Gastric CancerPhase 3NCT07818070
A Trial of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
A Phase 3 study testing ONO-4578, Nivolumab and Oxaliplatin in people with Gastric Cancer and Esophagogastric Junction Cancer, run by Ono Pharmaceutical Co., Ltd..
Trial summary
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Esophagogastric Junction Cancer, Esophageal Adenocarcinoma
- What is being tested?
- ONO-4578, Nivolumab and Oxaliplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Feb 2027to Jan 2031
- Phase
- Phase 3
- 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
- Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma.
- Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
- Participants who have received neoadjuvant or adjuvant therapy may be included if no residual tumors are found after surgery (R0 resection) and if the therapy was completed at least 180 days before the date of recurrence.
- Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1).
- Tumor programmed cell death ligand 1 (PD-L1) expression must be confirmed as combined positive score (CPS ≥1) prior to randomization.
- Participant must be able to provide tissues samples for analyses.
Who cannot join
- Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization.
- Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status.
- Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization.
- Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids.
- Participants with vitiligo, type 1 diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled.
- Other protocol-defined inclusion and exclusion criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
Participants will:
- Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy.
- Make visits to the clinic for checkups and tests.
- Answer questions about their health throughout the trial.
- Being tested
- ONO-4578, Placebo, Nivolumab, Oxaliplatin, Capecitabine
- Keywords
- ONO-4578, Programmed cell death ligand 1 positive, Human epidermal growth factor 2 negative, Nivolumab, HER2-negative, PD-L1-positive, Advanced Gastroesophageal Junction (GEJ), Adenocarcinoma, Advanced Gastric Adenocarcinoma, Advanced Esophageal Adenocarcinoma, Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction (GEJ), Metastatic Esophageal Adenocarcinoma
- Medical subject headings
- Stomach Neoplasms, Adenocarcinoma Of Esophagus, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONO-4578Drug
ONO-4578 will be administered to participants at a specified dose once daily.
PlaceboOther
Matching placebo for ONO-4578 will be administered to participants once daily.
NivolumabDrug
Nivolumab will be administered to participants at a specified dose on specified days.
OxaliplatinDrug
Oxaliplatin will be administered to participants at a specified dose on specified days.
CapecitabineDrug
Capecitabine will be administered to participants at a specified dose on specified days.
Tegafur-gimeracil-oteracil potassium (S-1)Drug
S-1 will be administered to participants at a specified dose on specified days.
FluorouracilDrug
Fluorouracil will be administered to participants at a specified dose on specified days.
Leucovorin Calcium will be administered to participants at a specified dose on specified days.
LevoleucovorinDrug
Levoleucovorin will be administered to participants at a specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| ONO-4578 + Nivolumab + Chemotherapy | Experimental | Participants will receive nivolumab and chemotherapy, which will include some of the listed agents. Receives: Drug: ONO-4578; Drug: Nivolumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tegafur-gimeracil-oteracil potassium (S-1); Drug: Fluorouracil; Drug: Leucovorin Calcium; Drug: Levoleucovorin |
| Placebo + Nivolumab + Chemotherapy | Active comparator | Participants will receive placebo and chemotherapy, which will include some of the listed agents. Receives: Other: Placebo; Drug: Nivolumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Tegafur-gimeracil-oteracil potassium (S-1); Drug: Fluorouracil; Drug: Leucovorin Calcium; Drug: Levoleucovorin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Measured: Up to approximately 4 years
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Measured: Up to approximately 4 years
Secondary outcomes (6)
PFS per Investigator Assessment
Measured: Up to approximately 4 years
Objective Response Rate (ORR) per BICR
Measured: Up to approximately 4 years
Duration of Response (DOR) per BICR
Measured: Up to approximately 4 years
Disease Control Rate (DCR) per BICR
Measured: Up to approximately 4 years
Time to Response (TTR) per BICR
Measured: Up to approximately 4 years
PFS After the Next-line of Therapy (PFS2) per Investigator Assessment
Measured: Up to approximately 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startFeb 2027 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Ono Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals, LLC
- Responsible party
- Sponsor
- Investigators
- Clinical Team, Study director, Ono Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818070
- Sponsor's protocol ID
- ONO-4578-03-001
- Other IDs
- 2026-526792-27-00
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Multicenter, Double-blind Study of the Efficacy and Safety of ONO-4578 Versus Placebo in Combination With Nivolumab and Chemotherapy in Participants With HER2-negative, PD-L1-Positive Advanced or Metastatic Gastric Cancer, Esophagogastric Junction Cancer, or Esophageal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07818070
- Acronym / sponsor ID
- ONO-4578-03-001
- Keywords
- ONO-4578, Programmed cell death ligand 1 positive, Human epidermal growth factor 2 negative, Nivolumab, HER2-negative, PD-L1-positive, Advanced Gastroesophageal Junction (GEJ), Adenocarcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ono Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Deciphera Pharmaceuticals, LLC
- Study start
- Feb 2027 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of ONO-4578 in combination nivolumab and chemotherapy in participants with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
Participants will:
- Receive either ONO-4578 with nivolumab and chemotherapy or placebo with nivolumab and chemotherapy.
- Make visits to the clinic for checkups and tests.
- Answer questions about their health throughout the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ONO-4578 + Nivolumab + Chemotherapy | Experimental | Drug: ONO-4578, Drug: Nivolumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Tegafur-gimeracil-oteracil potassium (S-1), Drug: Fluorouracil, Drug: Leucovorin Calcium, Drug: LevoleucovorinParticipants will receive nivolumab and chemotherapy, which will include some of the listed agents. |
| Placebo + Nivolumab + Chemotherapy | Active comparator | Other: Placebo, Drug: Nivolumab, Drug: Oxaliplatin, Drug: Capecitabine, Drug: Tegafur-gimeracil-oteracil potassium (S-1), Drug: Fluorouracil, Drug: Leucovorin Calcium, Drug: LevoleucovorinParticipants will receive placebo and chemotherapy, which will include some of the listed agents. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Have advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma that has been histologically confirmed to be predominant adenocarcinoma.
- Have not been treated with systemic anticancer agents for advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma.
- Have measurable or nonmeasurable disease, as defined in Response Evaluation Criteria in Solid Tumors (RECIST) Guideline v1.1, and documented on computed tomography (CT) or magnetic resonance imaging (MRI) images within 42 days before Cycle 1 Day 1 (C1D1).
- Tumor programmed cell death ligand 1 (PD-L1) expression must be confirmed as combined positive score (CPS ≥1) prior to randomization.
- Participant must be able to provide tissues samples for analyses.
Key exclusion criteria (6 listed)
- Participants with Human epidermal growth factor 2 (HER2)-positive or indeterminate gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma as determined by local testing. Determination for HER2 positivity is made based on the reference in each site. If there is no reference, rough indication for positive is 3+ by immunohistochemistry (IHC), or 2+ by IHC and positive by in situ hybridization.
- Participants whose tumors have known microsatellite instability-high or mismatch repair-deficient status.
- Marked malnutrition requiring continuous enteral nutrition or intravenous hyperalimentation, or continuous infusion therapy with hospitalization.
- Active autoimmune disease, or history of autoimmune disease that might recur, that may affect vital organ function, or that may require immune-suppressive treatment, including systemic corticosteroids.
- Other protocol-defined inclusion and exclusion criteria apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONO-4578ONO-4578 will be administered to participants at a specified dose once daily. | Drug | ONO-4578 + Nivolumab + Chemotherapy |
| PlaceboMatching placebo for ONO-4578 will be administered to participants once daily. | Other | Placebo + Nivolumab + Chemotherapy |
| NivolumabNivolumab will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| OxaliplatinOxaliplatin will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| CapecitabineCapecitabine will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| Tegafur-gimeracil-oteracil potassium (S-1)S-1 will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| FluorouracilFluorouracil will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| Leucovorin CalciumLeucovorin Calcium will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
| LevoleucovorinLevoleucovorin will be administered to participants at a specified dose on specified days. | Drug | ONO-4578 + Nivolumab + Chemotherapy, Placebo + Nivolumab + Chemotherapy |
Primary outcome
Overall Survival (OS)
Time frame: Up to approximately 4 years
Progression-Free Survival (PFS) per Blinded Independent Central Review (BICR)
Time frame: Up to approximately 4 years
6 secondary outcomes
PFS per Investigator Assessment
Time frame: Up to approximately 4 years
Objective Response Rate (ORR) per BICR
Time frame: Up to approximately 4 years
Duration of Response (DOR) per BICR
Time frame: Up to approximately 4 years
Disease Control Rate (DCR) per BICR
Time frame: Up to approximately 4 years
Time to Response (TTR) per BICR
Time frame: Up to approximately 4 years
PFS After the Next-line of Therapy (PFS2) per Investigator Assessment
Time frame: Up to approximately 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Team study director
Ono Pharmaceutical Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ONO-4578, Nivolumab and Oxaliplatin in people with Gastric Cancer and Esophagogastric Junction Cancer, run by Ono Pharmaceutical Co., Ltd..
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 6 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Clinical Team (888-724-3274, clinicaltrials@deciphera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: Up to approximately 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2026.