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Observational Study of Dabrafenib Plus Trametinib for Rare BRAF V600E Solid Tumors

This study is looking at how well dabrafenib and trametinib work together in people with rare solid tumors that have a specific genetic change called BRAF V600E. You might be able to join if you have one of these tumors, it can't be removed by surgery, or it has spread, and you haven't been treated with these drugs before. This study is for both children (age 1 and older) and adults. Doctors will be checking to see if your tumor shrinks or stops growing (Overall Response Rate) over about four years. The study is currently unclear on its recruitment status.

Study design
This is an observational study, meaning researchers will watch how patients respond to treatment they are already receiving. It's a single-arm study, meaning everyone receives the same treatment, and it's open-label, so both you and your doctor will know what treatment you are getting. The study plans to include about 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will follow participants to measure the Overall Response Rate for approximately 4 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05868629

Clinical Study To Further Evaluate The Efficacy Of Dabrafenib Plus Trametinib In Patients With Rare BRAF V600E Mutation-Positive Unresectable or Metastatic Solid Tumors

Recruiting
Not specifiedAges 1+Observational
Novartis Pharmaceuticals
~40 participants
Updated 2026-04-01 on ClinicalTrials.gov
What's tested:Non-investigational

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Response Rate (ORR)
Measured over Approximately 4 years

Conditions

Rare Unresectable or Metastatic BRAF V600E Mutation-positive Solid Tumors

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Solid Neoplasm

NCT05868629

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Duke Clinical Research Institute

    Durham, North Carolinastudy coordinator listed

    Recruiting

  • El Paso Texas Oncology

    El Paso, Texasstudy coordinator listed

    Recruiting

  • Johns Hopkins University

    Washington D.C., District of Columbiastudy coordinator listed

    Recruiting

  • Lundquist Inst BioMed at Harbor

    Torrance, Californiastudy coordinator listed

    Recruiting

  • Oncology Hematology Care Inc

    Cincinnati, Ohiostudy coordinator listed

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Coloradostudy coordinator listed

    Recruiting

  • Sarah Cannon Research Institute

    Nashville, Tennesseestudy coordinator listed

    Recruiting

  • Texas Oncology San Antonio

    San Antonio, Texasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Novartis Pharmaceuticals · STUDY_DIRECTOR · Novartis Pharmaceuticals

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Inclusion

Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
At least 1 measurable lesion as defined by RECIST v1.1 per local review;
Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
Ability to provide scans for central imaging review

Exclusion

Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;

What this trial measures

  • Overall Response Rate (ORR)Approximately 4 years

    Proportion of study participants with a best overall confirmed Complete Response (CR) or Partial Response (PR) by independent central review according to RECIST v1.1 or other relevant response criteria.