LAUSR

TPS509Background: Angiogenesis and aberrant MET signaling are implicated in the pathogenesis and progression of invasive biliary tract cancers (BTC), including adenocarcinomas of the gallbladder, intra- and extra-hepatic bile ducts, and ampulla of Vater. JSBF (NCT02711553) is a phase II, multicenter, randomized, and double-blinded study, designed to evaluate the efficacy and safety of standard of care (SOC) gemcitabine and cisplatin in combination with either ramucirumab (human IgG1 VEGFR2 monoclonal antibody) or merestinib (oral type II MET kinase inhibitor) or respective placebo for the first-line treatment of advanced or metastatic BTC. Methods: Eligible patients with advanced or metastatic BTC will be randomized to oral merestinib 80 mg, oral placebo, intravenous (IV) ramucirumab 8mg/kg, or IV placebo, in a 2:1:2:1 fashion. Randomization will be stratified by primary tumor site, presence of metastases, and geographic region. In addition to the randomly assigned treatment, all patients will receive SOC...