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)
- Conditions
- Gastric Cancer
- Interventions
- Registration Number
- NCT06256328
- Lead Sponsor
- Ono Pharmaceutical Co. Ltd
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 210
- Patients with gastric or esophagogastric junction cancer histologically diagnosed as adenocarcinoma
- Patients have not been treated with systemic chemotherapy as first-line therapy
- Patients who can provide tumor tissue samples
- 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 by NSAIDs requiring treatment
- Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease, such as rheumatoid arthritis
- Patients with headache and/or nausea associated with brain metastasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo+Nivolumab+chemotherapy Capecitabine - placebo+Nivolumab+chemotherapy Placebo - ONO-4578+Nivolumab+chemotherapy ONO-4578 - ONO-4578+Nivolumab+chemotherapy Oxaliplatin - placebo+Nivolumab+chemotherapy Nivolumab - ONO-4578+Nivolumab+chemotherapy Nivolumab - ONO-4578+Nivolumab+chemotherapy Capecitabine - ONO-4578+Nivolumab+chemotherapy S-1 - placebo+Nivolumab+chemotherapy Oxaliplatin - placebo+Nivolumab+chemotherapy S-1 -
- Primary Outcome Measures
Name Time Method Progression-free survival (PFS) (site investigator assessment) up to 2years
- Secondary Outcome Measures
Name Time Method Objective response rate (ORR) (site investigator assessment) up to 2years Overall survival (OS) up to 2years Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) up to 2years Adverse event (AE) Up to 30 days after the last dose Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Best overall response (BOR) (site investigator assessment) up to 2years Duration of response (DOR) (site investigator assessment) up to 2years Disease control rate (DCR) (site investigator assessment) up to 2years Time to response (TTR) (site investigator assessment) up to 2years Maximum percent change in the sum diameters of the target lesions (site investigator assessment) up to 2years
Trial Locations
- Locations (63)
Chungbuk National University Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
CHA Bundang Medical Center, CHA University
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun-gun, Jeollanam-do, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Aichi Cancer Center Hospital
🇯🇵Nagoya-shi, Aichi, Japan
National Cancer Center Hospital East
🇯🇵Kashiwa-shi, Chiba, Japan
Matsuyama Red Cross Hospital
🇯🇵Matsuyama-shi, Ehime, Japan
NHO Kyushu Cancer Center
🇯🇵Fukuoka-shi, Fukuoka, Japan
NHO Shikoku Cancer Center
🇯🇵Matsuyama-shi, Ehime, Japan
Kyushu University Hospital
🇯🇵Fukuoka-shi, Fukuoka, Japan
JCHO Kyushu Hospital
🇯🇵Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, Japan
Hiroshima City Hiroshima Citizens Hospital
🇯🇵Hiroshima-shi, Hiroshima, Japan
Gunma Prefectural Cancer Center
🇯🇵Ota-shi, Gunma, Japan
Hyogo Cancer Center
🇯🇵Akashi-shi, Hyogo, Japan
Kobe City Hospital Organization Kobe City Medical Center General Hospital
🇯🇵Kobe-shi, Hyogo, Japan
JOHAS Kansai Rosai Hospital
🇯🇵Amagasaki-shi, Hyougo, Japan
Ibaraki Prefectural Central Hospital
🇯🇵Kasama-shi, Ibaraki, Japan
Ishikawa Prefectural Central Hospital
🇯🇵Kanazawa-shi, Ishikawa, Japan
Kitasato University Hospital
🇯🇵Sagamihara-shi, Kanagawa, Japan
Kagawa University Hospital
🇯🇵Miki-cho, Kita-gun, Kagawa, Japan
Kanagawa Cancer Center
🇯🇵Yokohama-shi, Kanagawa, Japan
Osaki Citizen Hospital
🇯🇵Osaki-shi, Miyagi, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Miyagi, Japan
Kurashiki Central Hospital
🇯🇵Kurashiki-shi, Okayama, Japan
Osaka International Cancer Institute
🇯🇵Chuo-ku, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Takatsuki-shi, Osaka, Japan
Kansai Medical University Hospital
🇯🇵Hirakata-shi, Osaka, Japan
Osaka General Medical Center
🇯🇵Sumiyoshi-ku, Osaka, Japan
Kindai University Hospital
🇯🇵Sayama-shi, Osaka, Japan
Saitama Cancer Center
🇯🇵Ina-machi, Kitaadati-gun, Saitama, Japan
Shizuoka Cancer Center
🇯🇵Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
Keio University Hospital
🇯🇵Shinjuku-ku, Tokyo, Japan
Osaka Metropolitan University Hospital
🇯🇵Osaka, Japan
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan-si, Gyeongsangnam-do, Korea, Republic of
Jeonbuk national university hospital
🇰🇷Jeonju-si, Jeollabuk-do, Korea, Republic of
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Yeungnam University Hospital
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Hospital
🇰🇷Daegu, Korea, Republic of
Kyungpook National University Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Inha University Hospital
🇰🇷Incheon, Korea, Republic of
Kangbuk Samsung Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital, Yonsei University Health System
🇰🇷Seoul, Korea, Republic of
Chi Mei Hospital, Liouying
🇨🇳Tainan, Taiwan
Chang Gung Memorial Hospital, Linkou
🇨🇳Taoyuan, Taiwan
Iwate Medical University Hospital
🇯🇵Yahaba-cho, Shiwa-gun, Iwate, Japan
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang-si, Gyeonggi-do, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Gangwon-do, Korea, Republic of
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
National Cheng Kung University Hospital
🇨🇳Tainan, Taiwan
China Medical University Hospital
🇨🇳Taichung, Taiwan
Cancer Institute Hospital of JFCR
🇯🇵Koto-ku, Tokyo, Japan
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
🇯🇵Minato-Ku, Tokyo, Japan
National Taiwan University Hospital
🇨🇳Taipei, Taiwan