A second immunotherapy trial confirmed the modest survival benefit of adding PD-1 blockade to chemotherapy in bile duct cancer.
KEYNOTE-966, trial NCT04003636 sponsored by Merck and reported in 2023, was the second immunotherapy trial to confirm a modest survival benefit from adding PD-1 blockade to chemotherapy in first-line advanced biliary tract cancer. It randomised 1,069 patients to pembrolizumab or placebo with gemcitabine and cisplatin, with gemcitabine continued beyond eight cycles in both arms, met its primary overall survival endpoint and led to approval in October 2023. OnCo links it to biliary tract and gallbladder cancer, pembrolizumab, gemcitabine plus cisplatin and the pairing of chemotherapy with PD-1 or PD-L1 blockade, and it replicates TOPAZ-1. Whether the modest median gain justifies routine use for every patient, given the cost, is the open question.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Shares A clinical trial or standard treatment for gallbladder cancer, Gemcitabine-cisplatin + PD-(L)1 blockade in biliary cancer, Report gallbladder cancer as its own population in every biliary trial, Gallbladder adenocarcinoma.
Shares Report gallbladder cancer as its own population in every biliary trial, Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma.
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma).
Shares Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma).
Shares Extrahepatic cholangiocarcinoma (perihilar and distal), Intrahepatic cholangiocarcinoma, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups), Biliary tract cancer (cholangiocarcinoma).
Shares A clinical trial or standard treatment for gallbladder cancer, Gemcitabine + cisplatin, Extrahepatic cholangiocarcinoma (perihilar and distal), Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials.