City of Hope Medical Center
This phase II trial tests how well vemurafenib and cobimetinib work in treating patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy. Vemurafenib and cobimetinib are used in patients whose cancer has a mutated (changed) form of a gene called BRAF. They are in a class of medications called kinase inhibitors. They work by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving vemurafenib and cobimetinib may work better to treat patients with high risk differentiated thyroid carcinoma with BRAFV600E mutation, in preparation for radioactive iodine therapy.
PRIMARY OBJECTIVE: I. The proportion of BRAF mutated high-risk differentiated thyroid carcinoma patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to initial radioactive iodine (RAI) therapy as defined by American Thyroid Association guideline. SECONDARY OBJECTIVES: I. The proportion of patients who had significant change on their I-123 scan before and after the targeted therapy. II. To evaluate the safety and tolerability as determined by adverse events related to vemurafenib and cobimetinib combination therapy. III. To evaluate the…
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Willingness to be followed for about 14 months * Males or females aged ≥ 18 years at the time of informed consent * Patients with thyroid carcinoma of follicular origin (papillary, follicular or Hurthle cell) * Known positive BRAFV600E mutation (determined on a previous analysis and/or on a representative formalin-fixed paraffin embedded (FFPE) tumor samples or on a biopsy sample) * High risk for recurrence according to the American Thyroid Association (ATA) guideline defined as hav…
Undergo blood sample collection
Given PO
Undergo CT scan
Undergo I-123 diagnostic scan
Undergo I-131 whole body scan
Given PO
Undergo MRI
Undergo PET scan
Given IM
Undergo neck ultrasound
Given PO
Arctuva estimate
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