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

Bristol-Myers Squibb (BMS)

Status: Active, not recruiting

Conditions: Muscle-invasive Urothelial Carcinoma

Study type: Observational

Funder types: Industry

Identifiers

NCT05779592

CA209-6H7

Details and patient eligibility

About

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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

Cohort 1

Description:

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