For Healthcare Professionals

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

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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)
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:

  1. Signed informed consent must be obtained prior to performing any specific pre-screening and screening procedure
  2. Male or female >= 18 years of age at the time of informed consent
  3. Histologically or cytologically confirmed diagnosis of advanced/metastatic differentiated thyroid cancer
  4. Radio active iodine refractory disease
  5. BRAFV600E mutation positive tumor sample as per Novartis designated central laboratory result
  6. Has progressed on at least 1 but not more than 2 prior VEGFR targeted therapy
  7. Eastern Cooperative Oncology Group performance status >= 2
  8. At least one measurable lesion as defined by RECIST 1.1

EXCLUSION CRITERIA

Exclusion Criteria:

  1. Anaplastic or medullary carcinoma of the Tyroid
  2. Previous treatment with BRAF inhibitor and/or MEK inhibitor
  3. Concomitant RET Fusion Positive Thyroid cancer
  4. Receipt of any type of small molecule kinase inhibitor within 2 weeks before randomization
  5. Receipt of any type of cancer antibody or systemic chemotherapy within 4 weeks before randomization
  6. Receipt of radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before randomization
  7. A history or current evidence/risk of retinal vein occlusion or central serous retinopathy
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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.
Phone iconCall 1-888-669-6682Email iconEmail Study Center

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

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