ONO-4538-113: A study to evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy in chemotherapy-naive participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer)

JRCT ID: jRCT2031210458

Registered date:27/11/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Unresectable advanced or recurrent gastric cancer
• Date of first enrollment: 05/11/2021
• Target sample size: 120
• Countries of recruitment: Republic of Korea,Japan,Taiwan,Japan
• Study type: Interventional

Intervention(s)

Study treatment group:ONO-4538 at a dose of 360 mg is intravenously administered once every 3 weeks, and ipilimumab at a dose of 1 mg/kg is intravenously administered once every 6 weeks. As a chemotherapy, oxaliplatin is intravenously administered once, and S-1 combination drug or Capecitabine is orally administered on Day1-14 every 3weeks.
Control group:The same regimen is provided as the chemotherapy on Study treatment group.

Outcome(s)

• Primary Outcome: Overall survival (OS)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
3. Participants who have a life expectancy of at least 3 months

Exclude criteria

1. Participants with a history or complications of multiple cancers
2. Participants with a complication or history of severe hypersensitivity to any other antibody products
3. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease

Related Information

• Primary Sponsor: Hirashima Yoshinori
• Secondary ID(s): NCT05144854