{"entity":{"id":"roar-atc","kind":"trial","name":"ROAR (anaplastic thyroid cancer cohort)","aka":[],"tldr":"Turned the thyroid cancer with the shortest survival, once measured in months, into a treatable disease for the third of patients whose tumours carry a BRAF mutation.","summary":"ROAR, trial NCT02034110 sponsored by Novartis, is the phase 2 basket study whose anaplastic thyroid cancer cohort turned the thyroid cancer with the shortest survival, once measured in months, into a treatable disease for the roughly third of patients whose tumours carry a BRAF V600E mutation. In 36 patients treated with dabrafenib plus trametinib the objective response rate was 56 percent, with survival far beyond historical expectations in the 2022 update in Annals of Oncology, leading to FDA approval in May 2018 as the first targeted therapy for the disease; neoadjuvant use now enables surgery in previously unresectable tumours. OnCo links it to thyroid cancer, BRAF as a target, the dabrafenib plus trametinib record, MD Anderson, Maria E. Cabanillas and the pairing of BRAF and MEK inhibition before surgery. Whether adding PD-1 blockade should become standard is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT02034110","url":"https://clinicaltrials.gov/study/NCT02034110"},{"label":"Updated analysis, Annals of Oncology 2022","url":"https://www.sciencedirect.com/science/article/pii/S0923753422000059"}],"tags":[],"related":[],"cancers":["thyroid"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["braf"],"drugs":["dabrafenib-trametinib"],"companies":["novartis"],"institutions":["md-anderson"],"pathways":[],"terms":[],"trials":[],"people":["maria-cabanillas"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02034110","phase":"2","setting":"BRAF V600E-mutant anaplastic thyroid cancer: dabrafenib + trametinib","sponsor":"Novartis","result":"ORR 56%; median OS 15 months.","started":"2014-03-12","startedType":"actual","yearReported":2018,"enrolled":36,"enrolledBasis":"registry","outcomes":[{"endpoint":"Objective response rate","primary":true,"unit":"%","arms":[{"name":"Dabrafenib + trametinib","n":36,"value":56}],"source":"https://www.sciencedirect.com/science/article/pii/S0923753422000059"}],"replication":"Consistent with MD Anderson real-world series of neoadjuvant BRAF/MEK in ATC."},"route":"/trials/roar-atc/","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/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"}],"drug":[{"id":"dabrafenib-trametinib","kind":"drug","name":"Dabrafenib + trametinib","route":"/drugs/dabrafenib-trametinib/"}],"company":[{"id":"novartis","kind":"company","name":"Novartis","route":"/companies/novartis/"}],"institution":[{"id":"md-anderson","kind":"institution","name":"MD Anderson Cancer Center","route":"/institutions/md-anderson/"}],"person":[{"id":"maria-cabanillas","kind":"person","name":"Maria E. Cabanillas","route":"/people/maria-cabanillas/"}],"pairing":[{"id":"braf-mek-neoadjuvant-atc","kind":"pairing","name":"BRAF/MEK inhibition → surgery in anaplastic thyroid cancer","route":"/pairings/braf-mek-neoadjuvant-atc/"}],"idea":[{"id":"idea-atc-triplet-io","kind":"idea","name":"BRAF/MEK plus PD-1 blockade as standard for BRAF-mutant anaplastic thyroid cancer","route":"/ideas/idea-atc-triplet-io/"}],"term":[{"id":"basket-trial","kind":"term","name":"Basket trial","route":"/terms/basket-trial/"},{"id":"basket-umbrella-platform","kind":"term","name":"Basket, umbrella, and platform trials","route":"/terms/basket-umbrella-platform/"},{"id":"orr","kind":"term","name":"Objective response rate (ORR)","route":"/terms/orr/"},{"id":"single-arm","kind":"term","name":"Single-arm trial","route":"/terms/single-arm/"}]}}