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Long-term study of dabrafenib and trametinib in children and adolescents with cancers that have V600 mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on children and adolescents with cancers that have a specific genetic change called V600 mutation. The study will evaluate the long-term effects of two medications: dabrafenib (also known as DRB436) and trametinib (also known as Mekinist). These medications can be given either separately or in combination. The purpose is to assess the long-term safety of these treatments in young patients.

The medications are available in different forms to make them suitable for children - including tablets that can be dissolved in water, hard capsules, and oral solution powder. The study will monitor how these treatments affect the participants' growth, development, and overall health over time. The medications are taken by mouth daily, and patients will continue receiving the same treatment they were getting in their previous studies.

Throughout the study, doctors will track any health changes and measure important aspects of development such as height, weight, bone growth, and heart function. The study will continue following patients for several years to understand how the treatments affect young patients in the long term.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Your medical condition will be evaluated to confirm the presence of a V600 mutation in your cancer.

    The doctor will review your previous participation in related clinical trials and current treatment status with dabrafenib and/or trametinib.

    Your ability to follow the study schedule and treatment plan will be assessed.

  2. Step 2

    Treatment continuation

    You will continue receiving the same medication you were taking in your previous study:

    Dabrafenib (DRB436) taken by mouth as capsules or dispersible tablets

    Trametinib (Mekinist) taken by mouth as film-coated tablets or oral solution

    The specific dosage will remain the same as in your previous treatment plan

  3. Step 3

    Regular monitoring visits

    Your health will be monitored through regular check-ups that include:

    Recording any side effects or health changes

    Laboratory tests to check your blood values

    Measurement of vital signs

    Tracking of height, weight, and physical development

    Assessment of heart function

    Evaluation of your cancer response to treatment

  4. Step 4

    Long-term follow-up

    The study will continue until May 2026

    Regular assessments will track your growth and development over time

    Your overall health status will be monitored throughout the study period

Who can join the trial?

13 criteria

  • Patient (or parent/legal guardian) must provide written informed consent before any screening procedures
  • Must have previously participated or currently participating in one of these Novartis studies:
    • CTMT212X2101
    • CDRB436G2201
    • CDRB436A2102
    • Must be currently receiving treatment with dabrafenib and/or trametinib (medicines used to treat certain types of cancer)
    • Must have shown good compliance with treatment and study requirements in the previous study
    • Must be willing and able to:
      • Attend scheduled clinic visits
      • Follow treatment plans
      • Complete other study procedures
      • Doctor must believe that continuing treatment will be beneficial for the patient
      • Must not be taking any medications that are not allowed in the study
      • Can be male or female
      • Must be a child or adolescent with cancer that has a specific genetic change called V600 mutation

Who cannot join the trial?

13 criteria

  • History of severe allergic reactions to dabrafenib or trametinib (medications used in the study)
  • Participation in another clinical trial within the last 30 days
  • Presence of active infections requiring treatment
  • Significant heart problems or uncontrolled high blood pressure
  • Severe liver problems (liver function tests more than 3 times above normal)
  • Severe kidney problems (kidney function less than 30% of normal)
  • Pregnancy or breastfeeding
  • Unable to swallow pills
  • Mental conditions that prevent understanding of study requirements
  • Known drug or alcohol abuse
  • Cancer that has spread to the brain, unless previously treated and stable
  • Taking medications that may interfere with the study drugs
  • Any medical condition that the doctor believes makes participation unsafe
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Investigated drugs

Tafinlar (dabrafenib) is a medication used to treat certain types of cancer. It works by blocking a specific protein that can cause cancer cells to grow. This medication is being studied for long-term use in children who have certain types of cancer. Mekinist (trametinib) is another cancer medication that works by targeting a different protein involved in cancer cell growth. Like Tafinlar, it is being studied for long-term treatment in pediatric patients with cancer. The trial also studies the combination of Tafinlar and Mekinist together, as these medications can work in partnership to fight cancer cells through different mechanisms. This combination approach may provide better results than using either medication alone.

What is already known about the treatment

  • Tafinlar (dabrafenib)

    An oral medication administered in capsule form that belongs to the class of targeted cancer therapies known as BRAF inhibitors. This drug specifically targets cancers that have a V600 mutation in the BRAF gene, working at the molecular level by blocking the abnormal BRAF protein that drives cancer growth. It is primarily used in the treatment of certain types of cancer in children and adolescents, particularly those that have been confirmed to carry the BRAF V600 mutation, and is often used in combination therapy with Mekinist for enhanced effectiveness.

  • Mekinist (trametinib)

    An oral medication taken in tablet form that belongs to the MEK inhibitor class of targeted cancer therapies. This medication works by blocking the MEK protein, which is part of the same signaling pathway as BRAF, helping to slow or stop the growth of cancer cells. It is specifically indicated for treating young patients with cancers that harbor the V600 mutation, and is frequently prescribed in combination with Tafinlar to provide a dual-blocking approach to cancer treatment, potentially improving outcomes compared to single-agent therapy.

Investigated diseases

  • Cancer with V600 mutation

    A specific type of cancer characterized by a mutation in the BRAF gene at position V600. This genetic alteration causes cells to grow and divide uncontrollably. The mutation can occur in various types of cancer, particularly affecting children and adolescents. The condition involves changes in normal cell growth patterns, leading to the formation of tumors. The disease progresses when mutated cells continue to multiply and potentially spread to other parts of the body.

  • Rare Cancer

    A form of cancer that affects a limited number of people compared to more common cancer types. This condition occurs in a small percentage of the population, making it less frequently encountered in medical practice. The disease develops when specific cell types in the body begin to grow abnormally. These cancers can appear in various parts of the body and may have unique growth patterns.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509276-42-00Protocol codeCDRB436G2401Estimated enrolment166 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).