A Study to Investigate the Efficacy and Safety of ONO-4578 in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

Last updated: March 4, 2026
Sponsor: Ono Pharmaceutical Co. Ltd
Overall Status: Active - Not Recruiting

Phase

2

Condition

Gastric Cancer

Stomach Cancer

Digestive System Neoplasms

Treatment

Nivolumab

Capecitabine

ONO-4578

Clinical Study ID

NCT06256328
ONO-4578-08
  • Ages > 18
  • All Genders

Study Summary

This study is to compare and evaluate the efficacy and safety of the treatment with ONO-4578 in combination with nivolumab and chemotherapy with those of the treatment with placebo in combination with nivolumab and chemotherapy in chemotherapy-naïve participants with HER2- negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients with gastric or esophagogastric junction cancer histologically diagnosed asadenocarcinoma

  • Patients have not been treated with systemic chemotherapy as first-line therapy

  • Patients who can provide tumor tissue samples

Exclusion

Exclusion Criteria:

  • Patients unable to take oral medicines

  • Patients with HER2-positive

  • Patients with contraindications to nivolumab, oxaliplatin, S-1, or capecitabine

  • Patients who have a history of severe drug-related adverse reactions caused by non-steroidal anti-inflammatory drugs (NSAIDs) or who have complications caused byNSAIDs requiring treatment

  • Patients with concurrent autoimmune disease or a history of chronic or recurrentautoimmune disease, such as rheumatoid arthritis

  • Patients with headache and/or nausea associated with brain metastasis

Study Design

Total Participants: 210
Treatment Group(s): 6
Primary Treatment: Nivolumab
Phase: 2
Study Start date:
January 10, 2024
Estimated Completion Date:
July 31, 2027

Connect with a study center

  • Aichi Cancer Center Hospital

    Nagoya-shi, Aichi
    Japan

    Site Not Available

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken
    Japan

    Site Not Available

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba
    Japan

    Site Not Available

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime
    Japan

    Site Not Available

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime
    Japan

    Site Not Available

  • Matsuyama Red Cross Hospital

    Matsuyama-shi, Ehime
    Japan

    Site Not Available

  • NHO Shikoku Cancer Center

    Matsuyama-shi, Ehime
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka, Fukuoka
    Japan

    Site Not Available

  • NHO Kyushu Cancer Center

    Fukuoka, Fukuoka
    Japan

    Site Not Available

  • Kyushu University Hospital

    Fukuoka-shi, Fukuoka
    Japan

    Site Not Available

  • NHO Kyushu Cancer Center

    Fukuoka-shi, Fukuoka
    Japan

    Site Not Available

  • JCHO Kyushu Hospital

    Yahatanishi-ku, Kitakyusyu-shi, Fukuoka
    Japan

    Site Not Available

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima-shi, Hiroshima
    Japan

    Site Not Available

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe-shi, Hyogo
    Japan

    Site Not Available

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo
    Japan

    Site Not Available

  • JOHAS Kansai Rosai Hospital

    Amagasaki-shi, Hyōgo
    Japan

    Site Not Available

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo
    Japan

    Site Not Available

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki
    Japan

    Site Not Available

  • Ishikawa Prefectural Central Hospital

    Kanazawa-shi, Ishikawa
    Japan

    Site Not Available

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken
    Japan

    Site Not Available

  • Iwate Medical University Hospital

    Yahaba-cho, Shiwa-gun, Iwate
    Japan

    Site Not Available

  • Kagawa University Hospital

    Miki-cho, Kita-gun, Kagawa-ken
    Japan

    Site Not Available

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama, Kanagawa
    Japan

    Site Not Available

  • Kanagawa Cancer Center

    Yokohama-shi, Kanagawa
    Japan

    Site Not Available

  • Osaki Citizen Hospital

    Osaki-shi, Miyagi
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai, Miyagi
    Japan

    Site Not Available

  • Tohoku University Hospital

    Sendai-shi, Miyagi
    Japan

    Site Not Available

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken
    Japan

    Site Not Available

  • Osaka International Cancer Institute

    Chuo-ku, Osaka
    Japan

    Site Not Available

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka
    Japan

    Site Not Available

  • Osaka Metropolitan University Hospital

    Osaka, Osaka
    Japan

    Site Not Available

  • Kindai University Hospital

    Sayama-shi, Osaka
    Japan

    Site Not Available

  • Osaka General Medical Center

    Sumiyoshi-ku, Osaka
    Japan

    Site Not Available

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka
    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

  • 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

    Shinjuku-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

  • 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

  • Keimyung University Dongsan Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Yeungnam University Hospital

    Daegu,
    Korea, Republic of

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    Korea, Republic of

    Site Not Available

  • Inha University Hospital

    Incheon,
    Korea, Republic of

    Site Not Available

  • Asan Medical Center

    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

  • Kyung Hee University Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    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, Eunpyeong St. Mary's Hospital

    Seoul,
    Korea, Republic of

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    Korea, Republic of

    Site Not Available

  • Kosin University Gospel Hospital

    Busan, Gangwon-do
    South Korea

    Site Not Available

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do
    South Korea

    Site Not Available

  • National Cancer Center

    Goyang-si, Gyeonggi-do
    South Korea

    Site Not Available

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do
    South Korea

    Site Not Available

  • Ajou University Hospital

    Suwon, Gyeonggi-do
    South Korea

    Site Not Available

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

    Suwon, Gyeonggi-do
    South Korea

    Site Not Available

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do
    South Korea

    Site Not Available

  • Jeonbuk national university hospital

    Jeonju, Jeollabuk-do
    South Korea

    Site Not Available

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do
    South Korea

    Site Not Available

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong
    South Korea

    Site Not Available

  • Dong-A University Hospital

    Busan,
    South Korea

    Site Not Available

  • Keimyung University Dongsan Hospital

    Daegu,
    South Korea

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu,
    South Korea

    Site Not Available

  • Yeungnam University Hospital

    Daegu,
    South Korea

    Site Not Available

  • Gachon University Gil Medical Center

    Incheon,
    South Korea

    Site Not Available

  • Inha University Hospital

    Incheon,
    South Korea

    Site Not Available

  • Asan Medical Center

    Seoul,
    South Korea

    Site Not Available

  • Kangbuk Samsung Hospital

    Seoul,
    South Korea

    Site Not Available

  • Korea University Guro Hospital

    Seoul,
    South Korea

    Site Not Available

  • Kyung Hee University Hospital

    Seoul,
    South Korea

    Site Not Available

  • Samsung Medical Center

    Seoul,
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul,
    South Korea

    Site Not Available

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

    Seoul,
    South Korea

    Site Not Available

  • Ulsan University Hospital

    Ulsan,
    South Korea

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung,
    Taiwan

    Site Not Available

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City,
    Taiwan

    Site Not Available

  • China Medical University 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

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan District,
    Taiwan

    Site Not Available

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