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Recruiting

Efficacy Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Against Chemotherapy in Stomach Cancer or Stomach/Esophagus Junction Cancer - CA209-649

Updated: 10 September, 2018   |   ClinicalTrials.gov

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the trial guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 3

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 73

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Active Comparator: FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin
Experimental: Nivolumab + FOLFOX
Drug: Nivolumab Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin
Experimental: Nivolumab + Ipilimumab
Drug: Nivolumab Drug: Ipilimumab
Experimental: Nivolumab + XELOX
Drug: Nivolumab Drug: Capecitabine Drug: Oxaliplatin
Active Comparator: XELOX (Oxaliplatin + Capecitabine)
Drug: Oxaliplatin Drug: Capecitabine

Key Eligibility Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: - Male or Female at least 18 years of age - Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out - Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months - 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 that have not been treated - 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 Other protocol defined inclusion/exclusion criteria could apply

Have questions? Call 855-907-3286 or Email Us

Have questions?
Call 855-907-3286 or Email Us