About the study

150 adults 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 will enter in the trial. Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1versus2) and prior lenvatinib treatment (yes versus no)

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

1. Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure
2. Male or female >= 18 years of age at the time of informed consent
3. Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid cancer
4. Radio active iodine refractory disease
5. BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result
6. Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy
7. Eastern Cooperative Oncology Group performance status >= 2
8. At least one measurable lesion as defined by RECIST 1.1

Exclusion criteria

1. Anaplastic or medullary carcinoma of the Tyroid
2. Previous treatment with BRAF inhibitor and/or MEK inhibitor
3. Concomitant RET Fusion Positive Thyroid cancer
4. Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization
5. Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeks before randomization
6. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization
7. A history or current evidence/risk of retinal vein occlusion or central serous retinopathy

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.