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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ONO-4578+Nivolumab+chemotherapy | Experimental |
| |
| placebo+Nivolumab+chemotherapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ONO-4578 | Drug | Specified dose, once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) (site investigator assessment) | up to 2years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | up to 2years | |
| Objective response rate (ORR) (site investigator assessment) | up to 2years | |
| Best overall response (BOR) (site investigator assessment) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Project Leader | Ono Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aichi Cancer Center Hospital | Nagoya | Aichi-ken | Japan | |||
| National Cancer Center Hospital East |
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| Oxaliplatin |
| Drug |
Specified dose on specified days |
|
| Capecitabine | Drug | Specified dose on specified days |
|
| S-1 | Drug | Specified dose on specified days |
|
|
| Nivolumab | Drug | Specified dose on specified days |
|
|
| Placebo | Drug | Specified dose, once daily |
|
| 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 |
| Progression-free survival after the next line of therapy (PFS2) (site investigator assessment) | up to 2years |
| Adverse event (AE) | Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0 | Up to 30 days after the last dose |
| 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 | Taiwan |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D000077150 | Oxaliplatin |
| D000069287 | Capecitabine |
| C079198 | S 1 (combination) |
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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