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NCT05096481 · ClinicalTrials.gov registry record · Phase 2
PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma
A Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
- 12
- Study locations
NCT05096481: Recruiting Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, sponsored by Nationwide Children's Hospital.
NCT05096481 is a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 120 participants, above the 63-participant average among 42 other High Grade Glioma trials with a reported enrollment target (90% higher). The trial reports 12 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05096481, a Phase 2 study of High Grade Glioma and Diffuse Intrinsic Pontine Glioma, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
- 12
- Study locations
Study Summary
This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a vaccine mixture of a peptide referred to as Component A. Component A is a synthetic long peptide (SLP) of 26 amino acid residues from human pp65. The SLPs encode multiple potential class I, class II, and antibody epitopes across several haplotypes. Component A will be administered as a stable water:oil emulsion in Montanide ISA 51. Funding Source - FDA OOPD
Primary Outcome
To determine the progression-free survival (PFS) at 4 months in pediatric or young adult patients with recurrent medulloblastoma treated with PEP-CMV.
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL PEP-CMV
- BIOLOGICAL Tetanus Diphtheria Vaccine
Study Locations (12)
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
- Nationwide Children's Hospital - Columbus
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Medical Center - Washington D.C.
Florida
- Nicklaus Children's Hospital - Miami
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Massachusetts
- Dana-Farber Cancer Institute - Boston
Missouri
- St. Louis Children's Hospital - St Louis
North Carolina
- Duke Cancer Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2030-06-15 |
| Phase | Phase 2 |
What NCT05096481 shows while recruiting
NCT05096481 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 63-participant average among 42 other High Grade Glioma trials with a reported enrollment target (90% higher).
The record links to 3 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 3 interventions - of which Temozolomide is the first listed.
NCT05096481 lists 12 locations in 11 states (Ohio, Colorado, District of Columbia).
Frequently Asked Questions
What is clinical trial NCT05096481 about?
NCT05096481 is a clinical study titled "PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma". This study will address the question of whether targeting CMV antigens with PEP-CMV can serve as a novel immunotherapeutic approach in pediatric patients with newly-diagnosed high-grade glioma (HGG) or diffuse intrinsic pontine glioma (DIPG) as well as recurrent medulloblastoma (MB). PEP-CMV is a v...
What is the current status of trial NCT05096481?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2024-07-18. Estimated completion is 2030-06-15.
What conditions does trial NCT05096481 study?
This clinical trial studies the following conditions: High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma.
What interventions are being tested in trial NCT05096481?
The interventions under investigation include: Temozolomide (DRUG), PEP-CMV (BIOLOGICAL), Tetanus Diphtheria Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT05096481?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05096481 being conducted?
This trial has 12 study locations across Colorado, District of Columbia, Florida, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for High Grade Glioma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05096481's enrollment target sits among peer trials
120 3rd of 42 higher than 39 of 42 other High Grade Glioma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other High Grade Glioma 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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