Overview

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

Status:
Active, not recruiting
Trial end date:
2022-10-06
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bristol-Myers Squibb
Collaborator:
Ono Pharmaceutical Co. Ltd
Treatments:
Antibodies, Monoclonal
Capecitabine
Fluorouracil
Ipilimumab
Leucovorin
Nivolumab
Oxaliplatin
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