drugset / Trial / NCT06467357
Phase 3 Study of T-DXd and Rilvegostomig Versus SoC in Advanced HER2-expressing Biliary Tract Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to measure the efficacy and safety of T-DXd with rilvegostomig or T-DXd monotherapy compared with gemcitabine plus cisplatin and durvalumab in patients with advanced treatment naïve HER2-expressing BTC.
Timeline
- Start
- 2024-08-12
- Primary completion
- 2028-06-12
- Completion
- 2029-05-16
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | — | Intravenous |
| Comparator | Durvalumab | Monoclonal antibody | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Subject | Rilvegostomig | Other / unclassified | — | Intravenous |
| Subject | Trastuzumab deruxtecan | Monoclonal antibody | — | Intravenous |