drugset / Trial / NCT07369791
Nivolumab Plus Relatlimab and Gemcitabine/Cisplatin as First-Line Treatment in Advanced Biliary Tract Cancer.
RandomizedParallel-groupOpen-labelTreatment
Summary
A Randomized Phase II Study. To assess the difference in objective response rate (ORR) between adult patients with advanced biliary tract cancer assigned to nivolumab plus relatlimab 360 mg/360 mg in combination with GC or nivolumab plus GC as first-line treatment.
Timeline
- Start
- 2026-12
- Primary completion
- 2035-12
- Completion
- 2040-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Nivolumab | Monoclonal antibody | 360 mg | — |
| Subject | Relatlimab | Monoclonal antibody | 360 mg | — |
| Background | Cisplatin | Other / unclassified | 25 mg/m2 | — |
| Background | Gemcitabine | Small molecule | 1000 mg/m2 | — |