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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

Trial Status: Closed to Accrual

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

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

Arizona

Tucson
Banner University Medical Center - Tucson
Status: ACTIVE

California

Los Angeles
USC / Norris Comprehensive Cancer Center
Status: ACTIVE
Contact: Marile Garcia Leiva
Phone: 323-865-0465

Florida

Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: ACTIVE
Tampa
Moffitt Cancer Center
Status: CLOSED_TO_ACCRUAL

Georgia

Atlanta
Emory University Hospital / Winship Cancer Institute
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Emory University Hospital Midtown
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION
Contact: Nabil F. Saba

Texas

Houston
M D Anderson Cancer Center
Status: ACTIVE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Bristol-Myers Squibb

  • Primary ID CA209-648
  • Secondary IDs NCI-2017-00937, 2016-001514-20
  • Clinicaltrials.gov ID NCT03143153