ONO-4538 Phase II Study A Multicenter, Open-label, Uncontrolled Study in Biliary Tract Cancer(ONO-4538-91)

ONO PHARMACEUTICAL CO., LTD.0 个研究点目标入组 80 人开始时间: 2020年1月7日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•1. Sex: Both men and women
•2. Age (at the time of informed consent): at least 20 years old
•3. Patients with histologically or cytologically confirmed biliary tract cancer (including intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, and duodenal papilla cancer) which has been confirmed to be adenocarcinoma
•4. Patients with unresectable or recurrent biliary tract cancer refractory or intolerant to gemcitabine-based and S-1-based regimens
•5. Centrally-assessed CPS of >=1

•1. Patients with known high microsatellite instability (MSI-H) or deficient mismatch repair (dMMR)
•2. Patients with current or previous severe hypersensitivity reactions to other antibody products
•3. Have previously received ONO-4538 (MDX-1106 or BMS-936558), anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody, anti-CD137 antibody, anti-CTLA-4 antibody, or any other therapeutic antibodies or pharmacotherapies, including cancer vaccines, for regulation of T cells

发起方

ONO PHARMACEUTICAL CO., LTD.