RecruitingBRAF NP_004324.2:p.V600EBRAF V600K Mutation PresentThyroid Gland Anaplastic Carcinoma
Dabrafenib, Trametinib, and IMRT in Treating Patients With BRAF Mutated Anaplastic Thyroid Cancer
Eligible age
18+ yrs
Accepts
All genders
Locations
3 states
Healthy volunteers
No
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About this study
This trial studies how well dabrafenib, trametinib, and intensity modulated radiation therapy (IMRT) work together in treating patients with BRAF mutated anaplastic thyroid cancer. Dabrafenib and trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy beams to kill tumor cells and shrink tumors. Giving dabrafenib, trametinib, and IMRT together may kill more tumor cells.
Sponsor: City of Hope Medical Center
You may qualify if…
- ✓ Pathologic (histologic or cytologic) diagnosis of anaplastic thyroid cancer (a diagnosis that is noted to be ?consistent with anaplastic thyroid cancer? with the presence of a thyroid mass is acceptable; pathology showing additional types of thyroid cancer is allowed)
- ✓ Note: Tissue collection for central review is mandatory, but central review is not required for eligibility. Due to the aggressiveness of this disease, treatment will be started prior to central review.
- ✓ Presence of BRAF mutation (V600E or V600K) in tumor tissue.
- ✓ Eastern Cooperative Oncology Group (ECOG) performance status \< 2.
- ✓ Absolute neutrophil count \> 1,000/mcL.
- ✓ Hemoglobin \>= 9.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin \[Hgb\] \>= 9.0 g/dl is acceptable).
- ✓ Platelets \> 75,000/mcL.
- ✓ Total bilirubin \< 1.5 x institutional upper limit of normal (unless due to Gilbert?s disease).
You may not qualify if…
- ✕ Patients with resectable stage IVA anaplastic thyroid cancer who are candidates for surgery and wish to proceed with surgery.
- ✕ Patients who have had external beam radiotherapy to neck or chest for cancer that would result in overlap of radiation therapy fields.
- ✕ Patients who have had cytotoxic chemotherapy, stereotactic brain radiation or external beam radiation within 2 weeks prior to study treatment initiation.
- ✕ Patients who have had oral multikinase inhibitors within 1 week prior to study treatment initiation.
- ✕ Patients that have not recovered from adverse events related to prior therapy for cancer to Common Terminology Criteria for Adverse Events (CTCAE) 4.03 grade 2 or less except for alopecia.
- ✕ Patients previously treated with potent BRAF inhibitor or MEK inhibitor. Previous treatment with sorafenib is permitted.
- ✕ Patients that are receiving any other investigational agent.
- ✕ Patients that are currently taking any prohibitive medication.
Where it's recruiting
Source: ClinicalTrials.gov · NCT03975231 · last updated 2026-04-08