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

Completed · Phase 3 · Has a placebo group

Conditions studied: Advanced Cancer

In brief

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

Key facts

Study ID

NCT02743494

Run by

Bristol-Myers Squibb

People needed

794

Starts

2016-07-14

Expected to finish

2024-11-07

Last updated by the study team

2025-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Local Institution - 0026 — Los Angeles, California, United States
• Local Institution - 0023 — San Francisco, California, United States
• Local Institution - 0068 — San Francisco, California, United States
• Local Institution - 0151 — Aurora, Colorado, United States
• Local Institution - 0247 — Denver, Colorado, United States
• Local Institution - 0054 — Washington D.C., District of Columbia, United States
• Local Institution - 0113 — Fort Myers, Florida, United States
• Local Institution - 0131 — Jacksonville, Florida, United States
• Local Institution - 0226 — Miami, Florida, United States
• Local Institution - 0022 — Pensacola, Florida, United States
• Local Institution - 0114 — St. Petersburg, Florida, United States
• Local Institution - 0153 — Chicago, Illinois, United States
• Local Institution - 0025 — Baltimore, Maryland, United States
• Local Institution - 0055 — Boston, Massachusetts, United States
• Local Institution - 0170 — Boston, Massachusetts, United States
• Local Institution - 0171 — Boston, Massachusetts, United States
• Local Institution - 0217 — Boston, Massachusetts, United States
• Local Institution - 0027 — St Louis, Missouri, United States
• Local Institution - 0058 — Hackensack, New Jersey, United States
• Local Institution - 0066 — Neptune City, New Jersey, United States
• Local Institution - 0032 — New York, New York, United States
• Local Institution - 0205 — The Bronx, New York, United States
• Local Institution - 0033 — Charlotte, North Carolina, United States
• Local Institution - 0024 — Durham, North Carolina, United States
• Local Institution - 0250 — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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