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

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About the study

The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


  1. Male or Female at least 18 years of age
  2. Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
  3. Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
  4. 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
  5. 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

Exclusion Criteria:


  1. Presence of tumor cells in the brain or spinal cord that have not been treated
  2. Active known or suspected autoimmune disease
  3. Any serious or uncontrolled medical disorder or active infection
  4. Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  5. Any positive test result for hepatitis B or C indicating acute or chronic infection

Other protocol-defined inclusion/exclusion criteria apply


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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.

Study’s details


Contition
Gastric Cancer,Gastroesophageal Junction Cancer,Esophageal Adenocarcinoma
Age (in years)
18+
Phase
Phase 3
Participants needed
2031
Est. Completion Date
May 31, 2024
Treatment type
Interventional

Sponsor
Bristol-Myers Squibb
ClinicalTrials.gov identifier
NCT02872116
Study number
CA209649

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