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NCT05144854Active, not recruitingPhase 3

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)

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)

Source: ClinicalTrials.gov · Last updated 25 Jun 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
626 (actual)
First submitted
6 Oct 2021
Start date
5 Nov 2021
Primary completion date
20 Oct 2025
Lead sponsor
Ono Pharmaceutical Co., Ltd.
NCT number
NCT05144854

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 626
  • From 5 Nov 2021 to the primary completion date, 20 Oct 2025
  • 57 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.

Other illness

  • Participants with a history or complications of multiple cancers
  • Participants with a complication or history of severe hypersensitivity to any other antibody products

Who the study is looking for

  • 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

Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (57)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Tokyo Hospital
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Bunkyo-kuJapanUnknown status
National Cancer Center Hospital
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Chuo KuJapanUnknown status
Saitama Medical University International Medical Center
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Hidaka-shiJapanUnknown status
Saitama Cancer Center
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Ina-machi, Kitaadati-gunJapanUnknown status
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
Cancer Institute Hospital of JFCR
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Koto-KuJapanUnknown status
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
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Minato-kuJapanUnknown status
Shizuoka Cancer Center
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Nagaizumi-cho,Sunto-gunJapanUnknown status
Osaki Citizen Hospital
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Osaki-ShiJapanUnknown status
Keio University Hospital
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Shinjyuku-kuJapanUnknown status
Osaka University Hospital
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Suita-shiJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Hallym University Sacred Heart Hospital
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Anyang-siSouth KoreaUnknown status
Dong-A University Hospital
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BusanSouth KoreaUnknown status
Inje University Haeundae Paik Hospital
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BusanSouth KoreaUnknown status
Kosin University Gospel Hospital
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BusanSouth KoreaUnknown status
Pusan National University Hospital
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BusanSouth KoreaUnknown status
Chungbuk National University Hospital
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Cheongju-siSouth KoreaUnknown status
Keimyung University Dongsan Hospital
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DaeguSouth KoreaUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
Konyang University Hospital
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DaejeonSouth KoreaUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Chonnam National University Hwasun Hospital
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Hwasun-gunSouth KoreaUnknown status
Gachon University Gil Medical Center
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IncheonSouth KoreaUnknown status
jeonbuk National University Hospital
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JeonjuSouth KoreaUnknown status
Seoul National University Bundang Hospital
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Seongnam-siSouth KoreaUnknown status
CHA Bundang Medical Center, CHA University
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Seongnam-siSouth KoreaUnknown status
Korea University Guro Hospital
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SeoulSouth KoreaUnknown status
Gangnam Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Kangbuk Samsung Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
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SeoulSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Chung ang University Hospital
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SeoulSouth KoreaUnknown status
The Catholic University of Korea St. Vincent's Hospital
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SuwonSouth KoreaUnknown status
Ajou University Hospital
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SuwonSouth KoreaUnknown status
Ulsan University Hospital
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UlsanSouth KoreaUnknown status
Pusan National University Yangsan Hospital
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YangsanSouth KoreaUnknown status
Kaohsiung Chang Gung Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
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Kaohsiung CityTaiwanUnknown status
Chang Gung Memorial Hospital, Keelung
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KeelungTaiwanUnknown status
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
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New Taipei CityTaiwanUnknown status
Far Eastern Memorial Hospital
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New Taipei CityTaiwanUnknown status
Taichung Veterans General Hospital
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TaichungTaiwanUnknown status
China Medical University Hospital
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TaichungTaiwanUnknown status
National Cheng Kung University Hospital
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TainanTaiwanUnknown status
Chi Mei Hospital, Liouying
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TainanTaiwanUnknown status
Taipei Veterans General Hospital
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TaipeiTaiwanUnknown status
National Taiwan University Hospital
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TaipeiTaiwanUnknown status
Taipei Medical University Hospital
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TaipeiTaiwanUnknown status
Koo Foundation Sun Yat-Sen Cancer Center
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TaipeiTaiwanUnknown status
Tri-Service General Hospital
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TaipeiTaiwanUnknown status
Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University )
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TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital, Linkou
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Taoyuan CountyTaiwanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.