Actively Recruiting
Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
Led by City of Hope Medical Center · Updated on 2026-02-02
21
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Vemurafenib and Cobimetinib for the Treatment of Patients With High Risk Differentiated Thyroid Carcinoma With BRAFV600E Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Willing to be followed for about 14 months
- Male or female aged 18 years or older
- Diagnosed with thyroid carcinoma of follicular origin (papillary, follicular, or Hurthle cell)
- Confirmed BRAFV600E mutation from prior analysis or tumor biopsy
- High risk for recurrence per American Thyroid Association guidelines, including features such as gross extrathyroidal extension, extensive vascular invasion, advanced nodal disease, BRAF+TERT promoter mutation, post-op thyroglobulin suggesting distant metastasis, or distant metastatic sites
- ECOG performance status of 0 to 1
- Blood pressure at or below 140/90 mm Hg with stable antihypertensive treatment
- Creatinine clearance of at least 50 mL/min
- Absolute neutrophil count of 1.5 x 10^9/L or higher
- Hemoglobin of 9.0 g/dL or higher
- Platelet count of 100 x 10^9/L or higher
- Normal blood coagulation with INR of 1.5 or less
- Bilirubin at or below 1.5 times upper limit of normal except for certain conditions
- ALP, ALT, and AST at or below 3 times upper limit of normal (5 times if liver metastases present)
- Negative pregnancy test within 7 days before first study treatment for women of childbearing potential
- Agreement to use effective birth control methods for women and men of childbearing potential from 3 months before screening through 1 year follow-up
- Non-English speakers and adults lacking capacity to consent are eligible
You will not qualify if you...
- Prior radioactive iodine treatment
- Prior treatment with anti-BRAF, anti-MEK therapies or certain tyrosine kinase inhibitors
- Low to intermediate risk differentiated thyroid cancer without high-risk features
- Contraindication to radioactive iodine therapy
- Undifferentiated or medullary thyroid carcinoma
- Major surgery within 4 weeks before starting treatment
- Significant proteinuria exceeding 1 g/24 h
- Need for locoregional treatments such as surgery, radiation, or thermoablation at enrollment
- External beam radiation for thyroid cancer within 4 weeks before treatment
- Conditions affecting drug absorption
- Recent history of severe heart conditions or uncontrolled hypertension
- QTc interval of 480 msec or more on ECG
- Active bleeding or coagulopathy
- Active infection requiring systemic therapy
- Active malignancy other than certain treated skin or cervical cancers within past 24 months
- Medical or psychosocial conditions that could impair safety or study completion
- Pregnant or breastfeeding females
- Recent injection of radio-contrast agent within 12 weeks
- History of retinal vein occlusion or serious retinopathy
- Known allergy to study drugs or their ingredients
- Noncompliance or inability to follow study procedures as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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