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..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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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

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.

Clinical Team contact

888-724-3274

clinicaltrials@deciphera.com

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

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.

Conditions: Gastric Cancer, Esophagogastric Junction Cancer, Esophageal Adenocarcinoma
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 CalciumDrug
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 groups in NCT07818070
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.

Feb 2027Jan 2031

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)

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

Interested in taking part?

Clinical Team

888-724-3274

clinicaltrials@deciphera.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)
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