Active, Not Recruiting

Trial ID CA209-577 | NCT02743494

An Investigational Immuno-therapy Study of Nivolumab or Placebo in Participants With Resected Esophageal or Gastroesophageal Junction Cancer

Sorry, this study is no longer accepting new participants, but is still ongoing.

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About This Trial
Key Eligibility Criteria

Summary

Phase 3
18+

Age Range
Active, Not Recruiting

Overview

The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.

Key Eligibility Criteria

Inclusion Criteria: - Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction - Completed pre-operative chemo radiotherapy followed by surgery - Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection Exclusion Criteria: - Diagnosed with cervical esophageal carcinoma - Diagnosed with Stage IV resectable disease - Did not receive concurrent chemoradiotherapy prior to surgery - Participants who have received a live/attenuated vaccine within 30 days of the first treatment Other protocol defined Inclusion/exclusion criteria could apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Nivolumab

ASSIGNED INTERVENTION

Drug: Nivolumab

Study Arms

Placebo Comparator: Placebo

ASSIGNED INTERVENTION

Other: Placebo