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NCT02960230 · ClinicalTrials.gov registry record · Phase 1
H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
A Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT02960230: Completed Phase 1 study, sponsored by Sabine Mueller, MD, PhD.
NCT02960230 is a Phase 1 study that has completed, run by Sabine Mueller, MD, PhD. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02960230, a Phase 1 study, has completed, sponsored by Sabine Mueller, MD, PhD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is 3-arm, multicenter study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC). This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the Histone 3 lysine27-to-methionine (H3.3K27M) epitope given in combination with poly-ICLC and the H3.3K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor, nivolumab, in HLA-A2 (02:01)+ children with newly diagnosed diffuse intrinsic pontine glioma (DIPG) or other midline gliomas that are positive for H3.3K27M.
Primary Outcome
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. Desc
Interventions
- DRUG Nivolumab
- BIOLOGICAL K27M peptide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2016-11-18 |
| Est. Completion | 2023-12-31 |
| Phase | Phase 1 |
What the finished NCT02960230 record still lists
NCT02960230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Nivolumab is the first listed.
NCT02960230 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02960230 about?
NCT02960230 is a clinical study titled "H3.3K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas". This is 3-arm, multicenter study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC). This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the Histone 3 lysine27-to-methionine (H3.3K27M) epitope given in combination with ...
What is the current status of trial NCT02960230?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2016-11-18. Estimated completion is 2023-12-31.
What interventions are being tested in trial NCT02960230?
The interventions under investigation include: Nivolumab (DRUG), K27M peptide (BIOLOGICAL).
Who is sponsoring clinical trial NCT02960230?
This trial is sponsored by Sabine Mueller, MD, PhD, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02960230's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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