A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma

NCT ID: NCT05779592

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-23

Study Completion Date

2027-09-30

Brief Summary

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The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.

Detailed Description

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Conditions

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Muscle-invasive Urothelial Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Cohort 1

Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ono Pharmaceutical Co. Ltd

INDUSTRY

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

City, State, Japan

Site Status

Countries

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Japan

Related Links

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Other Identifiers

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CA209-6H7

Identifier Type: -

Identifier Source: org_study_id

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