{"entity":{"id":"nct04940052","kind":"trial","name":"Study of Efficacy and Safety of Dabrafenib in Combination With Trametinib in Previously Treated Patients With Metastatic, Radio-active Iodine Refracto","aka":[],"tldr":"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.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04940052","url":"https://clinicaltrials.gov/study/NCT04940052"}],"tags":["ctgov-ingest"],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":[],"drugs":["dabrafenib","trametinib"],"companies":["novartis"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"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","started":"2021-11-15","startedType":"actual","yearReported":2026,"enrolled":153,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression Free Survival (PFS)","primary":true,"unit":"months","arms":[{"name":"Dabrafenib Plus Trametinib","n":101,"value":12.8,"note":"95% CI 10.2 to 21.2; Figures from the ClinicalTrials.gov results section (first posted 2026-05-22), not from a publication"},{"name":"Dabrafenib Placebo Plus Trametinib Placebo","n":52,"value":3.7,"note":"95% CI 2.3 to 7.5"}],"hr":0.38,"ci":[0.25,0.57],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04940052?tab=results"},{"endpoint":"Overall Response Rate (ORR)","unit":"%","arms":[{"name":"Dabrafenib Plus Trametinib","n":101,"value":57.4,"note":"95% CI 47.2 to 67.2; Figures from the ClinicalTrials.gov results section (first posted 2026-05-22), not from a publication"},{"name":"Dabrafenib Placebo Plus Trametinib Placebo","n":52,"value":3.8,"note":"95% CI 0.5 to 13.2"}],"p":"<0.001","source":"https://clinicaltrials.gov/study/NCT04940052?tab=results"}]},"route":"/trials/nct04940052/","neighbours":{"cancer":[{"id":"thyroid","kind":"cancer","name":"Thyroid cancer","route":"/cancers/thyroid/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"dabrafenib","kind":"drug","name":"Dabrafenib","route":"/drugs/dabrafenib/"},{"id":"trametinib","kind":"drug","name":"Trametinib","route":"/drugs/trametinib/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}]}}