About this trial
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.
Eligibility criteria
Qualifiers
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)
Disqualifiers
Prior RAI treatment
Prior anti-BRAF, anti-MEK treatment such as sorafenib, dabrafenib, vemurafenib, encorafenib, binimetinib, cobimetinib, trametinib, d selumitinib and other TKIs like, lenvatinib, sunitinib, axitinib, cabozantenib, vandatinib, pazopanib use
Low to intermediate risk differentiated thyroid cancer (DTC) cases (not having the high-risk features as described above)
RAI contraindication
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Cobimetinib
- Computed Tomography
- Diagnostic Imaging
- I-131 Uptake Test
- Iodine I-131
- Magnetic Resonance Imaging
- Positron Emission Tomography
- Recombinant Thyrotropin Alfa
- Ultrasound Imaging
- Vemurafenib
Treatment groups
Sponsors and collaborators
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator