RecruitingPhase 3NCT06475989

Study of Targeted Therapy vs. Chemotherapy in Patients With Thyroid Cancer

A Randomized Phase III Study of BRAF-Targeted Therapy vs Cabozantinib in RAI-Refractory Differentiated Thyroid Cancer With BRAF V600Em

Sponsor

ECOG-ACRIN Cancer Research Group

Enrollment

264 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Refractory Differentiated Thyroid Gland Carcinoma

Summary

This phase III trial compares the effect of cabozantinib versus combination dabrafenib and trametinib for the treatment of patients with differentiated thyroid cancer that does not respond to treatment (refractory) and which expresses a BRAF V600E mutation. Cabozantinib is in a class of medications called receptor tyrosine kinase inhibitors. It binds to and blocks the action of several enzymes which are often over-expressed in a variety of tumor cell types. This may help stop or slow the growth of tumor cells and blood vessels the tumor needs to survive. Dabrafenib is an enzyme inhibitor that binds to and inhibits the activity of a protein called B-raf, which may inhibit the proliferation of tumor cells which contain a mutated BRAF gene. Trametinib is also an enzyme inhibitor. It binds to and inhibits the activity of proteins called MEK 1 and 2, which play a key role in activating pathways that regulate cell growth. This may inhibit the growth of tumor cells mediated by these pathways. The usual approach for patients with thyroid cancer is targeted therapy with dabrafenib and trametinib. This trial may help researchers decide which treatment option (cabozantinib alone or dabrafenib in combination with trametinib) is safer and/or more effective in treating patients with refractory BRAF V600E-mutated differentiated thyroid cancer.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatment strategies for differentiated thyroid cancer with a specific mutation called BRAF V600E that has stopped responding to standard treatments. One approach uses targeted therapy drugs (dabrafenib + trametinib, which block the BRAF/MEK cancer signaling pathway), and the other uses traditional chemotherapy. The goal is to find out which approach works better. **You may be eligible if...** - You are 18 years old or older - You have differentiated thyroid cancer (papillary or follicular type) with a BRAF V600E mutation confirmed by testing - Your cancer has progressed despite prior treatment with radioactive iodine and at least one VEGFR-targeting drug (such as lenvatinib or sorafenib) - Your cancer has at least one measurable area on imaging - You are generally healthy enough to participate **You may NOT be eligible if...** - You have had prior treatment with cabozantinib or any BRAF-targeted therapy for thyroid cancer - You have uncontrolled high blood pressure, congestive heart failure, or had a stroke or heart attack in the past 6 months - You have a history of significant gastrointestinal problems or bleeding - 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

DRUGCabozantinib

Given PO

PROCEDUREComputed Tomography

Undergo CT scan

DRUGDabrafenib

Given PO

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

OTHERQuestionnaire Administration

Ancillary study

DRUGTrametinib

Given PO

Locations(112)

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Smilow Cancer Hospital-Derby Care Center

Derby, Connecticut, United States

Smilow Cancer Hospital Care Center-Fairfield

Fairfield, Connecticut, United States

Smilow Cancer Hospital Care Center at Glastonbury

Glastonbury, Connecticut, United States

Smilow Cancer Hospital Care Center at Greenwich

Greenwich, Connecticut, United States

Smilow Cancer Hospital Care Center - Guilford

Guilford, Connecticut, United States

Smilow Cancer Hospital Care Center at Saint Francis

Hartford, Connecticut, United States

Smilow Cancer Center/Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Yale-New Haven Hospital North Haven Medical Center

North Haven, Connecticut, United States

Smilow Cancer Hospital Care Center at Long Ridge

Stamford, Connecticut, United States

Smilow Cancer Hospital-Torrington Care Center

Torrington, Connecticut, United States

Smilow Cancer Hospital Care Center-Trumbull

Trumbull, Connecticut, United States

Smilow Cancer Hospital-Waterbury Care Center

Waterbury, Connecticut, United States

Smilow Cancer Hospital Care Center - Waterford

Waterford, Connecticut, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Saint Mary's Hospital

Centralia, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Northwestern Medicine Cancer Center Kishwaukee

DeKalb, Illinois, United States

Northwestern Medicine Cancer Center Delnor

Geneva, Illinois, United States

Northwestern Medicine Glenview Outpatient Center

Glenview, Illinois, United States

Northwestern Medicine Grayslake Outpatient Center

Grayslake, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Northwestern Medicine Orland Park

Orland Park, Illinois, United States

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Mercy Hospital

Cedar Rapids, Iowa, United States

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Central Care Cancer Center - Garden City

Garden City, Kansas, United States

Central Care Cancer Center - Great Bend

Great Bend, Kansas, United States

Sanford Joe Lueken Cancer Center

Bemidji, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Cambridge Medical Center

Cambridge, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Sanford Thief River Falls Medical Center

Thief River Falls, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Sanford Cancer Center Worthington

Worthington, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Cox Cancer Center Branson

Branson, Missouri, United States

Southeast Cancer Center

Cape Girardeau, Missouri, United States

Freeman Health System

Joplin, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

Delbert Day Cancer Institute at PCRMC

Rolla, Missouri, United States

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, United States

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

CoxHealth South Hospital

Springfield, Missouri, United States

Saint Louis Cancer and Breast Institute-South City

St Louis, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Mercy Hospital Washington

Washington, Missouri, United States

Community Hospital of Anaconda

Anaconda, Montana, United States

Billings Clinic Cancer Center

Billings, Montana, United States

Bozeman Health Deaconess Hospital

Bozeman, Montana, United States

Benefis Sletten Cancer Institute

Great Falls, Montana, United States

Great Falls Clinic

Great Falls, Montana, United States

Logan Health Medical Center

Kalispell, Montana, United States

Community Medical Center

Missoula, Montana, United States

Sanford Bismarck Medical Center

Bismarck, North Dakota, United States

Sanford South University Medical Center