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Part of the American ComboMATCH precision-medicine programme, this trial adds the MEK inhibitor binimetinib to FOLFOX for people whose bile duct or gallbladder cancer carries a KRAS or related pathway mutation, the most common gallbladder cancer drivers.
This ComboMATCH treatment trial (NCT05564403) randomises patients with histologically confirmed unresectable or recurrent biliary tract cancer (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or gallbladder cancer) and a confirmed RAS/RAF/MEK/ERK pathway mutation by any CLIA-certified method, excluding BRAF V600E, to second-line FOLFOX with or without binimetinib. The primary endpoint is overall survival; 66 patients are planned at 207 US sites, the trial opened in February 2024, is active but no longer recruiting, and lists primary completion in October 2026. KRAS mutations are among the most frequent alterations in gallbladder cancer, and this is one of the few trials that selects biliary patients on MAPK pathway status rather than treating them as one group.
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares Leucovorin (folinic acid), Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin.
Shares Leucovorin (folinic acid), Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin.
Shares Leucovorin (folinic acid), Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Leucovorin (folinic acid), Oxaliplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), FOLFOX (5-FU, leucovorin, oxaliplatin).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Oxaliplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Intrahepatic cholangiocarcinoma, Oxaliplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma).
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