Clinical trial · Interventional
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)
NCT04940052CI-TRIAL-00115988active not recruitingPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Differentiated Thyroid Cancer (DTC) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dabrafenib | Drug | Dabrafenib | ALIAS |
| Dabrafenib placebo | Drug | — | UNRESOLVED |
| Trametinib | Drug | Trametinib | ALIAS |
| Trametinib Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dabrafenib plus Trametinib
- description
- Eligible participants will receive Dabrafenib 150 mg twice a day (BID) and Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.
- interventionNames
- Drug: Dabrafenib
- Drug: Trametinib
- type
- PLACEBO_COMPARATOR
- label
- Dabrafenib Placebo plus Trametinib Placebo
- description
- Eligible participants will receive matching placebo for Dabrafenib 150 mg twice a day (BID) and matching placebo for Trametinib 2 mg once a day (QD) until disease progression as per RECIST 1.1 as confirmed by blinded independent review committee (BIRC), unacceptable toxicity, pregnancy, loss of clinical benefit as determined by the investigator, withdrawal of consent, lost to follow-up, death, or study termination by the sponsor.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDGao M, Park YJ, Lin CC, Krzyzanowska MK, Li Z, Tsai HJ, Shi F, Qin J, Choong SH, Lin Y, Zhang Y, Kang JH, Hoff AO, Tan M, Roughton M, Paul M, Wirth LJ. Efficacy and safety of dabrafenib plus trametinib in adults with differentiated thyroid cancer: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2026 Aug;27(8):994-1003. doi: 10.1016/S1470-2045(26)00133-6. Epub 2026 Jul 13. PMID 42442381