Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer

Condition(s) studied

Investigational drug(s) / intervention(s)

Dabrafenib: Dabrafenib 150 mg capsule administered orally twice a day (BID)

Trametinib: Trametinib 2 mg tablet administered once a day (QD)

Trametinib Placebo: matching placebo tablet for Trametinib 2 mg will be administered orally once a day (QD)

Dabrafenib placebo: matching placebo capsule for Dabrafenib 150 mg will be administered orally twice a day (BID)

Study summary

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.

Eligibility

Primary outcome measure(s)

• Progression Free Survival (PFS) — From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years
  Progression Free Survival (PFS) was defined as the time from the date of randomization to the date of the first documented progression according to RECIST 1.1 based on Blinded Independent Review Committee (BIRC) assessment, or death due to any cause. The primary analysis was conducted after all patients had either completed a minimum of 16 weeks of treatment or discontinued earlier, and following the occurrence of approximately 95 PFS events (Data cut-off date for the primary analysis was 22 January 2025).

Trial sites (41)

+ 1 more sites — see the full list on the official registry below.