# ROAR (Rare Oncology Agnostic Research) basket: BRAF V600E biliary tract cancer cohort

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

## TL;DR

In the ROAR basket trial, the BRAF-blocking pair dabrafenib and trametinib shrank tumours in about half of 43 people with bile duct or gallbladder cancer carrying the BRAF V600E mutation, which is found in roughly 5 percent of biliary cancers. The pair is approved for any solid tumour with this mutation in the United States and is listed by guidelines for biliary cancer.

## Summary

ROAR (NCT02034110) was a phase 2, open-label, single-arm, multicentre basket trial of dabrafenib plus trametinib in BRAF V600E-mutated rare cancers across nine cohorts (anaplastic thyroid, biliary tract, gastrointestinal stromal tumour, small-bowel adenocarcinoma, low- and high-grade glioma, hairy cell leukaemia, multiple myeloma and adenocarcinoma of unknown primary). The biliary tract cohort enrolled 43 previously treated patients between 2014 and 2018; investigator-assessed overall response, the primary endpoint, was achieved by 22 of 43 (51 percent, 95 percent confidence interval 36 to 67) and independent-review response by 20 of 43 (47 percent), at a median follow-up of 10 months. The most common grade 3 or worse adverse event was raised gamma-glutamyltransferase (12 percent); 40 percent had serious adverse events, 21 percent treatment-related, most often pyrexia. BRAF V600E is found in about 5 percent of biliary tract tumours and is less common in gallbladder cancer than in intrahepatic cholangiocarcinoma. The FDA approved dabrafenib with trametinib for BRAF V600E solid tumours on a tumour-agnostic basis in June 2022 with ROAR among the supporting trials; NCCN lists the pair for biliary cancer, and in the UK the combination is not appraised by NICE for biliary cancer.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-24
- Also known as: ROAR
- Registry id: NCT02034110
- Phase: 2
- Setting: BRAF V600E-mutated rare cancers in nine histology cohorts, including previously treated unresectable, metastatic or recurrent biliary tract cancer (n=43): dabrafenib 150 mg twice daily plus trametinib 2 mg daily, single arm
- Sponsor: Novartis Pharmaceuticals
- Enrolled: 206
- Result: Biliary cohort ORR 51% (22/43, investigator) and 47% (independent review); grade 3 or worse GGT rise 12%.
- Outcomes: Overall response rate, biliary tract cancer cohort (investigator-assessed): Dabrafenib + trametinib 51%; Overall response rate, biliary tract cancer cohort (independent review): Dabrafenib + trametinib 47%

## Sources

- ClinicalTrials.gov NCT02034110: https://clinicaltrials.gov/study/NCT02034110
- Subbiah et al., Lancet Oncology 2020: dabrafenib plus trametinib in BRAF V600E biliary tract cancer (ROAR): https://doi.org/10.1016/S1470-2045(20)30321-1

## Connected records

- cancers: [Biliary tract cancer (all types)](https://onco.cc/cancers/biliary-tract-cancer/), [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Gallbladder cancer](https://onco.cc/cancers/gallbladder/)
- terms: [Basket, umbrella, and platform trials](https://onco.cc/terms/basket-umbrella-platform/), [Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)](https://onco.cc/terms/gallbladder-cancer-in-biliary-trials/), [Rare cancers](https://onco.cc/terms/rare-cancers/), [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [BRAF](https://onco.cc/targets/braf/)
- drugs: [Dabrafenib](https://onco.cc/drugs/dabrafenib/), [Dabrafenib + trametinib](https://onco.cc/drugs/dabrafenib-trametinib/), [Trametinib](https://onco.cc/drugs/trametinib/)
- companies: [Novartis](https://onco.cc/companies/novartis/)
- key papers: [Dabrafenib plus trametinib in patients with BRAF V600E -mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial](https://onco.cc/key-papers/paper-roar-lancet-oncol-2020/), [Dabrafenib plus trametinib in patients with BRAF V600E-mutant anaplastic thyroid cancer: updated analysis from the phase II ROAR basket study](https://onco.cc/key-papers/paper-roar-ann-oncol-2022-update/)

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