RecruitingPhase 2

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

United States21 participantsStarted 2024-07-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 having one or more of the features below: * Gross extrathyroidal extension * FTC with extensive vascular invasion (\> 4), although less likely to have BRAF mutation * PTC with vascular invasion * Advanced nodal disease of (any node \>3 cm, \> 4 nodes, or extra-nodal extension) * BRAF+TERT promoter mutation * Post op thyroglobulin (TG) suggestive of distant metastasis * Distant metastatic sites (only for exploratory arm) * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 * Blood pressure (BP) ≤ 140/90 mm Hg at screening with or without antihypertensive medications and no change in antihypertensive medications within 1 week prior to treatment start * Creatinine clearance ≥ 50 mL/min according to the Cockcroft and Gault formula * Absolute neutrophil count (ANC) ≥ 1.5 x 109/L * Hemoglobin ≥ 9.0 g/dL * Platelet count ≥ 100 x 109/L * Normal blood coagulation f…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patients who achieve excellent or indeterminate response with vemurafenib and cobimetinib treatment prior to radioactive iodine therapy

Timeframe: Up to completion of 6 week vemurafenib and cobimetinib therapy

Trial details

NCT IDNCT06440850

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11-22

View on ClinicalTrials.gov More Thyroid Gland Follicular Carcinoma trials