Dabrafenib and Trametinib for BRAF V600 Mutant Low-Grade Gliomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of California, San Francisco
Study ID
NCT07110246
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
12 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Dabrafenib — DRUG
    Given orally (PO)
  • Trametinib — DRUG
    Given PO
  • Magnetic Resonance Imaging (MRI) — PROCEDURE
    Undergo imaging by MRI
  • Specimen Collection — PROCEDURE
    Under collection of blood and optional CSF samples
  • Optional Lumbar puncture — PROCEDURE
    Undergo optional lumbar puncture

Study Details

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.

Key Dates

Start date
Nov 7, 2025
Status verified
Jun 2026
Primary completion
Mar 31, 2032
Completion
Mar 31, 2032

Study Design

Enrollment
96 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1: Arm A (Newly diagnosed, Dabrafenib, Trametinib followed by treatment stop)
    Participants with newly diagnosed BRAF V600 mutant LGGs receive dabrafenib PO twice per day (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for a minimum of 12 cycles and continues until confirmed best response or for up to a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. Participants then stop treatment with dabrafenib and trametinib. Participants also undergo ECHO, MRI, and blood sample collection throughout the study and may optionally undergo lumbar puncture for collection of CSF.
  • Experimental: Cohort 1: Arm B (Newly diagnosed, Dabrafenib, Trametinib followed by weaning)
    Participants with newly diagnosed BRAF V600 mutant LGGs receive dabrafenib PO twice per day (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for a minimum of 12 cycles and continues until confirmed best response or for up to a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. Participants then receive dabrafenib PO BID and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo ECHO, MRI, and blood sample collection throughout the study and may optionally undergo lumbar puncture for collection of CSF.
  • Experimental: Cohort 2: Arm A (Recurrent LGG, Dabrafenib, Trametinib followed by treatment stop)
    Participants with recurrent/progressive BRAF V600 mutant LGGs receive dabrafenib PO twice per day (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for a minimum of 12 cycles and continues until confirmed best response or for up to a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. Participants then stop treatment with dabrafenib and trametinib. Participants also undergo ECHO, MRI, and blood sample collection throughout the study and may optionally undergo lumbar puncture for collection of CSF.
  • Experimental: Cohort 2: Arm B (Recurrent LGG, Dabrafenib, Trametinib followed by weaning)
    Participants with recurrent/progressive BRAF V600 mutant LGGs receive dabrafenib PO twice per day (BID) and trametinib PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for a minimum of 12 cycles and continues until confirmed best response or for up to a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity. Participants then receive dabrafenib PO BID and trametinib PO QD on days 1-28 of each cycle. Cycles repeat every 28 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Participants also undergo ECHO, MRI, and blood sample collection throughout the study and may optionally undergo lumbar puncture for collection of CSF.

Primary Outcome Measure

Rebound rate (RR) [ Time Frame: Up to a maximum of 34 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35233
Girish Dhall, MD
Girish Dhall, MD (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94143
PNOC Operations Office
[email protected]
415-502-1600
[email protected]
877-827-3222
Sabine Mueller, MD, PhD, MAS (PRINCIPAL_INVESTIGATOR)
John Hopkins Medical CenterBaltimoreMaryland21287
Kenneth Cohen, MD, MBA
[email protected]
410-614-5055
Kenneth Cohen, MD, MBA (PRINCIPAL_INVESTIGATOR)
St. Louis Children's Hospital Washington University in St. LouisSt LouisMissouri63110
Mohamed S Abdelbaki, MD
[email protected]
314-286-2790
Mohamed S Abdelbaki, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Daniel Landi, MD
Daniel Landi, MD (PRINCIPAL_INVESTIGATOR)
St. Jude Children's Research HospitalMemphisTennessee38105
Anna Vinitsky, MD
[email protected]
901-595-3300
Amar Gajjar, MD (PRINCIPAL_INVESTIGATOR)

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University of Alabama at Birmingham· Birmingham, ALUniversity of California, San Francisco· San Francisco, CAJohn Hopkins Medical Center· Baltimore, MDSt. Louis Children's Hospital Washington University in St. Louis· St Louis, MODuke University Medical Center· Durham, NCSt. Jude Children's Research Hospital· Memphis, TN

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