drugset / Trial / NCT06001658
Perioperative Gemcitabine, Cisplatin, and Pembrolizumab in Potentially Resectable Biliary Tract Cancers
Phase 2
Recruiting
27 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Merck Sharp & Dohme LLC · collab
NaSingle-groupOpen-labelTreatment
Summary
The purpose of this study is to determine the safety of peri-operative gemcitabine, cisplatin, and pembrolizumab in patients with BTC, as well as whether the combination of gemcitabine, cisplatin, and pembrolizumab (gem/cis/pembro) is feasible and lead to pathologic responses.
Timeline
- Start
- 2024-07-08
- Primary completion
- 2028-06
- Completion
- 2028-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cisplatin | Other / unclassified | 25 mg/m2 | Intravenous |
| Subject | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |