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Triple therapy aims to outsmart stomach cancer

NCT ID NCT05144854

Disease control Sponsor: Ono Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether adding two immunotherapy drugs (nivolumab and ipilimumab) to standard chemotherapy helps people with advanced HER2-negative stomach or gastroesophageal junction cancer live longer. About 626 participants who have not had prior chemotherapy will receive either the combo or chemo alone. The study is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nivolumab (Opdivo) and ipilimumab (Yervoy) combined with chemotherapy (oxaliplatin, capecitabine, or S-1)
What this could lead to
If successful, this combination could become a new standard first-line treatment for advanced gastric cancer, potentially extending survival.
What could go wrong
This is an early-stage Phase 3 trial; results may not show a significant benefit over chemo alone. Immune-related side effects from nivolumab and ipilimumab can be severe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

626 people

The number who actually took part.

Started

Nov 2021

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm gastroesophageal junction adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, South Korea

  • Asan Medical Center

    Seoul, South Korea

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do, South Korea

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo, Japan

  • Chang Gung Memorial Hospital, Keelung

    Keelung, Taiwan

  • Chang Gung Memorial Hospital,Linkou

    Taoyuan County, Taiwan

  • Chi Mei Hospital, Liouying

    Tainan, Taiwan

  • China Medical University Hospital

    Taichung, Taiwan

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do, South Korea

  • Chung-Ang University Hospital

    Seoul, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, South Korea

  • Chungnam National University Hospital

    Daejeon, South Korea

  • Dong-A University Hospital

    Busan, South Korea

  • Far Eastern Memorial Hospital

    New Taipei City, Taiwan

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do, South Korea

  • IMSUT Hospital, The Institute of Medical Science, The University of Tokyo

    Minato-ku, Tokyo, Japan

  • Inje University Haeundae Paik Hospital

    Busan, South Korea

  • Jeonbuk national university hospital

    Jeonju, Jeollabuk-do, South Korea

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, Japan

  • Kangbuk Samsung Hospital

    Seoul, South Korea

  • Kaohsiung Chang Gung Memorial Hospital

    Kaohsiung City, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, Taiwan

  • Keimyung University Dongsan Hospital

    Daegu, South Korea

  • Keio University Hospital

    Shinjyuku-ku, Tokyo, Japan

  • Konyang University Hospital

    Daejeon, South Korea

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, Taiwan

  • Korea University Guro Hospital

    Seoul, South Korea

  • Kosin University Gospel Hospital

    Busan, Gangwon-do, South Korea

  • Kyungpook National University Chilgok Hospital

    Daegu, Gyeongsangbuk-do, South Korea

  • National Cancer Center

    Goyang-si, Gyeonggi-do, South Korea

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, Japan

  • National Cheng Kung University Hospital

    Tainan, Taiwan

  • National Taiwan University Hospital

    Taipei, Taiwan

  • Osaka University Hospital

    Suita-shi, Osaka, Japan

  • Osaki Citizen Hospital

    Osaki-shi, Miyagi, Japan

  • Pusan National University Hospital

    Busan, South Korea

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do, South Korea

  • Saitama Cancer Center

    Ina-machi, Kitaadati-gun, Saitama, Japan

  • Saitama Medical University International Medical Center

    Hidaka-shi, Saitama, Japan

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, South Korea

  • Seoul National University Hospital

    Seoul, South Korea

  • Severance Hospital, Yonsei University Health System

    Seoul, South Korea

  • Shizuoka Cancer Center

    Nagaizumi-Cho, Sunto-Gun, Shizuoka, Japan

  • Taichung Veterans General Hospital

    Taichung, Taiwan

  • Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare

    New Taipei City, Taiwan

  • Taipei Medical University Hospital

    Taipei, Taiwan

  • Taipei Municipal Wanfang Hospital Managed by Taipei Medical University

    Taipei, Taiwan

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, South Korea

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, South Korea

  • Tri-Service General Hospital

    Taipei, Taiwan

  • Ulsan University Hospital

    Ulsan, South Korea

  • University of Tokyo Hospital

    Bunkyo-ku, Tokyo, Japan

More trials for these conditions

Other studies related to the condition(s) this trial covers.