A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin

Completed · Phase 3

Conditions studied: Various Advanced Cancer

In brief

The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin

Key facts

Study ID

NCT03143153

Run by

Bristol-Myers Squibb

People needed

970

Starts

2017-06-29

Expected to finish

2025-01-13

Last updated by the study team

2026-02-17

Who can join

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

You may qualify if…

• Must have histologically confirmed squamous cell carcinoma or adenosquamous cell carcinoma of esophagus
• Male or Female at least 18 years of age
• Must have esophageal cancer that cannot be operated on, or treated with definitive chemoradiation with curative intent, that is advanced, reoccurring or has spread out
• Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
• Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study

You may not qualify if…

• Presence of tumor cells in the brain or spinal cord which are symptomatic or require treatment
• Active known or suspected autoimmune disease
• Any serious or uncontrolled medical disorder or active infection
• Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
• Any positive test result for hepatitis B or C indicating acute or chronic infection and/or detectable virus
• Other protocol defined inclusion/exclusion criteria apply

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Usc/Norris Comprehensive Cancer Center — Los Angeles, California, United States
• Local Institution - 0188 — Denver, Colorado, United States
• University Of Miami Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Local Institution - 0186 — Miami, Florida, United States
• Local Institution - 0225 — Tampa, Florida, United States
• Local Institution - 0074 — Atlanta, Georgia, United States
• Local Institution - 0032 — Marietta, Georgia, United States
• Hackensack Meridian Jersey Shore University Medical Center — Neptune City, New Jersey, United States
• Oncology Associates Of Oregon, Pc — Eugene, Oregon, United States
• Northwest Cancer Specialists, P.C. — Portland, Oregon, United States
• Local Institution - 0210 — Dallas, Texas, United States
• Local Institution - 0028 — Houston, Texas, United States
• Local Institution - 0190 — Roanoke, Virginia, United States
• Local Institution - 0203 — Morgantown, West Virginia, United States
• Local Institution - 0048 — Buenos Aires, Buenos Aires, Argentina
• Local Institution - 0050 — Capital Federal, Buenos Aires, Argentina
• Local Institution - 0087 — La Rioja, La Rioja Province, Argentina
• Local Institution - 0086 — Rosario, Santa Fe Province, Argentina
• Local Institution - 0232 — Tamworth, New South Wales, Australia
• Local Institution - 0011 — Douglas, Queensland, Australia
• Local Institution - 0010 — Murdoch, Western Australia, Australia
• Local Institution - 0241 — Salzburg, Austria
• Local Institution - 0017 — Salvador, Estado de Bahia, Brazil
• Local Institution - 0191 — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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