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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)
Sponsor: Ono Pharmaceutical Co. Ltd
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).
Official title: A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Key Details
Gender
All
Age Range
20 Years - Any
Study Type
INTERVENTIONAL
Enrollment
626
Start Date
2021-11-05
Completion Date
2027-05
Last Updated
2024-09-05
Healthy Volunteers
No
Conditions
Interventions
ONO-4538
Specified dose on specified days
Ipilimumab
Specified dose on specified days
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
S-1
Specified dose on specified days
Locations (57)
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Kanagawa Cancer Center
Yokohama, 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
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo, Japan
Keio University Hospital
Shinjyuku-ku, Tokyo, Japan
Kosin University Gospel Hospital
Busan, Gangwon-do, South Korea
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, South Korea
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbuk-do, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, South Korea
Jeonbuk national university hospital
Jeonju, Jeollabuk-do, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea
Chungbuk National University Hospital
Cheongju-si, North Chungcheong, South Korea
Dong-A University Hospital
Busan, South Korea
Inje University Haeundae Paik Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Chungnam National University Hospital
Daejeon, South Korea
Konyang University Hospital
Daejeon, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Chung-Ang University Hospital
Seoul, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital, Keelung
Keelung, Taiwan
Far Eastern Memorial Hospital
New Taipei City, Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital,Linkou
Taoyuan, Taiwan