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NCT06712875 · ClinicalTrials.gov registry record · Phase 1
MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas
A Phase 1 study of High Grade Glioma and Low Grade Glioma, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 3
- Study locations
NCT06712875 is a Phase 1 study of High Grade Glioma and Low Grade Glioma that is actively recruiting participants, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 27 participants, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (58% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT06712875, a Phase 1 study of High Grade Glioma and Low Grade Glioma, is actively recruiting participants, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 3
- Study locations
Study Summary
Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and/or trametinib. Unfortunately, some BRAF-altered gliomas can progress or have rebound growth after discontinuation of therapy. Data from BRAFV600E-mutant melanoma has shown potential synergy between MAPK inhibition and anti-programmed cell death 1 (anti-PD1) checkpoint blockade. Anti-PD1 therapy, such as, nivolumab can block the PD1 receptor on T cells, a marker of T cell exhaustion, allowing a continued or more robust anti-tumor immune response. Here, investigators will combine MAPK inhibition with anti-PD1 therapy in recurrent, refractory low grade BRAF-altered glioma and newly diagnosed or recurrent BRAF-altered or NF-altered high grade glioma.
Conditions Studied
Interventions
- DRUG Trametinib and Nivolumab
- DRUG Dabrafenib, trametinib, nivolumab
Study Locations (3)
District of Columbia
- Children's National Hospital - Washington D.C.
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
New York
- Memorial Sloan Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2025-04-01 |
| Est. Completion | 2029-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06712875
The ClinicalTrials.gov registry entry for NCT06712875 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 27 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 65-participant average among 42 other High Grade Glioma trials with a reported enrollment target (58% lower). The listed sponsor is Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with High Grade Glioma appearing as the primary indexed condition, and to 2 interventions - of which Trametinib and Nivolumab is the first listed.
NCT06712875 reports 3 study locations spanning 3 distinct geographic areas - top geographies include District of Columbia, Illinois, New York.
Frequently Asked Questions
What is clinical trial NCT06712875 about?
NCT06712875 is a clinical study titled "MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas". Pediatric gliomas harboring BRAF-alterations, commonly BRAFV600 mutation or KIAA1549-BRAF fusion, are currently treated with either chemotherapy or mitogen activated protein kinase (MAPK) inhibitors, such as, dabrafenib and/or trametinib. Unfortunately, some BRAF-altered gliomas can progress or have...
What is the current status of trial NCT06712875?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2025-04-01. Estimated completion is 2029-06.
What conditions does trial NCT06712875 study?
This clinical trial studies the following conditions: High Grade Glioma, Low Grade Glioma.
What interventions are being tested in trial NCT06712875?
The interventions under investigation include: Trametinib and Nivolumab (DRUG), Dabrafenib, trametinib, nivolumab (DRUG).
Who is sponsoring clinical trial NCT06712875?
This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06712875 being conducted?
This trial has 3 study locations across District of Columbia, Illinois, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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