# 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)

> **NCT06256328** · PHASE2 · ACTIVE_NOT_RECRUITING · sponsor: **Ono Pharmaceutical Co., Ltd.** · enrollment: 226 (actual)

## Conditions studied

- Gastric Cancer

## Interventions

- **DRUG:** ONO-4578
- **DRUG:** Oxaliplatin
- **DRUG:** Capecitabine
- **DRUG:** S-1
- **DRUG:** Nivolumab
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT06256328
- **Lead sponsor:** Ono Pharmaceutical Co., Ltd.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2024-01-10
- **Primary completion:** 2025-10-09
- **Final completion:** 2027-07-31
- **Target enrollment:** 226 (ACTUAL)
- **Last updated:** 2026-03-13


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06256328

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration 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)". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT06256328. Licensed CC0.

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