Glioma Clinical Trial
Official title:
H3.3K27M Specific Peptide Vaccine Combined With Poly-ICLC With and Without PD-1 Inhibition Using Nivolumab for the Treatment of Newly Diagnosed HLA-A2 (02:01)+ H3.3K27M Positive Diffuse Intrinsic Pontine Glioma (DIPG) and Newly Diagnosed HLA-A2 (02:01)+ H3.3K27M Positive 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 H3.3.K27M epitope given in combination with poly-ICLC and the H3.3.K27M epitope given in combination with poly-ICLC and the PD-1 inhibitor, nivolumab, in HLA-A2 (02:01)+ children with newly diagnosed DIPG or other midline gliomas that are positive for H3.3K27M.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04539574 -
An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors
|
N/A | |
| Enrolling by invitation |
NCT04461002 -
Evaluation of the Correlation Between Molecular Phenotype and Radiological Signature (by PET-scanner and MRI) of Incident WHO II and III Grade Gliomas.
|
||
| Terminated |
NCT01902771 -
Dendritic Cell Vaccine Therapy With In Situ Maturation in Pediatric Brain Tumors
|
Phase 1 | |
| Completed |
NCT03242824 -
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
|
Phase 2 | |
| Recruiting |
NCT04186832 -
Step Count Monitoring as a Measure of Physical Activity in Patients With Newly Diagnosed Glioma Undergoing Radiation Therapy
|
N/A | |
| Completed |
NCT00424554 -
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)
|
Phase 2 | |
| Recruiting |
NCT05968053 -
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
|
||
| Not yet recruiting |
NCT04550663 -
NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors
|
Phase 1 | |
| Completed |
NCT02805179 -
A Study of High-Dose Chemoradiation Using Biologically-Based Target Volume Definition in Patients With Glioblastoma
|
Phase 2 | |
| Terminated |
NCT04556929 -
Enhanced Detection in Glioma Excision
|
N/A | |
| Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
| Recruiting |
NCT06043232 -
MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas
|
||
| Not yet recruiting |
NCT06043765 -
Reducing Cognitive Impairment in Glioma With Repetitive Transcranial Magnetic Stimulation and Cognitive Strategy Training
|
N/A | |
| Not yet recruiting |
NCT05025969 -
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
|
||
| Completed |
NCT02978261 -
Study of a c-Met Inhibitor PLB1001 in Patients With PTPRZ1-MET Fusion Gene Positive Recurrent High-grade Gliomas
|
Phase 1 | |
| Terminated |
NCT01502605 -
Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
|
Phase 1 | |
| Completed |
NCT01836536 -
Search for a Link Between Response to Treatment and Circulating Leucocytes in High Grade Glioma Patients
|
N/A | |
| Completed |
NCT01479686 -
iMRI Guided Resection in Cerebral Glioma Surgery
|
Phase 3 | |
| Completed |
NCT01212731 -
Skull Base and Low Grade Glioma Neurocognitive Magnetic Resonance Imaging (MRI) Study
|
||
| Terminated |
NCT01044966 -
A Study of Intraventricular Liposomal Encapsulated Ara-C (DepoCyt) in Patients With Recurrent Glioblastoma
|
Phase 1/Phase 2 |