Study of Tovorafenib in High-Grade Glioma and Diffuse Intrinsic Pontine Glioma (DIPG)

Sponsor
Nationwide Children's Hospital
Study ID
NCT07206849
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Diffuse Intrinsic Pontine Glioma
  • High Grade Glioma
  • High Grade Glioma (HGG) of the Brain With BRAF Aberration
  • High Grade Glioma (III or IV)
  • Metastatic Brain Tumor
  • WHO Grade 3 Glioma
  • WHO Grade 4 Glioma

Eligibility Criteria

Sex
ALL
Age
12 Months - 39 Years
Healthy Volunteers
Not accepted

Interventions

  • Tovorafenib — DRUG
    Tovorafenib will be given orally once weekly (QW) throughout each cycle.

Study Details

The goal of this study is to determine the efficacy of the study drugs tovorafenib to treat pediatric and young adult patients newly diagnosed with a high-grade glioma (HGG), including DIPG, that have genetic changes in pathways (MAPK) that this drug targets. The main question the study aims to answer is whether tovorafenib can prolong the life of patients diagnosed with HGG, including DIPG.

Key Dates

First listed
Oct 3, 2025
Start date
May 31, 2026
Status verified
Apr 2026
Primary completion
May 31, 2030
Completion
May 31, 2037

Study Design

Enrollment
79 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Stratum A - localized HGG
    Patients with intracranial, localized, non-pontine, and non-thalamic HGG harboring a BRAFV600 mutation (who do not meet criteria for Strata B or C).
  • Experimental: Stratum B - DIPG
    Patients with DIPG/DMG as defined in Section 4.1.3 OR patients with localized, non-pontine, non-thalamic HGG harboring a MAPK alteration not included in Stratum A (KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration) OR patients with primary spinal tumors.
  • Experimental: Stratum C - metastatic HGG
    Patients with metastatic HGG (including metastatic DIPG/DMG) harboring a MAPK alteration (BRAFV600, KIAA1549:BRAF fusion, KRAS/NRAS, CRAF/RAF1, other RAF mutation, or FGFR alteration).

Primary Outcome Measure

Progression Free Survival Stratum A [ Time Frame: 6 years ]

Central Contacts

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