Phase III Study Comparing Cabozantinib and Dabrafenib Plus Trametinib for Treating BRAF V600E Mutated Refractory Differentiated Thyroid Cancer

What this Trial Is About

Researchers are evaluating treatments for patients with differentiated thyroid cancer that does not respond to prior therapy and has a specific BRAF V600E mutation. This phase III trial compares the effects of cabozantinib versus a combination of dabrafenib and trametinib. Cabozantinib works by blocking enzymes involved in tumor growth, while dabrafenib and trametinib target proteins that regulate cell growth and tumor proliferation. The study aims to determine which treatment is safer and more effective for this type of thyroid cancer. Participants are randomly assigned to one of two groups. One group receives dabrafenib twice daily and trametinib once daily in 28-day cycles, while the other group receives cabozantinib once daily in similar 28-day cycles. Treatment continues unless the disease progresses or unacceptable side effects occur. Throughout the study, patients undergo CT scans, blood sample collections, and may have MRI scans. After treatment ends, participants are followed every 3 months for 2 years and then every 6 months for up to 5 years. During the trial, participants will be monitored with imaging tests and laboratory evaluations to assess tumor progression and treatment effects. Questionnaires will also be used to evaluate quality of life and tolerability. Researchers will measure progression-free survival, response rates, overall survival, duration of response, and safety. The study includes ongoing assessments of adverse events at specified intervals. Participants will be followed long-term to monitor outcomes related to their thyroid cancer and treatment.

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