drugset / Trial / NCT03260712
Pembrolizumab in Biliary Tract Cancer
NaSingle-groupOpen-labelTreatment
Summary
This is a single-arm, multi-centre, phase II study in biliary tract cancer (BTC) patients. The main objective is to detect an increase in progression-free survival rate at 6 months (according to RECIST version 1.1) from 60% in patients with BTC treated with standard chemotherapy (CT) approach to 75% when treated with CT combined with pembrolizumab.
Timeline
- Start
- 2020-01-07
- Primary completion
- 2023-04-27
- Completion
- 2023-08-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | — |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | — |