A phase II/III study of ONO-4538 (ONO-4538-37)

A multicenter, randomized phase II/III study in gastric cancer patients (ONO-4538-37)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223111

Enrollment

680

Registered

2016-02-24

Start date

2016-04-22

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

Gastric cancer

Interventions

investigational material(s) Generic name etc : ONO-4538 INN of investigational material : nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. ECOG Performance Status score 0 or 1 2. Life expectancy of at least 3 months 3. Have measurable lesions as defined in RECIST ver. 1.1

Exclusion criteria

Exclusion criteria: 1. Have multiple cancers 2. Have a current or past history of severe hypersensitivity to any other antibody products

Design outcomes

Primary

Measure	Time frame
safety efficacy Progression free survival, Overall survival	—

Secondary

Measure	Time frame
safety efficacy Objective response rate, safety, etc.	—

Countries

Asia except Japan, Japan

Outcome results

None listed

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