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)

Last updated: September 1, 2024
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Not Recruiting

Phase

3

Condition

Gastric Cancer

Digestive System Neoplasms

Stomach Cancer

Treatment

Capecitabine

ONO-4538

Ipilimumab

Clinical Study ID

NCT05144854
ONO-4538-113
  • Ages > 20
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants with unresectable advanced or recurrent gastric cancer (includingesophagogastric junction cancer) that has been histologically confirmed to bepredominant 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

Exclusion Criteria:

  1. Participants with a history or complications of multiple cancers

  2. Participants with a complication or history of severe hypersensitivity to any otherantibody products

  3. Participants with concurrent autoimmune disease or a history of chronic or recurrentautoimmune disease.

Study Design

Total Participants: 626
Treatment Group(s): 5
Primary Treatment: Capecitabine
Phase: 3
Study Start date:
November 05, 2021
Estimated Completion Date:
May 31, 2027

Connect with a study center

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama-shi, Kanagawa
    Japan

    Site Not Available

  • Osaki Citizen Hospital

    Osaki-shi, Miyagi
    Japan

    Site Not Available

  • Osaka University Hospital

    Suita-shi, Osaka
    Japan

    Site Not Available

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama
    Japan

    Site Not Available

  • Saitama Cancer Center

    Ina-machi, Kitaadati-gun, Saitama
    Japan

    Site Not Available

  • Shizuoka Cancer Center

    Nagaizumi-Cho, Sunto-Gun, Shizuoka
    Japan

    Site Not Available

  • University of Tokyo Hospital

    Bunkyo-ku, Tokyo
    Japan

    Site Not Available

  • National Cancer Center Hospital

    Chuo-ku, Tokyo
    Japan

    Site Not Available

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo
    Japan

    Site Not Available

  • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

    Minato-ku, Tokyo
    Japan

    Site Not Available

  • Keio University Hospital

    Shinjyuku-ku, Tokyo
    Japan

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbuk-do
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, Gangwon-do
    Korea, Republic of

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon-si, Gyeonggi-do
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbuk-do
    Korea, Republic of

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan-si, Gyeongsangnam-do
    Korea, Republic of

    Site Not Available

  • Jeonbuk national university hospital

    Jeonju-si, Jeollabuk-do
    Korea, Republic of

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do
    Korea, Republic of

    Site Not Available

  • Dong-A University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan,
    Korea, Republic of

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Chungnam National University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Konyang University Hospital

    Daejeon,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Chung-Ang University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul,
    Korea, Republic of

    Site Not Available

  • Seoul National University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Keelung

    Keelung City,
    Taiwan

    Site Not Available

  • Far Eastern Memorial Hospital

    New Taipei City,
    Taiwan

    Site Not Available

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City,
    Taiwan

    Site Not Available

  • China Medical University Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Taichung Veterans General Hospital

    Taichung,
    Taiwan

    Site Not Available

  • Chi Mei Hospital, Liouying

    Tainan,
    Taiwan

    Site Not Available

  • National Cheng Kung University Hospital

    Tainan,
    Taiwan

    Site Not Available

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Veterans General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Tri-Service General Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Taipei Medical University Hospital

    Taipei City,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan County,
    Taiwan

    Site Not Available

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