Patients with unresectable or recurrent biliary tract cancer (including intrahepatic bile duct cancer, extrahepatic bile duct cancer, gallbladder cancer, and duodenal papilla cancer) that is refractory or intolerant to gemcitabine-based and S-1-based regimens with CPS >=1.
Conditions
Interventions
investigational material(s)
Generic name etc : Nivolumab (ONO-4538/BMS-936558)
INN of investigational material : Nivolumab
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administrat
Sponsors
ONO PHARMACEUTICAL CO., LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy safety Objective response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy safety Overall survival (OS) | — |
Countries
Japan
Outcome results
None listed