Study Description
This study is a phase IV, pragmatic single-arm prospective, open label study in pediatric (6 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.
Interventions
Non-investigational
Eligibility Criteria
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;
Duke Clinical Research Institute
Recruiting
Durham,North Carolina,27704,United States
John Strickler
Vandana Turaga
Oncology Hematology Care Inc
Recruiting
Cincinnati,Ohio,45242,United States
Jayadev Mettu
Jyvona White
Johns Hopkins University
Recruiting
Washington,District of Columbia,20016,United States
Mahlet Atnafu
Michael Pishvaian
Sarah Cannon Research Institute
Recruiting
Nashville,Tennessee,37203,United States
Meredith Ann McKean
Stina Medlen
Worldwide Contacts
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