Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated P… (NCT04940052) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refractory BRAF V600E Mutation Positive Differentiated Thyroid Cancer
United States, Argentina, Brazil153 participantsStarted 2021-11-15
Plain-language summary
The purpose of this study is to assess the efficacy and safety of dabrafenib in combination with trametinib for treating adult patients with locally advanced or metastatic Differentiated Thyroid Cancer (DTC) harboring the BRAFV600E mutation, who are refractory to radioactive iodine (RAI) therapy and have experienced disease progression following one or two prior VEGFR-targeted treatments.
Who can participate
Age range
18 Years – 99 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.
Key Inclusion Criteria:
* Signed informed consent
* Male or female ≥ 18 years of age at time of informed consent
* Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid carcinoma
* Radioactive-iodine refractory disease
* BRAF V600E mutation-positive tumor sample as per central laboratory result
* Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapies
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* At least one measurable lesion as defined by RECIST v1.1.
Key Exclusion Criteria:
* Anaplastic or medullary carcinoma of the thyroid
* Previous treatment with a BRAF inhibitor and/or a MEK inhibitor
* Concomitant RET Fusion-Positive Thyroid Cancer
* Treatment with any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 2 weeks before randomization
* Treatment with any type of anticancer antibody (including investigational antibody) or systemic chemotherapy within 4 weeks before randomization
* Treatment with radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization
* A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
Other inclusion/exclusion criteria may apply.
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
1
Progression Free Survival (PFS)
Timeframe: From randomization to first documented progression or deaths, whichever comes first, assessed up to approximately 3 years