RecruitingPhase 1Phase 2NCT06712875

MAPK Inhibition Combined With Anti-PD1 Therapy for BRAF-altered Pediatric Gliomas

A Pilot Study Evaluating the Toxicity and Clinical Benefit of Mitogen-activated Protein Kinase (MAPK) Pathway Inhibition Combined With Programmed Cell Death-1 Checkpoint Blockade (Anti-PD1) for the Treatment of BRAF-altered Pediatric Gliomas


Sponsor

Ann & Robert H Lurie Children's Hospital of Chicago

Enrollment

27 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 1 YearMax Age: 26 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Dabrafenib, trametinib, nivolumab and a drug called Trametinib and Nivolumab for people with high grade glioma and low-grade glioma. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 1 Year to 26 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrametinib and Nivolumab

Trametinib combined with nivolumab (Cohort A)

DRUGDabrafenib, trametinib, nivolumab

Dabrafenib + trametinib combined with nivolumab (Cohort B)


Locations(3)

Children's National Hospital

Washington D.C., District of Columbia, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

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NCT06712875


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