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)

NCT06256328 · tracked via the Priya Life Science China tracker

Sponsor

Ono Pharmaceutical Co., Ltd.

Phase

Phase 2

Started

2024-01-10

Last updated

2026-03-13

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

ONO-4578OxaliplatinCapecitabineS-1NivolumabPlacebo

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

Study 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).

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Progression-free survival (PFS) (site investigator assessment) — up to 2years

Trial sites (63)

Facility	City	Region
Aichi Cancer Center Hospital	Nagoya	Aichi-ken
National Cancer Center Hospital East	Kashiwa-shi	Chiba
Matsuyama Red Cross Hospital	Matsuyama	Ehime
NHO Shikoku Cancer Center	Matsuyama	Ehime
Kyushu University Hospital	Fukuoka	Fukuoka
NHO Kyushu Cancer Center	Fukuoka	Fukuoka
JCHO Kyushu Hospital	Yahatanishi-ku, Kitakyusyu-shi	Fukuoka
Gunma Prefectural Cancer Center	Ota-shi	Gunma
Hiroshima City Hiroshima Citizens Hospital	Hiroshima	Hiroshima
Hyogo Cancer Center	Akashi-shi	Hyōgo
JOHAS Kansai Rosai Hospital	Amagasaki-shi	Hyōgo
Kobe City Hospital Organization Kobe City Medical Center General Hospital	Kobe	Hyōgo
Ibaraki Prefectural Central Hospital	Kasama-shi	Ibaraki
Ishikawa Prefectural Central Hospital	Kanazawa	Ishikawa-ken
Iwate Medical University Hospital	Yahaba-cho, Shiwa-gun	Iwate
Kagawa University Hospital	Miki-cho, Kita-gun	Kagawa-ken
Kitasato University Hospital	Sagamihara-shi	Kanagawa
Kanagawa Cancer Center	Yokohama	Kanagawa
Osaki Citizen Hospital	Osaki-shi	Miyagi
Tohoku University Hospital	Sendai	Miyagi
Kurashiki Central Hospital	Kurashiki-shi	Okayama-ken
Osaka International Cancer Institute	Chuo-ku	Osaka
Kansai Medical University Hospital	Hirakata-shi	Osaka
Osaka Metropolitan University Hospital	Osaka	Osaka
Kindai University Hospital	Sayama-shi	Osaka
Osaka General Medical Center	Sumiyoshi-ku	Osaka
Osaka Medical and Pharmaceutical University Hospital	Takatsuki-shi	Osaka
Saitama Cancer Center	Ina-machi, Kitaadati-gun	Saitama
Shizuoka Cancer Center	Nagaizumi-cho, Sunto-gun	Shizuoka
Cancer Institute Hospital of JFCR	Koto-ku	Tokyo
IMSUT Hospital, The Institute of Medical Science, The University of Tokyo	Minato-Ku	Tokyo
Keio University Hospital	Shinjuku-ku	Tokyo
Kosin University Gospel Hospital	Busan	Gangwon-do
Hallym University Sacred Heart Hospital	Anyang-si	Gyeonggi-do
National Cancer Center	Goyang-si	Gyeonggi-do
CHA Bundang Medical Center, CHA University	Seongnam-si	Gyeonggi-do
Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Ajou University Hospital	Suwon	Gyeonggi-do
The Catholic University of Korea, St. Vincent's Hospital	Suwon	Gyeonggi-do
Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do

+ 23 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile →

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A Retrospective Observational Study of Nivolumab in Combination With Chemotherapy as Neoadjuvant Therapy for Resectable NSCLC Patients: Real-World Experience in Taiwan (NEOREAL) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06256328 on ClinicalTrials.gov ↗ ← All trials in China