OncoMatch/Clinical Trials/NCT06712875
MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas
Is NCT06712875 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Trametinib and Nivolumab and Dabrafenib, trametinib, nivolumab for low grade glioma.
Treatment: Trametinib and Nivolumab · Dabrafenib, trametinib, nivolumab — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: BRAF KIAA1549-BRAF fusion
harboring a KIAA1549-BRAF fusion
Required: NF1 NF1-associated glioma or NF1-altered glioma
Patients with NF1-associated gliomas or NF1-altered glioma
Required: BRAF V600 mutation
harboring BRAFV600 mutation
Prior therapy
Must have received: BRAF inhibitor — Low Grade Glioma only
Patients must have received a prior BRAF inhibitor (first or second generation), MEK inhibitor, or a combination. The response to this therapy must be known and information provided at study enrollment.
Must have received: MEK inhibitor — Low Grade Glioma only
Patients must have received a prior BRAF inhibitor (first or second generation), MEK inhibitor, or a combination. The response to this therapy must be known and information provided at study enrollment.
Must have received: radiation therapy — High Grade Glioma only
Patients must have received prior radiotherapy >12 weeks prior to enrollment.
Cannot have received: MAPK inhibitor and checkpoint blockade combination therapy
Patients who have received MAPK inhibitor and checkpoint blockade combination therapy.
Cannot have received: BRAF inhibitor
Exception: if discontinued due to grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation
Patients who previously discontinued BRAF inhibitor (type 1 inhibitor or dimer inhibitor, such as, DAY101), MEK inhibitor, or the combination because of grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation of therapy are not eligible.
Cannot have received: MEK inhibitor
Exception: if discontinued due to grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation
Patients who previously discontinued BRAF inhibitor (type 1 inhibitor or dimer inhibitor, such as, DAY101), MEK inhibitor, or the combination because of grade 3 or higher toxicity or clinically significant grade 2 toxicity requiring discontinuation of therapy are not eligible.
Lab requirements
Blood counts
adequate organ and bone marrow function required
Kidney function
adequate organ and bone marrow function required
Liver function
adequate organ and bone marrow function required
Patients must have adequate organ and bone marrow function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Children's National Hospital · Washington D.C., District of Columbia
- Ann & Robert H. Lurie Children's Hospital of Chicago · Chicago, Illinois
- Memorial Sloan Kettering Cancer Center · New York, New York
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