The purpose of this study is to assess the efficacy and safety of dabrafenib in
combination with trametinib for treating adult patients with locally advanced or
metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are
refractory to radioactive iodine (RAI) therapy and have experienced disease progression
following one or two prior VEGFR-targeted treatments.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04940052.
This is a global, multicenter, randomized, double-blind, placebo-controlled phase III
study to evaluate the efficacy and safety of dabrafenib plus trametinib in adult patients
with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid
carcinoma who are refractory to radioactive iodine and have progressed following prior
VEGFR targeted therapy. The scientific objective guiding the primary estimand is based on
the Progression Free Survival (PFS) as per BIRC assessment using RECIST 1.1 criteria.
Patients randomized in the placebo arm for whom disease progression as per RECIST 1.1 is
confirmed by Blinded Independent Review Committee (BIRC) and who meet the eligibility
criteria outlined in the study protocol will be given the option to crossover to the
open-label dabrafenib plus trametinib treatment.
Lead OrganizationNovartis Pharmaceuticals Corporation
