Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
NCT06440850 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-02-02
Summary
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.
Conditions
- Thyroid Gland Follicular Carcinoma
- Thyroid Gland Oncocytic Carcinoma
- Thyroid Gland Papillary Carcinoma
Interventions
- PROCEDURE
-
Biospecimen Collection
Undergo blood sample collection
- DRUG
-
Cobimetinib
Given PO
- PROCEDURE
-
Computed Tomography
Undergo CT scan
- PROCEDURE
-
Diagnostic Imaging
Undergo I-123 diagnostic scan
- PROCEDURE
-
I-131 Uptake Test
Undergo I-131 whole body scan
- RADIATION
-
Iodine I-131
Given PO
- PROCEDURE
-
Magnetic Resonance Imaging
Undergo MRI
- PROCEDURE
-
Positron Emission Tomography
Undergo PET scan
- BIOLOGICAL
-
Recombinant Thyrotropin Alfa
Given IM
- PROCEDURE
-
Ultrasound Imaging
Undergo neck ultrasound
- DRUG
-
Vemurafenib
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Sasan Fazeli · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-15
- Primary Completion
- 2026-11-22
- Completion
- 2026-11-22
- FDA Drug
- Yes
Countries
- United States
Study Locations
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