ONO-4538 Phase II Study (ONO-4538-91/TASUKI-91)
- Conditions
- 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.
- Registration Number
- JPRN-jRCT2080225006
- Lead Sponsor
- ONO PHARMACEUTICAL CO., LTD.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>safety<br>Objective response rate (ORR)
- Secondary Outcome Measures
Name Time Method efficacy<br>safety<br>Overall survival (OS)