# 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)

Source: https://onco.cc/trials/nct06256328/  
OnCo record `nct06256328` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of Oxaliplatin, Capecitabine and Nivolumab in gastric & gastro-oesophageal junction cancer, run by Ono Pharmaceutical Co., Ltd., active and no longer recruiting.

## Summary

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) is a phase 2 interventional study registered as NCT06256328 by Ono Pharmaceutical Co., Ltd., with 226 participants enrolled, started 2024-01-10 and due to reach its primary completion in 2025-10-09. Interventions recorded: ONO-4578, Oxaliplatin, Capecitabine, S-1, Nivolumab and Placebo.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06256328
- Phase: 2
- Setting: A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
- Sponsor: Ono Pharmaceutical Co., Ltd.
- Enrolled: 226

## Sources

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

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [Nivolumab](https://onco.cc/drugs/nivolumab/), [Oxaliplatin](https://onco.cc/drugs/oxaliplatin/)
- companies: [Deciphera Pharmaceuticals (Ono)](https://onco.cc/companies/deciphera/)

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