A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
About the study
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- Participants who have a life expectancy of at least 3 months
EXCLUSION CRITERIA
Exclusion Criteria:
- Participants with a history or complications of multiple cancers
- Participants with a complication or history of severe hypersensitivity to any other antibody products
- Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Gastric Cancer
Age (in years)
20+
Phase
Phase 3
Participants needed
626
Est. Completion Date
May 31, 2027
Treatment type
Interventional
Sponsor
Ono Pharmaceutical Co. Ltd
ClinicalTrials.gov identifier
NCT05144854
Study number
ONO-4538-113
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