Pediatric Long-Term Follow-up and Rollover Study
A roll-over study to assess long-term effect in pediatric patients treated with dabrafenib and/or trametinib.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
The study team can explain what participation involves.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 27, 2026 · Source: ClinicalTrials.gov
The study is underway but is not accepting new participants.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 4
- Sponsor
- Novartis Pharmaceuticals
- Interventions being studied
- Drug: dabrafenib; Drug: trametinib
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Key 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
- 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Phoenix Children s HospitalPhoenix, Arizona
- Childrens National HospitalWashington D.C., District of Columbia
- Nicklaus Childrens HospitalMiami, Florida
- Indiana Uni School of MedicineIndianapolis, Indiana
- Johns Hopkins HospitalBaltimore, Maryland
- Dana Farber Cancer InstituteBoston, Massachusetts
- University of MinnesotaMinneapolis, Minnesota
- Memorial Sloan Kettering Cancer CtrNew York, New York
- Cinn Children Hosp Medical CenterCincinnati, Ohio
- St Jude Childrens Research HospitalMemphis, Tennessee
- Texas Childrens HospitalHouston, Texas
- Novartis Investigative SiteCABA, Buenos Aires
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 27, 2026. Always confirm current availability with the study team.