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)

Brief summary (registry, in English)

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).

What you commit to

• Study type: Interventional · Phase 2
• Participants enrolled: 226
• From 10 Jan 2024 to the primary completion date, 9 Oct 2025
• 63 sites in 3 countries
• Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (63)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Related publications

• EP4 Antagonist ONO-4578 Plus Nivolumab and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer.J Clin Oncol · 2026 · PMID 42223130