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 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 Disease control rate (DCR) (site investigator assessment) up to 3 years 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 Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
Taichung Veterans General Hospital
🇨🇳Taichung, Taiwan
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
🇯🇵Minato-ku, Tokyo, Japan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
National Cancer Center Hospital
🇯🇵Chuo-ku, Tokyo, Japan
Taipei Medical University Hospital
🇨🇳Taipei City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Osaki Citizen Hospital
🇯🇵Osaki-shi, Miyagi, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
University of Tokyo Hospital
🇯🇵Bunkyo-ku, Tokyo, Japan
Osaka University Hospital
🇯🇵Suita-shi, Osaka, Japan
Saitama Medical University International Medical Center
🇯🇵Hidaka-shi, Saitama, Japan
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Gangwon-do, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun-gun, Jeollanam-do, Korea, Republic of
Jeonbuk national university hospital
🇰🇷Jeonju-si, Jeollabuk-do, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Gangnam Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Kaohsiung Chang Gung Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chi Mei Hospital, Liouying
🇨🇳Tainan, Taiwan
Far Eastern Memorial Hospital
🇨🇳New Taipei City, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
🇨🇳Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
🇨🇳Taoyuan County, Taiwan
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Saitama Cancer Center
🇯🇵Ina-machi, Kitaadati-gun, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-Cho, Sunto-Gun, Shizuoka, Japan
Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
Keio University Hospital
🇯🇵Shinjyuku-ku, Tokyo, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chung-Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Chang Gung Memorial Hospital, Keelung
🇨🇳Keelung City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
🇨🇳New Taipei City, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Gyeongsangbuk-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of