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)
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)
1 other identifier
interventional
226
3 countries
63
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 gastric-cancer
Started Jan 2024
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2024
CompletedFirst Submitted
Initial submission to the registry
January 23, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 9, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
ExpectedMarch 13, 2026
March 1, 2026
1.7 years
January 23, 2024
March 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS) (site investigator assessment)
up to 2years
Secondary Outcomes (9)
Overall survival (OS)
up to 2years
Objective response rate (ORR) (site investigator assessment)
up to 2years
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
- +4 more secondary outcomes
Study Arms (2)
ONO-4578+Nivolumab+chemotherapy
EXPERIMENTALplacebo+Nivolumab+chemotherapy
PLACEBO COMPARATORInterventions
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Project Leader
Ono Pharmaceutical Co. Ltd
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2024
First Posted
February 13, 2024
Study Start
January 10, 2024
Primary Completion
October 9, 2025
Study Completion (Estimated)
July 31, 2027
Last Updated
March 13, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share