drugset / Trial / NCT07818070
A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
Phase 3
Not yet recruiting
600 enrolled
Ono Pharmaceutical Co., Ltd.
Deciphera Pharmaceuticals, LLC · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. Participants will: * Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy. * Make visits to the clinic for checkups and tests. * Answer questions about their health throughout the trial.
Timeline
- Start
- 2027-02
- Primary completion
- 2031-01
- Completion
- 2031-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BMS-986310 | Small molecule | — | — |
| Background | Capecitabine | Small molecule | — | — |
| Background | Leucovorin | Small molecule | — | — |
| Background | Levoleucovorin | Unknown | — | — |
| Background | Nivolumab | Monoclonal antibody | — | — |
| Background | Oxaliplatin | Small molecule | — | — |
| Background | fluorouracil | Small molecule | — | — |
| Background | tegafur-gimeracil-oteracil potassium | Small molecule | — | — |