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Real-World data sought on nivolumab for bladder cancer after surgery

NCT ID NCT05779592

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observes 400 Japanese patients with muscle-invasive urothelial carcinoma who received nivolumab after surgery to remove their cancer. Researchers will track how long patients stay cancer-free, side effects, and how the drug is actually used in clinics. The goal is to see if nivolumab's benefits seen in clinical trials hold up in everyday practice.

What this could mean

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

Active substance
nivolumab
What this could lead to
If successful, this study could confirm that nivolumab is effective and safe in everyday clinical settings for preventing cancer recurrence after surgery.
What could go wrong
This is an observational study, not a controlled trial, so results may be less definitive. It only includes Japanese patients, so findings may not apply to other populations.

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

About 400 people

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

Started

Nov 2022

Expected to finish

Jul 2029

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.

Who is studied

Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.

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.

Inclusion Criteria: * Must have a histologically definitive diagnosis of MIUC at each study site and who must have received nivolumab after radical resection * Must present at least once to the study site after nivolumab treatment or must have survival data Exclusion Criteria: * Participants who underwent only partial resection for MIUC * Participants treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or Bacillus Calmette-Guérin therapy from the time of radical resection of MIUC to the start of nivolumab * Participants previously treated with immune checkpoint inhibitors prior to nivolumab treatment Other protocol-specific inclusion/exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma infiltrating urothelial carcinoma

As listed by the trial registrant

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

Muscle-invasive urothelial carcinoma

Contacts and locations

Locations

  • Local Institution

    City, State, Japan

More trials for these conditions

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