drugset / Trial / NCT05239169
Immunotherapy With Durva and Treme With or Without Capecitabine in Adjuvant Treatment for Biliary Tract Cancer
Phase 2
Completed
40 enrolled
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an interventional, prospective multicenter, open-label, phase II study in patients after curative surgery for BTC in a classic adjuvant situation, consisting of a two arm feasibility pilot part with a randomized pick-the-winner design and an option to proceed into a randomized phase 2/3 trial in order to compare the winner with the current SOC (capecitabine).
Timeline
- Start
- 2022-05-23
- Primary completion
- 2025-02-20
- Completion
- 2025-02-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 1250 mg/m2 | Oral |
| Subject | Durvalumab | Monoclonal antibody | 1500 mg | Intravenous |
| Subject | Tremelimumab | Monoclonal antibody | 300 mg | Intravenous |