Trial Profile

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) P/260/2017

Status: Completed

Phase of Trial: Phase II/III

Latest Information Update: 03 Mar 2026

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At a glance

Drugs Dabrafenib (Primary) ; Trametinib (Primary) ; Carboplatin; Vincristine
Indications Glioma
Focus Registrational; Therapeutic Use
Acronyms TADPOLE
Sponsors Novartis Pharma A.G.; Novartis Pharmaceuticals

12 Sep 2023 Results (n=110) assessing OR and PFS in patients with pediatric low-grade glioma with BRAF V600 mutations who were scheduled to receive first-line therapy, published in the New England Journal of Medicine.
29 Aug 2023 Results (n=41) in pediatric patients, published in the Journal of Clinical Oncology
31 May 2023 The trial has been completed in Finland, according to European Clinical Trials Database record.

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