Gastric CancerPhase 3NCT05144854
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 Phase 3 study testing ONO-4538, Ipilimumab and Oxaliplatin in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 57 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- ONO-4538, Ipilimumab and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 626 participants
- Where
- 57 sitesin 3 countries
- Study dates
- 5 Nov 2021to May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
57 sites in 3 countries.
57 sites in 3 countries
South Korea29 sites
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
Kosin University Gospel Hospital
Busan, Gangwon-do
Dong-A University Hospital
Busan
Inje University Haeundae Paik Hospital
Busan
Pusan National University Hospital
Busan
Chungbuk National University Hospital
Cheongju-si, North Chungcheong
Kyungpook National University Chilgok Hospital
Daegu, Gyeongsangbuk-do
Keimyung University Dongsan Hospital
Daegu
Chungnam National University Hospital
Daejeon
Konyang University Hospital
Daejeon
National Cancer Center
Goyang-si, Gyeonggi-do
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do
Gachon University Gil Medical Center
Incheon
Jeonbuk national university hospital
Jeonju, Jeollabuk-do
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggi-do
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do
Asan Medical Center
Seoul
Chung-Ang University Hospital
Seoul
Gangnam Severance Hospital, Yonsei University Health System
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Guro Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Ajou University Hospital
Suwon, Gyeonggi-do
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do
Ulsan University Hospital
Ulsan
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do
Taiwan16 sites
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
Chang Gung Memorial Hospital, Keelung
Keelung
Far Eastern Memorial Hospital
New Taipei City
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City
China Medical University Hospital
Taichung
Taichung Veterans General Hospital
Taichung
Chi Mei Hospital, Liouying
Tainan
National Cheng Kung University Hospital
Tainan
Koo Foundation Sun Yat-Sen Cancer Center
Taipei
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Municipal Wanfang Hospital Managed by Taipei Medical University
Taipei
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
Chang Gung Memorial Hospital,Linkou
Taoyuan County
Japan12 sites
University of Tokyo Hospital
Bunkyo-ku, Tokyo
National Cancer Center Hospital
Chuo-ku, Tokyo
Saitama Medical University International Medical Center
Hidaka-shi, Saitama
Saitama Cancer Center
Ina-machi, Kitaadati-gun, Saitama
National Cancer Center Hospital East
Kashiwa-shi, Chiba
Cancer Institute Hospital of JFCR
Koto-ku, Tokyo
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
Minato-ku, Tokyo
Shizuoka Cancer Center
Nagaizumi-Cho, Sunto-Gun, Shizuoka
Osaki Citizen Hospital
Osaki-shi, Miyagi
Keio University Hospital
Shinjyuku-ku, Tokyo
Osaka University Hospital
Suita-shi, Osaka
Kanagawa Cancer Center
Yokohama, Kanagawa
About this study
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)
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).
- Conditions
- Gastric Cancer
- Being tested
- ONO-4538, Ipilimumab, Oxaliplatin, Capecitabine, S-1
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4538Drug
Also called Nivolumab, Opdivo
Specified dose on specified days
IpilimumabDrug
Also called BMS-734016, Yervoy
Specified dose on specified days
OxaliplatinDrug
Specified dose on specified days
CapecitabineDrug
Specified dose on specified days
S-1Drug
Also called Tegafur-gimeracil-oteracil potassium
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| ONO-4538 + ipilimumab + chemotherapy | Experimental | Not described Receives: Drug: ONO-4538; Drug: Ipilimumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1 |
| Chemotherapy | Active comparator | Not described Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
(N/A)
Measured: up to 3 years
Secondary outcomes (9)
Progression-free survival (PFS) (site investigator assessment)
(N/A)
Measured: up to 3 years
Objective response rate (ORR) (site investigator assessment)
(N/A)
Measured: up to 3 years
Best overall response (BOR) (site investigator assessment)
(N/A)
Measured: up to 3 years
Duration of response (DOR) (site investigator assessment)
(N/A)
Measured: up to 3 years
Disease control rate (DCR) (site investigator assessment)
(N/A)
Measured: up to 3 years
Time to response (TTR) (site investigator assessment)
(N/A)
Measured: up to 3 years
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
(N/A)
Measured: up to 3 years
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
(N/A)
Measured: up to 3 years
Adverse event
(N/A)
Measured: Up to 30 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2021
- Study start5 Nov 2021
- Primary completion20 Oct 2025
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Project Leader, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05144854
- Sponsor's protocol ID
- ONO-4538-113
- Status last verified
- Jun 2026
- First submitted
- 6 Oct 2021
- Last updated
- 25 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05144854
- Acronym / sponsor ID
- ONO-4538-113
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 626 participants (actual)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Nov 2021 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- May 2027 (estimated)
- First posted
- 3 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-4538 + ipilimumab + chemotherapy | Experimental | Drug: ONO-4538, Drug: Ipilimumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: S-1 |
| Chemotherapy | Active comparator | Drug: Oxaliplatin, Drug: Capecitabine, Drug: S-1 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4538Also: Nivolumab, OpdivoSpecified dose on specified days | Drug | ONO-4538 + ipilimumab + chemotherapy |
| IpilimumabAlso: BMS-734016, YervoySpecified dose on specified days | Drug | ONO-4538 + ipilimumab + chemotherapy |
| OxaliplatinSpecified dose on specified days | Drug | Chemotherapy, ONO-4538 + ipilimumab + chemotherapy |
| CapecitabineSpecified dose on specified days | Drug | Chemotherapy, ONO-4538 + ipilimumab + chemotherapy |
| S-1Also: Tegafur-gimeracil-oteracil potassiumSpecified dose on specified days | Drug | Chemotherapy, ONO-4538 + ipilimumab + chemotherapy |
Primary outcome
Overall survival (OS)
Time frame: up to 3 years
(N/A)
9 secondary outcomes
Progression-free survival (PFS) (site investigator assessment)
Time frame: up to 3 years
Objective response rate (ORR) (site investigator assessment)
Time frame: up to 3 years
Best overall response (BOR) (site investigator assessment)
Time frame: up to 3 years
Duration of response (DOR) (site investigator assessment)
Time frame: up to 3 years
Disease control rate (DCR) (site investigator assessment)
Time frame: up to 3 years
Time to response (TTR) (site investigator assessment)
Time frame: up to 3 years
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
Time frame: up to 3 years
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
Time frame: up to 3 years
Adverse event
Time frame: Up to 30 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Project Leader study director
Ono Pharmaceutical Co., Ltd.
57 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-4538, Ipilimumab and Oxaliplatin in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 57 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 57 sites in South Korea, Taiwan, Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.