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Real-World check: does adding nivolumab to chemo help stomach cancer patients?

NCT ID NCT05334719

Knowledge-focused Sponsor: Bristol-Myers Squibb 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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study looked at how well a combination of nivolumab (an immunotherapy drug) and chemotherapy works for people with advanced or recurrent stomach cancer who haven't had treatment before. It involved 500 patients in Japan and tracked things like how long the cancer stayed under control and any side effects. The goal was to see how this treatment performs in everyday medical practice, not just in controlled experiments.

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.

Participants

500 people

The number who actually took part.

Started

Jun 2022

Finished

Jan 2026

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.

Who is studied

This study will include participants who received nivolumab plus chemotherapy as first-line treatment for unresectable advanced or recurrent gastric cancer at least once between nivolumab plus chemotherapy approval and December 31, 2022.

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: * Histologically confirmed advanced or recurrent gastric cancer * Have initiated or are confirmed to receive nivolumab plus chemotherapy as the first-line therapy between the date of approval of nivolumab plus chemotherapy and December 31, 2022. For combination chemotherapy, SOX, CapeOX, or FOLFOX is acceptable * Have signed a written informed consent form of their own free will after they have been given an adequate explanation and a full understanding of this study before enrolling in this study. Exclusion Criteria: * Treated with antineoplastic agents as first-line treatment for advanced or recurrent gastric cancer prior to the initiation of nivolumab plus chemotherapy (participants who have received prior perioperative chemotherapy and participants who have received prior bisphosphonates for osseous metastases may be enrolled) * Confirmed to be positive for HER2 * Diagnosed with gastric cancer and have previously received investigational drugs with anti-tumor effects * Initiated with nivolumab plus chemotherapy as the first-line treatment for advanced or recurrent gastric cancer at a site other than the study site and were later hospitalized at the study site. * Judged by the investigators to be inappropriate for enrollment in this study

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Conditions

The condition(s) this trial relates to.

gastric cancer gastric neoplasm Recurrence

As listed by the trial registrant

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

Stomach neoplasms

Contacts and locations

Locations

  • Local Institution - 0001

    Minato-ku, Tokyo, 1050001, Japan

More trials for these conditions

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