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

Korábbi kezelés

• 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 (including investigational 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 other radiation therapy within 4 weeks before randomization

Egyéb

• Anaplastic or medullary carcinoma of the thyroid
• A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
  • Other inclusion/exclusion criteria may apply.

• Signed informed consent
• Male or female ≥ 18 years of age at time of informed consent
• Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated 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.