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)
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT05144854
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 626
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ONO-4538 + ipilimumab + chemotherapy ONO-4538 - ONO-4538 + ipilimumab + chemotherapy Ipilimumab - ONO-4538 + ipilimumab + chemotherapy S-1 - Chemotherapy Oxaliplatin - Chemotherapy Capecitabine - ONO-4538 + ipilimumab + chemotherapy Oxaliplatin - ONO-4538 + ipilimumab + chemotherapy Capecitabine - Chemotherapy S-1 -
- Primary Outcome Measures
Name Time Method Overall survival (OS) up to 3 years
- Secondary Outcome Measures
Name Time Method Disease control rate (DCR) (site investigator assessment) up to 3 years Objective response rate (ORR) (site investigator assessment) up to 3 years Best overall response (BOR) (site investigator assessment) up to 3 years Progression-free survival (PFS) (site investigator assessment) up to 3 years Duration of response (DOR) (site investigator assessment) up to 3 years Time to response (TTR) (site investigator assessment) up to 3 years Adverse event Up to 30 days after the last dose Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) up to 3 years Maximum percent change in the sum diameters of the target lesions (site investigator assessment) up to 3 years
Trial Locations
- Locations (57)
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaki Citizen Hospital
🇯🇵Osaki-shi, Miyagi, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama, Japan
Saitama Cancer Center
🇯🇵Ina-machi, Kitaadati-gun, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-Cho, Sunto-Gun, Shizuoka, Japan
University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Scroll for more (47 remaining)National Cancer Center Hospital East🇯🇵Kashiwa-shi, Chiba, Japan