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

Key Inclusion Criteria:

• Signed informed consent

• Male or female ≥ 18 years of age at time of informed consent

• Histologically or cytologically confirmed diagnosis of advanced/metastaticdifferentiated thyroid carcinoma

• Radioactive-iodine refractory disease

• BRAF V600E mutation-positive tumor sample as per central laboratory result

• Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapies

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

• At least one measurable lesion as defined by RECIST v1.1.

Key Exclusion Criteria:

• Anaplastic or medullary carcinoma of the thyroid

• Previous treatment with a BRAF inhibitor and/or a MEK inhibitor

• Concomitant RET Fusion-Positive Thyroid Cancer

• Treatment with any type of small molecule kinase inhibitor (includinginvestigational kinase inhibitor) within 2 weeks before randomization

• Treatment with any type of anticancer antibody (including investigational antibody)or systemic chemotherapy within 4 weeks before randomization

• Treatment with radiation therapy for bone metastasis within 2 weeks or any otherradiation therapy within 4 weeks before randomization

• A history or current evidence/risk of retinal vein occlusion (RVO) or central serousretinopathy

Other inclusion/exclusion criteria may apply.