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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)
Sponsor: Ono Pharmaceutical Co. Ltd
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).
Official title: A Randomized, Multicenter, Double-blind, Phase II Study to Compare the Efficacy and Safety of the Treatment With ONO-4578 in Combination With Nivolumab, Fluoropyrimidine-based and Platinum- Based Chemotherapy (Hereinafter Referred to as Chemotherapy) With Those of the Treatment With Placebo in Combination With Nivolumab and Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
226
Start Date
2024-01-10
Completion Date
2027-07-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
ONO-4578
Specified dose, once daily
Oxaliplatin
Specified dose on specified days
Capecitabine
Specified dose on specified days
S-1
Specified dose on specified days
Nivolumab
Specified dose on specified days
Placebo
Specified dose, once daily
Locations (63)
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Matsuyama Red Cross Hospital
Matsuyama, Ehime, Japan
NHO Shikoku Cancer Center
Matsuyama, Ehime, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
NHO Kyushu Cancer Center
Fukuoka, Fukuoka, Japan
JCHO Kyushu Hospital
Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, Japan
Gunma Prefectural Cancer Center
Ota-shi, Gunma, Japan
Hiroshima City Hiroshima Citizens Hospital
Hiroshima, Hiroshima, Japan
Hyogo Cancer Center
Akashi-shi, Hyōgo, Japan
JOHAS Kansai Rosai Hospital
Amagasaki-shi, Hyōgo, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
Kobe, Hyōgo, Japan
Ibaraki Prefectural Central Hospital
Kasama-shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
Kanazawa, Ishikawa-ken, Japan
Iwate Medical University Hospital
Yahaba-cho, Shiwa-gun, Iwate, Japan
Kagawa University Hospital
Miki-cho, Kita-gun, Kagawa-ken, Japan
Kitasato University Hospital
Sagamihara-shi, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Osaki Citizen Hospital
Osaki-shi, Miyagi, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kurashiki Central Hospital
Kurashiki-shi, Okayama-ken, Japan
Osaka International Cancer Institute
Chuo-ku, Osaka, Japan
Kansai Medical University Hospital
Hirakata-shi, Osaka, Japan
Osaka Metropolitan University Hospital
Osaka, Osaka, Japan
Kindai University Hospital
Sayama-shi, Osaka, Japan
Osaka General Medical Center
Sumiyoshi-ku, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-shi, Osaka, Japan
Saitama Cancer Center
Ina-machi, Kitaadati-gun, Saitama, Japan
Shizuoka Cancer Center
Nagaizumi-cho, Sunto-gun, Shizuoka, 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
Shinjuku-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
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
Keimyung University Dongsan Hospital
Daegu, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Yeungnam University Hospital
Daegu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Inha University Hospital
Incheon, South Korea
Asan Medical Center
Seoul, South Korea
Kangbuk Samsung Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
Kyung Hee University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Ulsan University Hospital
Ulsan, South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan District, Taiwan