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)
| Registry | NCT06256328 |
|---|---|
| Status | Active not recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: triple, treatment |
| Enrollment | 226 (Actual) |
| Sponsor | Ono Pharmaceutical Co., Ltd. (Industry) |
| Conditions | Gastric Cancer |
| Interventions | ONO-4578, Oxaliplatin, Capecitabine, S-1, Nivolumab, Placebo (Drug) |
| Dates | start 2024-01-10, primary completion 2025-10-09, completion 2027-07-31 (estimated), first posted 2024-02-13, last updated 2026-03-13 |
| Locations | 63 sites in Japan, South Korea, Taiwan |
Related Papers Related Patents Related Grants Related Experts
All trials for Gastric Cancer All trials of ONO-4578 All trials of Oxaliplatin
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| ONO-4578+Nivolumab+chemotherapy | Experimental | Drug: ONO-4578; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab | |
| placebo+Nivolumab+chemotherapy | Placebo comparator | Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab; Drug: Placebo |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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 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 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
| Facility | City | Country | Status |
|---|---|---|---|
| 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 | Taiwan |