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Active, not recruitingNCT05144854Updated Jun 25, 2026

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 interventional study of ONO-4538 and Ipilimumab in Gastric Cancer, sponsored by Ono Pharmaceutical Co., Ltd.. Active, not recruiting at 57 sites in 3 countries. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.

Sponsored by Ono Pharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
626
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 626 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Ono Pharmaceutical Co., Ltd. is the lead sponsor of 43 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
  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

Exclusion Criteria:

  1. Participants with a history or complications of multiple cancers
  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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
626 participants (actual)

Study arms

  • Experimental
    ONO-4538 + ipilimumab + chemotherapy

    Drug: ONO-4538 · Drug: Ipilimumab · Drug: Oxaliplatin · Drug: Capecitabine · Drug: S-1

  • Active comparator
    Chemotherapy

    Drug: Oxaliplatin · Drug: Capecitabine · Drug: S-1

Interventions

  • DrugONO-4538

    Specified dose on specified days

    Also known as: Nivolumab, Opdivo

  • DrugIpilimumab

    Specified dose on specified days

    Also known as: BMS-734016, Yervoy

  • DrugOxaliplatin

    Specified dose on specified days

  • DrugCapecitabine

    Specified dose on specified days

  • DrugS-1

    Specified dose on specified days

    Also known as: Tegafur-gimeracil-oteracil potassium

06

What researchers measure

Primary outcomes

  1. Overall survival (OS)

    (N/A)

    Time frame: up to 3 years

Secondary outcomes

  1. Progression-free survival (PFS) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  2. Objective response rate (ORR) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  3. Best overall response (BOR) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  4. Duration of response (DOR) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  5. Disease control rate (DCR) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  6. Time to response (TTR) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  7. Maximum percent change in the sum diameters of the target lesions (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  8. Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)

    (N/A)

    Time frame: up to 3 years

  9. Adverse event

    (N/A)

    Time frame: Up to 30 days after the last dose

07

Study locations

57 sites
  • 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 County, Taiwan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05144854
Lead sponsor
Ono Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Dec 3, 2021
Start date
Nov 5, 2021
Primary completion
Oct 20, 2025
Completion
May 2027 (estimated)
Last update
Jun 25, 2026

Study contacts

Project Leader
study director · Ono Pharmaceutical Co., Ltd.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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