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Gastric CancerPhase 2NCT06256328

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 Phase 2 study testing ONO-4578, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 63 sites in 3 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
ONO-4578, Oxaliplatin and Capecitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
226 participants
Where
63 sitesin 3 countries
Study dates
10 Jan 2024to 31 Jul 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

63 sites in 3 countries.

63 sites in 3 countries

Japan32 sites

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo

  • JOHAS Kansai Rosai Hospital

    Amagasaki-shi, Hyōgo

  • Osaka International Cancer Institute

    Chuo-ku, Osaka

  • Kyushu University Hospital

    Fukuoka, Fukuoka

  • NHO Kyushu Cancer Center

    Fukuoka, Fukuoka

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka

  • Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, Hiroshima

  • Saitama Cancer Center

    Ina-machi, Kitaadati-gun, Saitama

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken

  • Ibaraki Prefectural Central Hospital

    Kasama-shi, Ibaraki

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba

  • Kobe City Hospital Organization Kobe City Medical Center General Hospital

    Kobe, Hyōgo

  • Cancer Institute Hospital of JFCR

    Koto-ku, Tokyo

  • Kurashiki Central Hospital

    Kurashiki-shi, Okayama-ken

  • Matsuyama Red Cross Hospital

    Matsuyama, Ehime

  • NHO Shikoku Cancer Center

    Matsuyama, Ehime

  • Kagawa University Hospital

    Miki-cho, Kita-gun, Kagawa-ken

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

    Minato-Ku, Tokyo

  • Shizuoka Cancer Center

    Nagaizumi-cho, Sunto-gun, Shizuoka

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken

  • Osaka Metropolitan University Hospital

    Osaka, Osaka

  • Osaki Citizen Hospital

    Osaki-shi, Miyagi

  • Gunma Prefectural Cancer Center

    Ota-shi, Gunma

  • Kitasato University Hospital

    Sagamihara-shi, Kanagawa

  • Kindai University Hospital

    Sayama-shi, Osaka

  • Tohoku University Hospital

    Sendai, Miyagi

  • Keio University Hospital

    Shinjuku-ku, Tokyo

  • Osaka General Medical Center

    Sumiyoshi-ku, Osaka

  • Osaka Medical and Pharmaceutical University Hospital

    Takatsuki-shi, Osaka

  • Iwate Medical University Hospital

    Yahaba-cho, Shiwa-gun, Iwate

  • JCHO Kyushu Hospital

    Yahatanishi-ku, Kitakyusyu-shi, Fukuoka

  • Kanagawa Cancer Center

    Yokohama, Kanagawa

Other trials in Japan

South Korea25 sites

  • Hallym University Sacred Heart Hospital

    Anyang-si, Gyeonggi-do

  • Kosin University Gospel Hospital

    Busan, Gangwon-do

  • Dong-A University Hospital

    Busan

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong

  • Keimyung University Dongsan Hospital

    Daegu

  • Kyungpook National University Chilgok Hospital

    Daegu

  • Yeungnam University Hospital

    Daegu

  • National Cancer Center

    Goyang-si, Gyeonggi-do

  • Chonnam National University Hwasun Hospital

    Hwasun-gun, Jeollanam-do

  • Gachon University Gil Medical Center

    Incheon

  • Inha University Hospital

    Incheon

  • Jeonbuk national university hospital

    Jeonju, Jeollabuk-do

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, Gyeonggi-do

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Asan Medical Center

    Seoul

  • Kangbuk Samsung Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Kyung Hee University Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Severance Hospital, Yonsei University Health System

    Seoul

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

    Seoul

  • Ajou University Hospital

    Suwon, Gyeonggi-do

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

    Suwon, Gyeonggi-do

  • Ulsan University Hospital

    Ulsan

  • Pusan National University Yangsan Hospital

    Yangsan, Gyeongsangnam-do

Other trials in South Korea

Taiwan6 sites

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • Chi Mei Hospital, Liouying

    Tainan

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Memorial Hospital, Linkou

    Taoyuan

Other trials in Taiwan

About this study

Official title: 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).

Conditions
Gastric Cancer
Being tested
ONO-4578, Oxaliplatin, Capecitabine, S-1, Nivolumab
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ONO-4578Drug

    Specified dose, once daily

  • OxaliplatinDrug

    Specified dose on specified days

  • CapecitabineDrug

    Specified dose on specified days

  • S-1Drug

    Also called Tegafur-gimeracil-oteracil potassium

    Specified dose on specified days

  • NivolumabDrug

    Also called Opdivo

    Specified dose on specified days

  • PlaceboDrug

    Specified dose, once daily

Study groups in NCT06256328
Study groupRoleWhat they receive
ONO-4578+Nivolumab+chemotherapyExperimentalNot described
Receives: Drug: ONO-4578; Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab
placebo+Nivolumab+chemotherapyPlacebo comparatorNot described
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: S-1; Drug: Nivolumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free survival (PFS) (site investigator assessment)

    Measured: up to 2years

Secondary outcomes (9)

  1. Overall survival (OS)

    Measured: up to 2years

  2. Objective response rate (ORR) (site investigator assessment)

    Measured: up to 2years

  3. Best overall response (BOR) (site investigator assessment)

    Measured: up to 2years

  4. Duration of response (DOR) (site investigator assessment)

    Measured: up to 2years

  5. Disease control rate (DCR) (site investigator assessment)

    Measured: up to 2years

  6. Time to response (TTR) (site investigator assessment)

    Measured: up to 2years

  7. Maximum percent change in the sum diameters of the target lesions (site investigator assessment)

    Measured: up to 2years

  8. Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)

    Measured: up to 2years

  9. Adverse event (AE)

    Number of participants with treatment-emergent adverse events (TEAEs) as assessed by CTCAE v5.0

    Measured: Up to 30 days after the last dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2024
  2. Study start10 Jan 2024
  3. Primary completion9 Oct 2025
  4. Study completion31 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06256328
Sponsor's protocol ID
ONO-4578-08
Status last verified
Mar 2026
First submitted
23 Jan 2024
Last updated
13 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nakayama I, Ryu MH, Lim SH, Kim JG, Omori T, Oh SC, Kim JY, Rha SY, Lee KW, Machida N, Sym SJ, Narita Y, Park YI, Hara H, Hosaka H, Kang B, Kim IH, Bai LY, Hirashima Y, Hagihara S, Yamamoto T, Shitara K. EP4 Antagonist ONO-4578 Plus Nivolumab and Chemotherapy in Human Epidermal Growth Factor Receptor 2-Negative Unresectable Advanced or Recurrent Gastric or Gastroesophageal Junction Cancer. J Clin Oncol. 2026 Aug 10;44(23):2198-2210. doi: 10.1200/JCO-26-01072. Epub 2026 Jun 1.

    PubMed 42223130

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ONO-4578, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Ono Pharmaceutical Co., Ltd. at 63 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 63 sites in Japan, South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (site investigator assessment) (time frame: up to 2years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06256328, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.

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Clinical Trial NCT06256328 | AzTrials