Skip to content
Bending the Curve Trial by Trial
?

ROAR

A Phase II, Open-label, Study in Subjects With BRAF V600E-Mutated Rare Cancers With Several Histologies to Investigate the Clinical Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib: biliary tract cancer cohort

Phase 2N = 43NCT02034110

Population
Adults with BRAF V600E-mutated unresectable, metastatic, locally advanced or recurrent biliary tract cancer, ECOG performance status 0-2, who had received previous systemic treatment; 43 evaluable patients.
Design
Part of an ongoing phase 2, open-label, single-arm, multicentre basket trial (Rare Oncology Agnostic Research, ROAR); this record covers the biliary tract cancer cohort given dabrafenib 150 mg twice daily plus trametinib 2 mg once daily until progression or intolerance. Primary endpoint: overall response rate by RECIST 1.1 in the intention-to-treat evaluable population. Results are from an interim analysis; median follow-up 10 months (IQR 6-15). The registry record covers all ROAR cohorts (206 patients). Single-arm; no comparison group.
Primary endpoint
ORR
Arms
  • Dabrafenib plus trametinib (experimental, n = 43): Dabrafenib 150 mg orally twice daily plus trametinib 2 mg orally once daily
People
Subbiah V
Show the numbers
Results reported for ROAR
EndpointAnalysisDabrafenib plus trametinibControlEffect
ORREvaluable BRAF V600E-mutated biliary tract cancer patients (43)Overall response by investigator assessment (RECIST 1.1)interimmedian follow-up 10 monthsSubbiah 202051% (36–67%)—22 of 43 patients responded.
ORREvaluable BRAF V600E-mutated biliary tract cancer patients (43)Overall response by independent reviewer assessmentinterimmedian follow-up 10 monthsSubbiah 202047% (31–62%)—20 of 43 patients responded.
Results reported for ROAR
EndpointAnalysisDabrafenib plus trametinibControlEffect
ORREvaluable BRAF V600E-mutated biliary tract cancer patients (43)Overall response by investigator assessment (RECIST 1.1)interimmedian follow-up 10 monthsSubbiah 202051% (36–67%)—22 of 43 patients responded.
ORREvaluable BRAF V600E-mutated biliary tract cancer patients (43)Overall response by independent reviewer assessmentinterimmedian follow-up 10 monthsSubbiah 202047% (31–62%)—20 of 43 patients responded.
Primary publication: Subbiah V, Lassen U, Élez E, Italiano A, Curigliano G, Javle M, et al. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020;21(9):1234-1243. PubMedDOI

Appears in

Sources

  1. Subbiah V, Lassen U, Élez E, Italiano A, Curigliano G, Javle M, et al. Dabrafenib plus trametinib in patients with BRAF(V600E)-mutated biliary tract cancer (ROAR): a phase 2, open-label, single-arm, multicentre basket trial. Lancet Oncol. 2020;21(9):1234-1243.

    PubMedDOI