Study of Efficacy and Safety of Dabrafenib Plus Trametinib in Previously Treated Patients With Locally Advanced or Metastatic, Radio-active Iodine Refractory BRAFV600E Mutation-positive Differentiated Thyroid Cancer
About the study
150 adults patients with locally advanced or metastatic BRAFV600E mutation-positive, differentiated thyroid carcinoma who are refractory to radioactive iodine and have progressed following prior VEGFR targeted therapy will enter in the trial. Patients will be randomized in a 2:1 ratio to either dabrafenib plus trametinib or placebo. Patients will be stratified by number of prior VEGFR targeted therapy (1versus2) and prior lenvatinib treatment (yes versus no)
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure
- Male or female >= 18 years of age at the time of informed consent
- Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid cancer
- Radio active iodine refractory disease
- BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result
- Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy
- Eastern Cooperative Oncology Group performance status >= 2
- At least one measurable lesion as defined by RECIST 1.1
EXCLUSION CRITERIA
Exclusion Criteria:
- Anaplastic or medullary carcinoma of the Tyroid
- Previous treatment with BRAF inhibitor and/or MEK inhibitor
- Concomitant RET Fusion Positive Thyroid cancer
- Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization
- Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeks before randomization
- Receipt of 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 or central serous retinopathy
Study Locations
Enter your ZIP code/Postal code/PIN code to locate study sites near you:
How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Differentiated Thyroid Cancer
Age (in years)
18+
Phase
Phase 3
Participants needed
150
Est. Completion Date
Oct 30, 2026
Treatment type
Interventional
Sponsor
Novartis
ClinicalTrials.gov identifier
NCT04940052
Study number
CDRB436J12301
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?