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New hope for rare cancers: drug combo targets BRAF mutation

NCT ID NCT05868629

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a combination of two targeted drugs, dabrafenib and trametinib, in people with rare solid tumors that have a specific genetic change called BRAF V600E. The goal is to see how well the drugs shrink or control the tumors. The study includes both children (age 1 and older) and adults whose tumors cannot be removed by surgery or have spread to other parts of the body.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Study participants diagnosed with a rare BRAF V600E mutation-positive unresectable or metastatic solid tumor, 1 year and older excluding patients with melanoma, Non-Small Cell Lung Cancer, Colorectal Cancer, Anaplastic Thyroid Cancer, Biliary Tract Cancer and glioma, who will be treated with dabrafenib and trametinib.

Ages

1 year to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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;

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Conditions

The condition(s) this trial relates to.

hereditary sensory and autonomic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rare unresectable or metastatic BRAF V600E mutation-positive solid tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke Clinical Research Institute

    RECRUITING

    Durham, North Carolina, 27704, United States

  • El Paso Texas Oncology

    RECRUITING

    El Paso, Texas, 79902, United States

  • Johns Hopkins University

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Lundquist Inst BioMed at Harbor

    RECRUITING

    Torrance, California, 90509-2910, United States

  • Oncology Hematology Care Inc

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Rocky Mountain Cancer Centers

    RECRUITING

    Denver, Colorado, 80218, United States

  • Sarah Cannon Research Institute

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology San Antonio

    RECRUITING

    San Antonio, Texas, 78258, United States