A phase III study of ONO-4538 (ONO-4538-38/BMS CA209844)

A multicenter, double-blind, randomized study in patients with gastric cancer undergoing postoperative adjuvant chemotherapy (ONO-4538-38/BMS CA209844)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223213

Enrollment

700

Registered

2016-05-23

Start date

2017-01-31

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. With histologically confirmed adenocarcinoma of the stomach 2. Without remnant cancer who have undergone gastrectomy by laparotomy

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
efficacy relapse-free survival (RFS)	—

Secondary

Measure	Time frame
safety efficacy Overall survival (OS), 3- and 5-year OS rate, 3- and 5-year RFS rate	—

Countries

Asia

Outcome results

None listed

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