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)

March 11, 2026 updated by: Ono Pharmaceutical Co. Ltd

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)

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
226

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan
        • Aichi Cancer Center Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan
        • National Cancer Center Hospital East
    • Ehime
      • Matsuyama, Ehime, Japan
        • Matsuyama Red Cross Hospital
      • Matsuyama, Ehime, Japan
        • NHO Shikoku Cancer Center
    • Fukuoka
      • Fukuoka, Fukuoka, Japan
        • Kyushu University Hospital
      • Fukuoka, Fukuoka, Japan
        • NHO Kyushu Cancer Center
      • Yahatanishi-ku, Kitakyusyu-shi, Fukuoka, Japan
        • JCHO Kyushu Hospital
    • Gunma
      • Ota-shi, Gunma, Japan
        • Gunma Prefectural Cancer Center
    • Hiroshima
      • Hiroshima, Hiroshima, Japan
        • Hiroshima City Hiroshima Citizens Hospital
    • Hyōgo
      • Akashi-shi, Hyōgo, Japan
        • Hyogo Cancer Center
      • Amagasaki-shi, Hyōgo, Japan
        • JOHAS Kansai Rosai Hospital
      • Kobe, Hyōgo, Japan
        • Kobe City Hospital Organization Kobe City Medical Center General Hospital
    • Ibaraki
      • Kasama-shi, Ibaraki, Japan
        • Ibaraki Prefectural Central Hospital
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan
        • Ishikawa Prefectural Central Hospital
    • Iwate
      • Yahaba-cho, Shiwa-gun, Iwate, Japan
        • Iwate Medical University Hospital
    • Kagawa-ken
      • Miki-cho, Kita-gun, Kagawa-ken, Japan
        • Kagawa University Hospital
    • Kanagawa
      • Sagamihara-shi, Kanagawa, Japan
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan
        • Kanagawa Cancer Center
    • Miyagi
      • Osaki-shi, Miyagi, Japan
        • Osaki Citizen Hospital
      • Sendai, Miyagi, Japan
        • Tohoku University Hospital
    • Okayama-ken
      • Kurashiki-shi, Okayama-ken, Japan
        • Kurashiki Central Hospital
    • Osaka
      • Chuo-ku, Osaka, Japan
        • Osaka International Cancer Institute
      • Hirakata-shi, Osaka, Japan
        • Kansai Medical University Hospital
      • Osaka, Osaka, Japan
        • Osaka Metropolitan university Hospital
      • Sayama-shi, Osaka, Japan
        • Kindai University Hospital
      • Sumiyoshi-ku, Osaka, Japan
        • Osaka General Medical Center
      • Takatsuki-shi, Osaka, Japan
        • Osaka Medical and Pharmaceutical University Hospital
    • Saitama
      • Ina-machi, Kitaadati-gun, Saitama, Japan
        • Saitama Cancer Center
    • Shizuoka
      • Nagaizumi-cho, Sunto-gun, Shizuoka, Japan
        • Shizuoka Cancer Center
    • Tokyo
      • Koto-ku, Tokyo, Japan
        • Cancer Institute Hospital of JFCR
      • Minato-Ku, Tokyo, Japan
        • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo
      • Shinjuku-ku, Tokyo, Japan
        • Keio university hospital
  • South Korea
      • Busan, South Korea
        • Dong-A University Hospital
      • Daegu, South Korea
        • Kyungpook National University Chilgok Hospital
      • Daegu, South Korea
        • Keimyung University Dongsan Hospital
      • Daegu, South Korea
        • Yeungnam University Hospital
      • Incheon, South Korea
        • Gachon University Gil Medical Center
      • Incheon, South Korea
        • Inha University Hospital
      • Seoul, South Korea
        • Asan Medical Center
      • Seoul, South Korea
        • Kangbuk Samsung Hospital
      • Seoul, South Korea
        • Korea University Guro 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
        • Kyung Hee University Hospital
      • Ulsan, South Korea
        • Ulsan University Hospital
    • Gangwon-do
      • Busan, Gangwon-do, South Korea
        • Kosin university gospel hospital
    • Gyeonggi-do
      • Anyang-si, Gyeonggi-do, South Korea
        • Hallym University Sacred Heart Hospital
      • Goyang-si, Gyeonggi-do, South Korea
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, South Korea
        • Seoul National University Bundang Hospital
      • Seongnam-si, Gyeonggi-do, South Korea
        • CHA Bundang Medical Center, CHA University
      • Suwon, Gyeonggi-do, South Korea
        • Ajou University Hospital
      • Suwon, Gyeonggi-do, South Korea
        • The Catholic University Of Korea, St. Vincent's Hospital
    • Gyeongsangnam-do
      • Yangsan, Gyeongsangnam-do, South Korea
        • Pusan National University Yangsan Hospital
    • Jeollabuk-do
      • Jeonju, Jeollabuk-do, South Korea
        • Jeonbuk National University Hospital
    • Jeollanam-do
      • Hwasun-gun, Jeollanam-do, South Korea
        • Chonnam National University Hwasun Hospital
    • North Chungcheong
      • Cheongju-si, North Chungcheong, South Korea
        • Chungbuk National University Hospital
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Tainan, Taiwan
        • Chi Mei Hospital, Liouying
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taoyuan District, Taiwan
        • Chang Gung Memorial Hospital, Linkou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ONO-4578+Nivolumab+chemotherapy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Drug: S-1
Specified dose on specified days
Other Names:
  • Tegafur-gimeracil-oteracil potassium
Drug: ONO-4578
Specified dose, once daily
Placebo Comparator: placebo+Nivolumab+chemotherapy
Drug: Nivolumab
Specified dose on specified days
Other Names:
  • Opdivo
Drug: Oxaliplatin
Specified dose on specified days
Drug: Capecitabine
Specified dose on specified days
Drug: S-1
Specified dose on specified days
Other Names:
  • Tegafur-gimeracil-oteracil potassium
Drug: Placebo
Specified dose, once daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Progression-free survival (PFS) (site investigator assessment)
Time Frame: up to 2years
up to 2years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall survival (OS)
Time Frame: up to 2years
up to 2years
Objective response rate (ORR) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Best overall response (BOR) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Duration of response (DOR) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Disease control rate (DCR) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Time to response (TTR) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Maximum percent change in the sum diameters of the target lesions (site investigator assessment)
Time Frame: up to 2years
up to 2years
Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)
Time Frame: up to 2years
up to 2years
Adverse event (AE)
Time Frame: Up to 30 days after the last dose
Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0
Up to 30 days after the last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ono Pharmaceutical Co. Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Project Leader, Ono Pharmaceutical Co. Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 9, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ONO-4578-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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