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A planned American cooperative-group trial will test whether the PD-1 and VEGF bispecific antibody ivonescimab beats the current immunotherapies when added to first-line chemotherapy for bile duct and gallbladder cancer, with survival as the endpoint.
This ECOG-ACRIN randomised phase 2/3 (NCT07765433) compares ivonescimab with gemcitabine and cisplatin against standard-of-care chemo-immunotherapy (gemcitabine and cisplatin with durvalumab or pembrolizumab) in patients with histologically or cytologically confirmed adenocarcinoma of the biliary tract, including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder carcinoma, that is locally advanced or metastatic. The primary endpoint is overall survival; 336 patients are planned, with a start date of January 2027 and primary completion in December 2028. It is the first-line counterpart of the European SEVILLA trial and the first phase 3-scale test of a bispecific checkpoint antibody in biliary cancer against the TOPAZ-1 and KEYNOTE-966 standards.
Shares Ivonescimab, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, VEGF / VEGFR.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Durvalumab.
Shares Gemcitabine + cisplatin, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), PD-1.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types), Durvalumab.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (all types).