Phase II open-label global study to evaluate the effect of dabrafenib in combination with trametinib in children and adolescent patients with BRAF V600 mutation positive Low Grade Glioma (LGG) or relapsed or refractory High Grade Glioma (HGG)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Zanthiastrocytoma | Rosette-forming Glioneurona Tumor | Glioma | Astrocytoma | Iponeurocytoma | Low Grade Glioma (LGG) | High Grade Glioma | Glioblastoma | BRAF mutation | Papillary Glioneuronal Tumor | relapsed or refractory High Grade Glioma (HGG) | Oligodenroglioma | Low Grade Glioma | Neurocytoma | Gangliocytoma
  • Age: Between 1 - 17 Years
  • Gender: Male or Female

Inclusion Criteria


Diagnosis of BRAF V600 mutant High Grade glioma that has relapsed, progressed or failed to respond to frontline therapy

Diagnosis of BRAF V600 mutant Low Grade glioma with progressive disease following surgical excision, or non-surgical candidates with necessity to begin first systemic treatment because of a risk of neurological impairment with progression.

Confirmed measurable disease

Exclusion Criteria

Previous treatment with dabrafenib, trametinib, other RAF inhibitor, other MEK or ERK inhibitor

HGG patient: Cancer treatment within the past 3 weeks.

LGG patient: Any systemic therapy or radiotherapy prior to enrollment

LGG patients: history of allergic reaction or contraindications to the use of carboplatin or vincristine

Stem cell transplant within the past 3 months

History of heart disease

Pregnant or lactating females

Recruitment Status

Open

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