Share Icon Health Study Area: Cardiovascular Disease Chevron Icon Health Study Area: Genitourinary For Patients Health Study Area: Lung Cancer Page Icon Phone Icon For Caregivers Health Study Area: AutoImmune Disease Health Study Area: Melanoma Location Icon Print YouTube Icon For Parents Health Study Area: Lung Cancer Print Created with Sketch. Help Icon Green Check Icon Search Icon Instagram Created with sketchtool. Direction Arrow Icon Error Icon For Parents Health Study Area: Blood Cancer Help Icon Health Study Area: NASH Gender Both Bookmark Icon Health Study Area: Melanoma Created with Sketch. Glossary Print Health Study Area: Blood Cancer Health Study Area: Genitourinary Health Study Area: Gastrointestinal Cancer Mobile Menu Icon Created with Sketch. Health Study Area: Cardiovascular Disease Health Study Area: Women's Cancer Communities Map Icon Created with Sketch. For Caregivers Health Study Area: Fibrosis Health Study Area: AutoImmune Disease FAQs Health Study Area: Head and Neck Cancer Created with Sketch. For Clinicians Chevron Right Icon Gender Female Health Study Area: Breast Cancer Direction Arrow Icon Gender Both Right Arrow Icon LinkedIn Icon Green Check Icon Gender Male Health Study Area: Fibrosis For Patients Twitter Icon Email Icon Facebook Icon Health Study Area: Gastrointestinal Cancer Health Study Area: Head and Neck Cancer For Clinicians External Link Icon

Menu

Search BMS Clinical Trials
BMS Active Not Yet Recruiting Study icon

Active, Not Recruiting

Trial ID CA209-648  |   NCT03143153

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

Warning icon
Sorry, this study is no longer accepting new participants, but is still ongoing.
You may click the “Check if you qualify” button and answer a few questions about your health to find out if you might be a match to another study.
Check if you qualify

Summary

  • Phase 3
  • Male and Female Gender icon
  • 18+
    Age Range
  • BMS Active Not Yet Recruiting Study icon
    Active, Not Recruiting

Overview

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

print Print
email Email

Key Eligibility Criteria

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 apply

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Active Comparator: Cisplatin + Fluorouracil

ASSIGNED INTERVENTION
  • Drug: Cisplatin, Fluorouracil

Study Arms

Experimental: Nivolumab + Cisplatin + Fluorouacil

ASSIGNED INTERVENTION
  • Biological: Nivolumab
  • Drug: Cisplatin, Fluorouracil

Study Arms

Experimental: Nivolumab + Ipilimumab

ASSIGNED INTERVENTION
  • Biological: Nivolumab, Ipilimumab

Help us enhance your website experience! Share your feedback with our team at BMS Clinical Trials to improve yours and others’ experience. Thank you