NCT04940052Active, 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
A Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the 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 (DTC)
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 153 (actual)
- First submitted
- 22 Jun 2021
- Start date
- 15 Nov 2021
- Primary completion date
- 22 Jan 2025
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Thyroid cancer
- NCT number
- NCT04940052
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 153
- From 15 Nov 2021 to the primary completion date, 22 Jan 2025
- 34 sites in 11 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Anaplastic or medullary carcinoma of the thyroid
- A history or current evidence/risk of retinal vein occlusion (RVO) or central serous retinopathy
- Other inclusion/exclusion criteria may apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (34)
Sites in registry order. Pick your city on the disease page to sort them by distance.
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.