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Monitoring the use of Tafinlar and Mekinist in patients with specific tumors

Observational Study to Assess Safety and Effectiveness of Dabrafenib and Trametinib in Patients With BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid Tumor

Observational Novartis · NCT06262919

This study is testing how well the drugs Tafinlar and Mekinist work and how safe they are for adults and kids with certain hard-to-treat tumors.

Quick facts

Study typeObservational
Enrollment110 (estimated)
Ages6 Years to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionstrametinib
Locations68 sites (Nagakute, Aichi-ken and 67 other locations)
Trial IDNCT06262919 on ClinicalTrials.gov

What this trial studies

This observational study aims to collect data on the effectiveness and safety of Tafinlar (dabrafenib) and Mekinist (trametinib) in patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors. It will involve a multicenter approach where patients will be registered in a central system and monitored over a specified period. The study will include both adult and pediatric patients, with adults observed for one year and pediatric patients for up to eight years to gather long-term data. The goal is to assess the real-world outcomes of these treatments in a clinical setting.

Who should consider this trial

Good fit: Ideal candidates include patients with BRAF V600E mutation-positive unresectable advanced or recurrent solid tumors who have consented to participate in the surveillance.

Not a fit: Patients with BRAF-mutation-positive malignant melanoma, non-small cell lung cancer, or hairy cell leukemia will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term effectiveness and safety of Tafinlar and Mekinist for patients with specific advanced tumors.

How similar studies have performed: Other studies have shown success with similar observational approaches in monitoring drug effectiveness, making this a potentially valuable addition to existing knowledge.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients who have given written consent to cooperate in this surveillance
2. For patients aged \< 18 years at the start of treatment with the product, their legally authorized representative must have given written informed consent for cooperation in this surveillance prior to patient enrollment.
3. Patients who start treatment with the product for BRAF-mutation-positive advanced/recurrent solid tumors (excluding colorectal cancer) after the approval of additional indications

Exclusion Criteria:

1. Patients who have received or are receiving a product containing the same ingredient as the product in any other study or research than this surveillance
2. Patients with BRAF-mutation-positive malignant melanoma
3. Patients with BRAF-mutation-positive non-small cell lung cancer
4. Patients with BRAF-mutation-positive hairy cell leukemia

Where this trial is running

Nagakute, Aichi-ken and 67 other locations

+18 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions BRAF V600E Mutation-positive Unresectable Advanced or Recurrent Solid TumorTafinlardabrafenibMekinisttrametinibBRAF V600E mutation-positive unresectable advancedsolid tumorJapan
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.