# A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Source: https://onco.cc/trials/nct05144854/  
OnCo record `nct05144854` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Ipilimumab, Oxaliplatin and Capecitabine in gastric & gastro-oesophageal junction cancer, run by Ono Pharmaceutical Co., Ltd., active and no longer recruiting.

## Summary

A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer) is a phase 3 interventional study registered as NCT05144854 by Ono Pharmaceutical Co., Ltd., with 626 participants enrolled, started 2021-11-05 and due to reach its primary completion in 2025-10-20. Interventions recorded: ONO-4538, Ipilimumab, Oxaliplatin, Capecitabine and S-1.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05144854
- Phase: 3
- Setting: A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus 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: 626

## Sources

- ClinicalTrials.gov NCT05144854: https://clinicaltrials.gov/study/NCT05144854

## Connected records

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

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