A Study to Evaluate the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab and Chemotherapy in Chemotherapy-naïve Participants With HER2-negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)

NCT05144854 · tracked via the Priya Life Science Japan tracker

Sponsor

Ono Pharmaceutical Co., Ltd

Phase

Phase 3

Started

2021-11-05

Last updated

2026-06-25

Condition(s) studied

Gastric Cancer

Investigational drug(s) / intervention(s)

ONO-4538 →Ipilimumab →Oxaliplatin →Capecitabine →S-1 →

ONO-4538: Specified dose on specified days

Ipilimumab: Specified dose on specified days

Oxaliplatin: Specified dose on specified days

Capecitabine: Specified dose on specified days

S-1: Specified dose on specified days

Study summary

This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).

Eligibility

Sex

ALL

Min age

20 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma 2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1 3. Participants who have a life expectancy of at least 3 months Exclusion Criteria: 1. Participants with a history or complications of multiple cancers 2. Participants with a complication or history of severe hypersensitivity to any other antibody products 3. Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.

Primary outcome measure(s)

Overall survival (OS) — up to 3 years
(N/A)

Trial sites (57)

Facility	City	Region
National Cancer Center Hospital East	Kashiwa-shi	Chiba
Kanagawa Cancer Center	Yokohama	Kanagawa
Osaki Citizen Hospital	Osaki-shi	Miyagi
Osaka University Hospital	Suita-shi	Osaka
Saitama Medical University International Medical Center	Hidaka-shi	Saitama
Saitama Cancer Center	Ina-machi, Kitaadati-gun	Saitama
Shizuoka Cancer Center	Nagaizumi-Cho, Sunto-Gun	Shizuoka
University of Tokyo Hospital	Bunkyo-ku	Tokyo
National Cancer Center Hospital	Chuo-ku	Tokyo
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	Shinjyuku-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
Kyungpook National University Chilgok Hospital	Daegu	Gyeongsangbuk-do
Pusan National University Yangsan Hospital	Yangsan	Gyeongsangnam-do
Jeonbuk national university hospital	Jeonju	Jeollabuk-do
Chonnam National University Hwasun Hospital	Hwasun-gun	Jeollanam-do
Chungbuk National University Hospital	Cheongju-si	North Chungcheong
Dong-A University Hospital	Busan	South Korea
Inje University Haeundae Paik Hospital	Busan	South Korea
Pusan National University Hospital	Busan	South Korea
Keimyung University Dongsan Hospital	Daegu	South Korea
Chungnam National University Hospital	Daejeon	South Korea
Konyang University Hospital	Daejeon	South Korea
Gachon University Gil Medical Center	Incheon	South Korea
Asan Medical Center	Seoul	South Korea
Chung-Ang University Hospital	Seoul	South Korea
Gangnam Severance Hospital, Yonsei University Health System	Seoul	South Korea
Kangbuk Samsung Hospital	Seoul	South Korea
Korea University Guro Hospital	Seoul	South Korea
Samsung Medical Center	Seoul	South Korea
Seoul National University Hospital	Seoul	South Korea
Severance Hospital, Yonsei University Health System	Seoul	South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul	South Korea

+ 17 more sites — see the full list on the official registry below.

More Ono Pharmaceutical Co., Ltd. trials in Japan

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors Active, not recruiting

INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV) Recruiting

A Study of ONO-3310 in Healthy Adult Male Subjects and Chronic Kidney Disease Patients With Type 2 Diabetes Mellitus Recruiting

A Study of ONO-7428 in Participants With Unresectable Advanced or Recurrent Solid Tumors Active, not recruiting

A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. Recruiting

Other trials for the same condition

Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Recruiting

A Study of Zolbetuximab (IMAB362) in Adults With Gastric Cancer Active, not recruiting

A Study of Evorpacept (ALX148) in Patients With Advanced HER2+ Gastric Cancer (ASPEN-06) Active, not recruiting

A Study of MT-4561 in Patients With Various Advanced Solid Tumors Recruiting

AZD0901 Compared With Investigator's Choice of Therapy in Participants With Second- or Later-line Advanced or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Expressing Claudin18.2 Active, not recruiting

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 NCT05144854 on ClinicalTrials.gov ↗ ← All trials in Japan