Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center

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

21 Participants
are divided into 1 treatment group

Sponsors and collaborators

City of Hope Medical Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator