positive for HLA-A2 and the H3.3K27M mutation that underwent radiation therapy will receive the specific H3.3K27M peptide vaccine, combined with the tetanus toxoid (TT) peptide, emulsified in Montanide. Poly-ICLC, which is a synthetic nucleic acid, will be given concurrently to improve the therapeutic effects of the vaccine. Vaccine will be given every 3 weeks for the first 24 weeks, then if there is stable or improved disease, will be given every 6 weeks for a total treatment period of 96 weeks.
- analyzed count
- 19
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT02960230-om-0001#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- harm key
- EG000
- source section id
- NCT02960230-ae
- event group key
- EG000
- event group label
- Stratum A: Newly Diagnosed DIPG
- serious affected
- 6
- serious at risk
- 19
- other affected
- 19
- other at risk
- 19
- frequency threshold
- 0
- collection period
- Up to 24 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- harm key
- EG001
- source section id
- NCT02960230-ae
- event group key
- EG001
- event group label
- Stratum B: Newly Diagnosed Glioma (Non-DIPG)
- serious affected
- 8
- serious at risk
- 10
- other affected
- 10
- other at risk
- 10
- frequency threshold
- 0
- collection period
- Up to 24 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-diffuse-intrinsic-pontine-glioma-dipg
- nct id
- NCT02960230
- harm key
- EG002
- source section id
- NCT02960230-ae
- event group key
- EG002
- event group label
- Stratum C: Newly Diagnosed DIPG or Other Midline Glioma
- serious affected
- 13
- serious at risk
- 21
- other affected
- 21
- other at risk
- 21
- frequency threshold
- 0
- collection period
- Up to 24 months
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice