Can a new drug boost immunotherapy against Hard-to-Treat stomach cancer?

NCT ID NCT07818070

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether adding an experimental drug called ONO-4578 to nivolumab and chemotherapy helps people with advanced or metastatic gastric cancer, esophagogastric junction cancer, or esophageal adenocarcinoma. The trial enrolls about 600 adults whose tumors are HER2-negative and PD-L1-positive and who have not yet received systemic treatment for advanced disease. Participants receive either ONO-4578 or a placebo alongside the same immunotherapy and chemotherapy, and researchers track how long they live and how long their cancer stays under control.

What this could mean

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

Active substance
an experimental drug called ONO-4578, given with nivolumab and chemotherapy
What this could lead to
If it works, adding ONO-4578 could give people with advanced stomach or esophageal cancer a better chance of living longer without their disease getting worse.
What could go wrong
This is a large phase 3 trial, but the drug is still experimental and may not improve survival over the current standard. Combining several treatments can also cause added side effects.

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

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Jan 2031

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

18 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.

Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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