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

Completed · Phase 3

Conditions studied: Gastric Cancer, Gastroesophageal Junction Cancer, Esophageal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT02872116

Run by

Bristol-Myers Squibb

People needed

2031

Starts

2016-10-12

Expected to finish

2024-06-06

Last updated by the study team

2025-08-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 apply

Where it is running

• Local Institution - 0001 — San Francisco, California, United States
• Local Institution - 0066 — Aurora, Colorado, United States
• Local Institution - 0151 — Denver, Colorado, United States
• Local Institution - 0136 — Washington D.C., District of Columbia, United States
• Florida Cancer Specialists S. — Fort Myers, Florida, United States
• Local Institution - 0147 — Miami, Florida, United States
• Florida Cancer Specialists — St. Petersburg, Florida, United States
• Local Institution - 0179 — Marietta, Georgia, United States
• Local Institution - 0219 — Arlington Heights, Illinois, United States
• Local Institution - 0120 — Chicago, Illinois, United States
• Local Institution - 0021 — Baltimore, Maryland, United States
• Local Institution - 0002 — Boston, Massachusetts, United States
• Local Institution - 0135 — Boston, Massachusetts, United States
• Local Institution - 0003 — New York, New York, United States
• Local Institution - 0138 — Cleveland, Ohio, United States
• Local Institution - 0186 — Cleveland, Ohio, United States
• Local Institution - 0146 — Eugene, Oregon, United States
• Lehigh Valley Health Network — Allentown, Pennsylvania, United States
• Local Institution - 0065 — Pittsburgh, Pennsylvania, United States
• Local Institution - 0104 — Nashville, Tennessee, United States
• Local Institution - 0140 — Bedford, Texas, United States
• Local Institution - 0143 — Dallas, Texas, United States
• Local Institution - 0213 — Dallas, Texas, United States
• Local Institution - 0004 — Houston, Texas, United States
• Local Institution - 0005 — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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