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Long-term follow-up and rollover for children treated with dabrafenib and/or trametinib.

An Open Label, Multi-center Roll-over Study to Assess Long-term Effect in Pediatric Patients Treated With Tafinlar (Dabrafenib) and/or Mekinist (Trametinib)

Phase 4 Interventional Novartis · NCT03975829

This will see if long-term follow-up of children with BRAF V600–mutant brain tumors who were treated with dabrafenib and/or trametinib is safe and helps track lasting effects.

Quick facts

PhasePhase 4
Study typeInterventional
Enrollment165 (estimated)
Ages1 Year to 99 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionstrametinib, chemotherapy
Locations55 sites (Phoenix, Arizona and 54 other locations)
Trial IDNCT03975829 on ClinicalTrials.gov

What this trial studies

This is a rollover design that enrolls pediatric participants from specified Novartis parent trials to continue monitoring after their parent study ends. Eligible participants include children who received dabrafenib and/or trametinib, with a treatment period available for those still on therapy at rollover. Study visits focus on long-term safety assessments, disease status monitoring, and collection of event and survival data at scheduled intervals. Procedures typically include clinical exams, labs and imaging as clinically indicated, and documentation of late adverse events or new therapies.

Who should consider this trial

Good fit: Children (or former pediatric participants) who took part in specified Novartis dabrafenib and/or trametinib parent trials, have provided informed consent, and are willing to comply with scheduled follow-up visits are ideal candidates.

Not a fit: Patients who were not treated with dabrafenib or trametinib in a qualifying Novartis parent study, or who cannot comply with ongoing follow-up visits, are unlikely to receive benefit from this rollover follow-up.

Why it matters

Potential benefit: If successful, this could clarify long-term side effects and benefits of dabrafenib and trametinib in children and improve follow-up care recommendations.

How similar studies have performed: Other trials of dabrafenib and trametinib have demonstrated clinical activity in pediatric BRAF V600–mutant tumors, and rollover long-term follow-up is a commonly used approach to monitor late effects.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

All Subjects:

* Written informed consent, according to local guidelines, signed by the subjects and/or by the parents or legal guardian prior to any study related screening procedures are performed.
* Participation in a Novartis sponsored study such as CTMT212X2101, CDRB436G2201, CDRB436A2102, regardless of current age.
* Parent study (or cohort of parent study) is planned to be closed.
* Subject has demonstrated compliance, as assessed by the investigator, within the parent study protocol requirement(s).
* Willingness and ability to comply with scheduled visits, treatment plans and any other study procedures.

For Subjects Entering the Treatment Period:

* Subject is currently receiving treatment with dabrafenib/trametinib monotherapy or combination within a Novartis Sponsored Drug Development study. Note that subjects who were on the chemotherapy arm of the CDRB436G2201 study are eligible for treatment period of this study only after crossing over into the experimental treatment arm of the CDRB436G2201 study
* In the opinion of the investigator is likely to benefit from continued treatment.

Key Exclusion Criteria:

All Subjects:

\- Subject has participated in a combination trial where dabrafenib and/or trametinib was dispensed in combination with another study medication.

For Subjects Entering the Treatment Period:

* Subject has permanently discontinued from study treatment in the parent protocol due to any reason.
* Treatment with dabrafenib and/or trametinib for the subject's indication is approved for marketing and the appropriate dosage form is commercially available and reimbursed in the local country
* Subject currently has unresolved drug related severe toxicities for which dabrafenib and/or trametinib dosing has been interrupted in the parent study. If the subject should meet criteria to resume treatment on the parent protocol then they may be eligible for treatment in this study.

Other protocol-defined inclusion/exclusion may apply.

Where this trial is running

Phoenix, Arizona and 54 other locations

+5 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.
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Last reviewed 2026-06-13 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.