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

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.

Timeline

Start

2021-11-15

Primary completion

2025-01-22

Completion

2027-05-25

Publications

• Gao M, Park YJ, Lin CC, Krzyzanowska MK, Li Z, Tsai HJ, Shi F, Qin J, Choong SH, Lin Y, Zhang Y, Kang JH, Hoff AO, Tan M, Roughton M, Paul M, Wirth LJ. Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Jul 13:S1470-2045(26)00133-6. doi: 10.1016/S1470-2045(26)00133-6. Online ahead of print.

Drugs

Indications