Ignite Creation Date:
2024-05-06 @ 9:23 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02960230
Status:
COMPLETED
Last Update Posted:
2024-02-22
First Post:
2016-11-02
Brief Title:
H33K27M Peptide Vaccine With Nivolumab for Children With Newly Diagnosed DIPG and Other Gliomas
Sponsor:
Sabine Mueller MD PhD
Organization:
University of California San Francisco
Study Overview
Official Title:
H33K27M Specific Peptide Vaccine Combined With Poly-ICLC With and Without PD-1 Inhibition Using Nivolumab for the Treatment of Newly Diagnosed HLA-A2 0201 H33K27M Positive Diffuse Intrinsic Pontine Glioma DIPG and Newly Diagnosed HLA-A2 0201 H33K27M Positive Gliomas
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 H33K27M epitope given in combination with poly-ICLC and the H33K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor nivolumab in HLA-A2 0201 children with newly diagnosed DIPG or other midline gliomas that are positive for H33K27M
This study will assess the safety and immune activity of a synthetic peptide vaccine specific for the H33K27M epitope given in combination with poly-ICLC and the H33K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor nivolumab in HLA-A2 0201 children with newly diagnosed DIPG or other midline gliomas that are positive for H33K27M
Detailed Description:
Subjects who are eligible will receive a specific peptide vaccine along with a helper drug called poly-ICLC in combination with nivolumab every 3 weeks for the first 6 months of treatment Subjects will be monitored routinely by laboratory assessments physical evaluation vital signs and MRI Subjects who tolerate therapy well and have stable or improved disease after 6 months of treatment can continue to receive treatment nivolumab continuing every 3 weeks but vaccine and poly-ICLC now every 6 weeks for a total of 96 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CA209-8TX | OTHER | Bristol-Meyers Squibb | None |
| 150819 | OTHER | None | None |
| NCI-2017-01830 | OTHER | None | None |