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

NCT05779592 | Active Not Recruiting

• 1 other identifier: CA209-6H7
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Muscle-invasive Urothelial Carcinoma

Keywords

UC; Nivolumab; UTUC

Outcome Measures

Primary Outcomes (8)

• Disease-free survival (DFS)

  The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.

  Up to 4 years

• Non-urothelial tract recurrence free survival (NUTRFS)

  The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.

  Up to 4 years

• Number of participants with adverse events (AEs)

  Up to 4 years

• Number of participants with treatment-related adverse events (TRAEs)

  Up to 4 years

• Actual treatment status: dosing frequency

  Up to 4 years

• Actual treatment status: treatment duration

  The time from the start date of nivolumab administration to the last administration date

  Up to 4 years

• Actual treatment status: treatment completion rate

  The treatment completion rate will be calculated\* according to the following formula: Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100

  Up to 4 years

• Actual treatment status: reason for discontinuation

  Up to 4 years

Secondary Outcomes (29)

• DFS

  Up to 4 years

• NUTRFS

  Up to 4 years

• Number of participants with AEs

  Up to 4 years

• Number of participants with TRAEs

  Up to 4 years

• Actual treatment status: dosing frequency

  Up to 4 years

Study Arms (1)

Cohort 1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead
• Ono Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Local Institution

City, State, Japan

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 22, 2023
• Study Start: November 23, 2022
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: June 27, 2025

Record last verified: 2025-06

Locations

JP (1)