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Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

NCT07110246 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2026-04-30

No results posted yet for this study

Summary

This phase II trial studies how well de-escalating the drugs dabrafenib and trametinib works in treating patients with low-grade gliomas that have a BRAF V600 gene mutation. Dabrafenib and trametinib are in a class of medications called kinase inhibitors. They work by blocking the action of abnormal proteins that signals tumor cells to multiply. This helps stop the spread of tumor cells. This trial may help doctors determine the best dosing strategy for patients who have received dabrafenib and trametinib for 12-24 months: Either stopping dabrafenib and trametinib completely or slowly reducing the dose for an additional 6 months.

Conditions

  • BRAF V600 Mutation
  • Low-grade Glioma
  • Low Grade Glioma of Brain
  • Recurrent Low Grade Glioma

Interventions

DRUG

Dabrafenib

Given orally (PO)

DRUG

Trametinib

Given PO

PROCEDURE

Magnetic Resonance Imaging (MRI)

Undergo imaging by MRI

PROCEDURE

Specimen Collection

Under collection of blood and optional CSF samples

PROCEDURE

Optional Lumbar puncture

Undergo optional lumbar puncture

Sponsors & Collaborators

Principal Investigators

  • Sabine Mueller, MD, PHD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2032-03-31
Completion
2032-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07110246 on ClinicalTrials.gov