Overview
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (1 years or older) and adult study participants with rare BRAF V600E mutation-positive unresectable or metastatic solid tumors for whom a decision has already been made to be treated with dabrafenib and trametinib, irrespective of the trial participation.
Eligibility
Inclusion Criteria:
- Study participant with a BRAF V600E mutation-positive solid tumor as confirmed by a local laboratory test;
- At least 1 measurable lesion as defined by RECIST v1.1 per local review;
- Study participant previously not treated with dabrafenib and/or trametinib. Study participants who received dabrafenib and trametinib in the past for the treatment of other malignancies are eligible if treatment has been discontinued for greater than 1 year;
- Ability to provide scans for central imaging review
Exclusion Criteria:
- Those with the following tumor types: melanoma, NSCLC, ATC, BTC, glioma and CRC;
- Study participants who have contraindication to receive dabrafenib and/ or trametinib according to the local label;