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Long-Term Safety Study of Dabrafenib Mesylate and Trametinib Dimethyl Sulfoxide for Patients Benefiting from Previous Treatment in Multiple Indications

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What is this trial about?

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

This clinical trial is focused on patients with various types of cancer who are currently benefiting from treatment with the medications dabrafenib and/or trametinib. These medications are used to treat certain types of cancer by targeting specific proteins in cancer cells, which can help slow down or stop the growth of the cancer. The study aims to provide continued access to these treatments for patients who have been part of previous studies sponsored by Novartis or GSK and are still experiencing benefits from the treatment.

The purpose of the study is to assess the long-term safety of these medications. Participants will continue to receive their current treatment, either as a single medication or in combination, depending on what they were receiving in the previous study. The study will monitor the occurrence of any side effects or adverse events to ensure the ongoing safety of the treatment. Patients will have regular check-ups with their healthcare providers to evaluate their health and the effectiveness of the treatment.

This study is designed for patients who have already been receiving dabrafenib and/or trametinib and have shown compliance with the treatment plan. The study will continue until the end of 2027, allowing patients to maintain their treatment regimen under the supervision of their healthcare team. The goal is to ensure that patients who are benefiting from these medications can continue to do so safely over a longer period.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must provide written informed consent. This consent confirms understanding and agreement to participate in the study.

    The patient must be currently receiving treatment with either dabrafenib or trametinib, or both, as part of a previous study sponsored by Novartis or GSK.

  2. Step 2

    Treatment continuation

    The patient will continue taking the medications dabrafenib and/or trametinib as prescribed. These medications are taken orally.

    Dabrafenib is provided in the form of a hard capsule, while trametinib is provided as a film-coated tablet.

  3. Step 3

    Scheduled visits

    The patient must attend scheduled visits as part of the study requirements. These visits are necessary to monitor the patient's health and the effects of the medication.

    During these visits, the investigator will assess the patient's clinical benefit from the treatment.

  4. Step 4

    Safety monitoring

    The primary objective of the study is to evaluate the long-term safety of the treatment. This involves monitoring for any adverse events (AEs) or serious adverse events (SAEs).

    The frequency and severity of these events will be recorded and assessed.

  5. Step 5

    Study duration

    The study is estimated to conclude by December 21, 2027. The patient will continue to receive treatment and attend visits until the study ends or until the investigator determines that the patient no longer benefits from the treatment.

Who can join the trial?

6 criteria

  • The patient is currently receiving treatment with **dabrafenib** and/or **trametinib** either alone or together in a study sponsored by Novartis or former GSK, which has met the main study goals. **Dabrafenib** and **trametinib** are medications used to treat certain types of cancer.
  • The study doctor believes the patient would benefit from continuing the treatment.
  • The patient has followed the rules and requirements of the original study, as checked by the study doctor.
  • The patient is willing and able to attend scheduled visits, follow treatment plans, and participate in other study procedures.
  • The patient has provided written informed consent before joining the new study and receiving the study medication. If the patient cannot provide written consent, it must be formally documented and witnessed, preferably by an independent trusted person.
  • The patient does not need treatment with medications that are not allowed during the study.

Who cannot join the trial?

9 criteria

  • Patients who are not within the specified age range for the study.
  • Patients who have medical conditions that are not suitable for the study.
  • Patients who are part of a vulnerable population that the study cannot safely include.
  • Patients who have experienced certain side effects or serious side effects in the past that may affect their safety in the study.
  • Patients who are not able to follow the study procedures or instructions.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a history of certain medical conditions that could interfere with the study results.
  • Patients who are pregnant or breastfeeding, as the study may not be safe for them.
  • Patients who have allergies or reactions to the study medication or similar medications.
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Investigated drugs

  • Tafinlar

    is a medication used in this trial to help treat certain types of cancer. It works by targeting and blocking specific proteins in cancer cells, which can slow down or stop the growth of the cancer.

  • Mekinist

    is another medication involved in the trial. It is used alongside Tafinlar to treat cancer by inhibiting different proteins that are involved in the growth and spread of cancer cells. This combination aims to improve the effectiveness of the treatment.

What is already known about the treatment

  • Dabrafenib

    Dabrafenib is administered orally in the form of capsules. It is currently used in medicine for treating certain types of cancer, particularly those with specific genetic mutations. The main therapeutic indication for dabrafenib is the treatment of melanoma and other cancers with BRAF V600E mutations. At the molecular level, dabrafenib works by inhibiting the BRAF protein kinase, which is involved in cell growth and division. It is classified as a BRAF inhibitor in pharmacology.

  • Trametinib

    Trametinib is taken orally as a tablet. It is recognized in medical literature for its role in treating cancers with specific genetic profiles, often in combination with other medications. The primary therapeutic use of trametinib is for melanoma and other cancers with BRAF V600E or V600K mutations. Its mechanism of action involves inhibiting the MEK protein, which is part of a pathway that promotes cancer cell growth. Trametinib is classified as a MEK inhibitor in pharmacological terms.

Investigated diseases

Multiple Sclerosis – Multiple sclerosis is a chronic disease that affects the central nervous system, particularly the brain and spinal cord. It involves an abnormal immune response that damages the protective covering of nerve fibers, leading to communication problems between the brain and the rest of the body. Symptoms can vary widely, including fatigue, difficulty walking, numbness, and muscle weakness. The disease often progresses with periods of relapses and remissions, but some individuals may experience a steady worsening of symptoms over time. The exact cause of multiple sclerosis is unknown, but it is believed to involve genetic and environmental factors.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509318-13-00Protocol codeCDRB436X2X02BEstimated enrolment113 patientsSponsorNovartis Pharma AG

sourced from the EU Clinical Trials Register and site verification

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