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PEP-CMV Vaccine Targeting CMV Antigen to Treat Newly Diagnosed Pediatric HGG and DIPG and Recurrent Medulloblastoma

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria revised
    • Study description expanded, about 6 words
    v32
  2. Study sites: 12 to 13v31
  3. Eligibility criteria expanded, about 6 words
    • Collaborators expanded, about 2 words
    v30
  4. Site details revised at 2 of 12 sitesv29
  5. Site details revised at 1 of 12 sitesv28
Show 26 earlier versionsHide 26 earlier versions
  1. Site details revised at 1 of 12 sitesv27
  2. Site details revised at 1 of 12 sitesv26
  3. Eligibility criteria revised
    • Site contacts updated at 11 of 12 sites
    v25
  4. Study sites: 11 to 12v24
  5. Eligibility criteria revised
    • Site contacts updated at 11 of 11 sites
    v23
  6. Re-verified, no change to tracked fieldsv22
  7. Site details revised at 1 of 11 sitesv21
  8. Study sites: 10 to 11v20
  9. Start date: Jul 30, 2024 to Jul 18, 2024v19
  10. Site details revised at 2 of 10 sitesv18
  11. 3 versions Re-verified since Aug 7, 2024, no change to tracked fieldsv15-v17
  12. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised at 10 of 10 sites
    v14
  13. Start date: Jun 15, 2024 to Jul 30, 2024v13
  14. Start date: Apr 15, 2024 to Jun 15, 2024
    • Primary completion date: Apr 15, 2028 to Jun 15, 2028
    • Study completion date: Apr 15, 2030 to Jun 15, 2030
    v12
  15. Start date: Dec 15, 2023 to Apr 15, 2024
    • Primary completion date: Dec 15, 2027 to Apr 15, 2028
    • Study completion date: Dec 15, 2029 to Apr 15, 2030
    v11
  16. Primary completion date: May 15, 2027 to Dec 15, 2027
    • Start date: May 15, 2023 to Dec 15, 2023
    • Study completion date: May 15, 2029 to Dec 15, 2029
    v10
  17. Primary endpoints revised (3)
    • Secondary endpoints revised (3)
    v9
  18. Start date: Jan 15, 2023 to May 15, 2023
    • Primary completion date: Jan 15, 2027 to May 15, 2027
    • Study completion date: Jan 15, 2029 to May 15, 2029
    v8
  19. Start date: Nov 15, 2022 to Jan 15, 2023
    • Primary completion date: Nov 15, 2026 to Jan 15, 2027
    • Study completion date: Nov 15, 2028 to Jan 15, 2029
    v7
  20. Start date: Sep 15, 2022 to Nov 15, 2022
    • Primary completion date: Sep 15, 2026 to Nov 15, 2026
    • Study completion date: Sep 15, 2028 to Nov 15, 2028
    v6
  21. Start date: Mar 2022 to Sep 15, 2022
    • Primary completion date: Sep 2026 to Sep 15, 2026
    • Study completion date: Sep 2028 to Sep 15, 2028
    v5
  22. Site contacts updated at 1 of 10 sitesv4
  23. Re-verified, no change to tracked fieldsv3
  24. Study title shortened, about 3 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05096481
Lead Sponsor Nationwide Children's Hospital
Collaborators: Duke University
Conditions
(from sponsor)		 High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Recurrent Medulloblastoma
Related terms Diffuse Intrinsic Pontine Glioma, Glioma, Medulloblastoma
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov