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Active, Not Recruiting

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

Updated: 27 May, 2021   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's 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

  • Active, Not Recruiting

Treatment Options

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

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com