ONO-4578-08:A study to investigate the efficacy and safety of ONO-4578 in combination with nivolumab and chemotherapy compared with those of placebo in combination with nivolumab and chemotherapy in chemotherapy-naive participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

ONO-4578-08:A randomized, multicenter, double-blind, phase 2 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-naive participants with human epidermal growth factor receptor 2 (HER2)-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031230389

Enrollment

210

Registered

2023-10-12

Start date

2024-01-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unresectable Advanced or Recurrent Gastric Cancer

Interventions

ONO-4578 or placebo will be used in combination with nivolumab and chemotherapy (S-1 plus oxaliplatin combination therapy [SOX therapy] or capecitabine plus oxaliplatin combination therapy [CapeOX the

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma 2. Patients have not been treated with systemic chemotherapy as first-line therapy 3. Patients who can provide tumor tissue samples

Exclusion criteria

Exclusion criteria: 1. Patients unable to take oral medicines 2. Patients with HER2-positive 3. Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine 4. 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 5. Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis 6. Patients with headache and/or nausea associated with brain metastasis

Design outcomes

Primary

Measure	Time frame
Efficacy (PFS)	—

Secondary

Measure	Time frame
Efficacy(OS and others) and Safety	—

Countries

Japan, Korea, Taiwan

Contacts

Public ContactCenter Medical

Ono Pharmaceutical Co.,LTD

clinical_trial@ono-pharma.com+81-120626190

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026