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.
- Diseases
- Gastric and esophageal cancer
- 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
Sites (57)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Tokyo Hospital Coordinator of this site? Confirm its status | Bunkyo-ku | Japan | Unknown status |
| National Cancer Center Hospital Coordinator of this site? Confirm its status | Chuo Ku | Japan | Unknown status |
| Saitama Medical University International Medical Center Coordinator of this site? Confirm its status | Hidaka-shi | Japan | Unknown status |
| Saitama Cancer Center Coordinator of this site? Confirm its status | Ina-machi, Kitaadati-gun | Japan | Unknown status |
| National Cancer Center Hospital East Coordinator of this site? Confirm its status | Kashiwa-shi | Japan | Unknown status |
| Cancer Institute Hospital of JFCR Coordinator of this site? Confirm its status | Koto-Ku | Japan | Unknown status |
| IMSUT Hospital, The Institute of Medical Science, The University of Tokyo Coordinator of this site? Confirm its status | Minato-ku | Japan | Unknown status |
| Shizuoka Cancer Center Coordinator of this site? Confirm its status | Nagaizumi-cho,Sunto-gun | Japan | Unknown status |
| Osaki Citizen Hospital Coordinator of this site? Confirm its status | Osaki-Shi | Japan | Unknown status |
| Keio University Hospital Coordinator of this site? Confirm its status | Shinjyuku-ku | Japan | Unknown status |
| Osaka University Hospital Coordinator of this site? Confirm its status | Suita-shi | Japan | Unknown status |
| Kanagawa Cancer Center Coordinator of this site? Confirm its status | Yokohama | Japan | Unknown status |
| Hallym University Sacred Heart Hospital Coordinator of this site? Confirm its status | Anyang-si | South Korea | Unknown status |
| Dong-A University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Inje University Haeundae Paik Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kosin University Gospel Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Pusan National University Hospital Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Chungbuk National University Hospital Coordinator of this site? Confirm its status | Cheongju-si | South Korea | Unknown status |
| Keimyung University Dongsan Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Kyungpook National University Chilgok Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| Konyang University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Chonnam National University Hwasun Hospital Coordinator of this site? Confirm its status | Hwasun-gun | South Korea | Unknown status |
| Gachon University Gil Medical Center Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| jeonbuk National University Hospital Coordinator of this site? Confirm its status | Jeonju | South Korea | Unknown status |
| Seoul National University Bundang Hospital Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| CHA Bundang Medical Center, CHA University Coordinator of this site? Confirm its status | Seongnam-si | South Korea | Unknown status |
| Korea University Guro Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Gangnam Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Chung ang University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea St. Vincent's Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ajou University Hospital Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Ulsan University Hospital Coordinator of this site? Confirm its status | Ulsan | South Korea | Unknown status |
| Pusan National University Yangsan Hospital Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
| Kaohsiung Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Keelung Coordinator of this site? Confirm its status | Keelung | Taiwan | Unknown status |
| Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Far Eastern Memorial Hospital Coordinator of this site? Confirm its status | New Taipei City | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| National Cheng Kung University Hospital Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Chi Mei Hospital, Liouying Coordinator of this site? Confirm its status | Tainan | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Medical University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Koo Foundation Sun Yat-Sen Cancer Center Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Tri-Service General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Taipei Municipal Wanfang Hospital (Managed by Taipei Medical University ) Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital, Linkou Coordinator of this site? Confirm its status | Taoyuan County | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.