Clinical trial · Interventional
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)
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
| ONO-4578 | Drug | — | UNRESOLVED |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Placebo | Drug | — | UNRESOLVED |
| S-1 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- ONO-4578+Nivolumab+chemotherapy
- interventionNames
- Drug: ONO-4578
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: S-1
- Drug: Nivolumab
- type
- PLACEBO_COMPARATOR
- label
- placebo+Nivolumab+chemotherapy
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Drug: S-1
- Drug: Nivolumab
- Drug: Placebo
Primary outcomes (1)
- measure
- Progression-free survival (PFS) (site investigator assessment)
- timeFrame
- up to 2years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma * Patients have not been treated with systemic chemotherapy as first-line therapy * Patients who can provide tumor tissue samples Exclusion Criteria: * Patients unable to take oral medicines * Patients with HER2-positive * Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine * Patients who have a history of severe drug-related adverse reactions caused by non- steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused by NSAIDs requiring treatment * Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis * Patients with headache and/or nausea associated with brain metastasis
References
Publications (1)
- DERIVEDNakayama I, Ryu MH, Lim SH, Kim JG, Omori T, Oh SC, Kim JY, Rha SY, Lee KW, Machida N, Sym SJ, Narita Y, Park YI, Hara H, Hosaka H, Kang B, Kim IH, Bai LY, Hirashima Y, Hagihara S, Yamamoto T, Shitara K. 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 Aug 10;44(23):2198-2210. doi: 10.1200/JCO-26-01072. Epub 2026 Jun 1. PMID 42223130