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



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:1/31/2019
Start Date:June 19, 2017
End Date:December 30, 2021
Contact:Recruiting sites have contact information. Please contact the sites directly. If there is no contact information,
Email:Clinical.Trials@bms.com
Phone:please email:

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A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

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


For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- 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

Exclusion Criteria

- 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 could apply
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