RecruitingPhase 2NCT06440850

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

A Pilot Clinical Trial of Vemurafenib and Cobimetinib as a Redifferentiation Strategy in High-Risk, Radioactive Iodine (RAI) Naïve, BRAFV600E Mutated Differentiated Thyroid Carcinoma Patients Undergoing Initial RAI Therapy


Sponsor

City of Hope Medical Center

Enrollment

21 participants

Start Date

Jul 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of two targeted drugs — vemurafenib and cobimetinib — for people with high-risk differentiated thyroid cancer that has a specific gene mutation called BRAFV600E. This mutation causes cells to grow uncontrollably, and these drugs are designed to block that pathway. **You may be eligible if...** - You are 18 years old or older - You have thyroid cancer (papillary, follicular, or similar type) confirmed to have the BRAFV600E mutation - Your cancer is high-risk and has not responded to standard treatments - You have adequate organ function (heart, liver, kidneys) **You may NOT be eligible if...** - You do not have the BRAFV600E mutation - You have had prior treatment with BRAF or MEK inhibitors - You have significant heart problems or other serious conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

DRUGCobimetinib

Given PO

PROCEDUREComputed Tomography

Undergo CT scan

PROCEDUREDiagnostic Imaging

Undergo I-123 diagnostic scan

PROCEDUREI-131 Uptake Test

Undergo I-131 whole body scan

RADIATIONIodine I-131

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREPositron Emission Tomography

Undergo PET scan

BIOLOGICALRecombinant Thyrotropin Alfa

Given IM

PROCEDUREUltrasound Imaging

Undergo neck ultrasound

DRUGVemurafenib

Given PO


Locations(1)

City of Hope Medical Center

Duarte, California, United States

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NCT06440850


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