# Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refracto

Source: https://onco.cc/trials/nct04940052/  
OnCo record `nct04940052` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Dabrafenib, Trametinib in thyroid cancer, run by Novartis Pharmaceuticals, active and no longer recruiting.

## Summary

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 is a phase 3 interventional study registered as NCT04940052 by Novartis Pharmaceuticals, with 153 participants enrolled, started 2021-11-15 and due to reach its primary completion in 2025-01-22. Interventions recorded: Dabrafenib, Trametinib, Trametinib Placebo, Dabrafenib placebo. Conditions listed: Differentiated Thyroid Cancer (DTC). Results were posted on ClinicalTrials.gov in 2026; the figures recorded here are the registry's, not a publication's.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-22
- Tags: ctgov-ingest
- Registry id: NCT04940052
- Phase: 3
- Setting: 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)
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 153
- Outcomes: Progression Free Survival (PFS): Dabrafenib Plus Trametinib 12.8 months vs Dabrafenib Placebo Plus Trametinib Placebo 3.7 months, HR 0.38; Overall Response Rate (ORR): Dabrafenib Plus Trametinib 57.4% vs Dabrafenib Placebo Plus Trametinib Placebo 3.8%

## Sources

- ClinicalTrials.gov NCT04940052: https://clinicaltrials.gov/study/NCT04940052

## Connected records

- cancers: [Thyroid cancer](https://onco.cc/cancers/thyroid/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- drugs: [Dabrafenib](https://onco.cc/drugs/dabrafenib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- companies: [Novartis](https://onco.cc/companies/novartis/)

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