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)
NCT ID: NCT05144854
Last Updated: 2024-09-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
626 participants
INTERVENTIONAL
2021-11-05
2027-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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ONO-4538 + ipilimumab + chemotherapy
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
Chemotherapy
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
S-1
Specified dose on specified days
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
Exclusion Criteria
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.
20 Years
ALL
No
Sponsors
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Ono Pharmaceutical Co. Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Project Leader
Role: STUDY_DIRECTOR
Ono Pharmaceutical Co. Ltd
Locations
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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 City, , Taiwan
National Cheng Kung University Hospital
Tainan City, , 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
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
Countries
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Other Identifiers
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ONO-4538-113
Identifier Type: -
Identifier Source: org_study_id
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