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
We found this trial at
20
sites
Atlanta, Georgia 30322
Phone: 404-686-1855
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Austin, Texas 78701
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2061 Avenida Caseros
Capital Federal, Buenos Aires C1264
Phone: +541149821731
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Capital Federal,
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Chicago, Illinois 60637
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Dallas, Texas 75246
Phone: 281-863-6662
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Denver, Colorado 80218
Phone: 281-863-6662
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Durham, North Carolina 27710
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Eugene, Oregon 97401
Phone: 281-863-6662
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Phone: 713-745-3917
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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1441 Eastlake Ave
Los Angeles, California 90033
(323) 865-3000
Phone: 323-865-0463
U.S.C./Norris Comprehensive Cancer Center The USC Norris Comprehensive Cancer Center, located in Los Angeles, is...
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Marietta, Georgia 30060
Phone: 770-281-5124
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Marietta, GA
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Miami, Florida 33176
Phone: 281-863-6662
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1475 NW 12th Ave
Miami, Florida 33136
(305) 243-1000
Phone: 305-243-0116
University of Miami, Sylvester Comprehensive Cancer Center Sylvester Comprehensive Cancer Center integrates all cancer-related activities...
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Mobile, Alabama 36608
Phone: 281-863-6662
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Morgantown, West Virginia 26506
Phone: 304-293-2633
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Neptune, New Jersey 07754
Phone: 732-776-3885
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Portland, Oregon 97213
Phone: 281-863-6662
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Roanoke, Virginia 24014
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Tampa, Florida 33612
Phone: 813-745-4398
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Tucson, Arizona
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