drugset / Trial / NCT06256328
A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Timeline
- Start
- 2024-01-10
- Primary completion
- 2025-10-09
- Completion
- 2027-07-31
Outcome
Met primary endpoint
release “met the primary endpoint in the Phase 2 clinical trial ( ONO-4578-08 study ) in patients with previously untreated, HER2-negative” ono-pharma.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BMS-986310 | Small molecule | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | S-1 | Small molecule | — | — |