Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal or Gastroesophageal Junction (ONO-4538-43/CA209577)

A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects with Resected Esophageal, or Gastroesophageal Junction Cancer (ONO-4538-43/CA209577)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223354

Enrollment

760

Registered

2016-10-21

Start date

2017-01-16

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

Esophageal or Gastroesophageal Junction Cancer

Interventions

investigational material(s) Generic name etc : Nivolumab( ONO-4538/BMS-936558 ) INN of investigational material : Nivolumab Therapeutic category code : 429 Other antitumor agents Dosage and Administra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diagnosed with carcinoma of the esophagus or gastroesophageal junction 2. Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection

Exclusion criteria

Exclusion criteria: 1. Diagnosed with cervical esophageal carcinoma 2. Diagnosed with Stage IV resectable disease

Design outcomes

Primary

Measure	Time frame
efficacy Disease-Free Survival	—

Secondary

Measure	Time frame
efficacy Overall survival, Overall survival rate	—

Countries

Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

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