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

An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Muscle-invasive Urothelial Carcinoma

• Study Type: Observational
• Enrollment (Estimated): 400

Contacts and Locations

Study Locations

• Japan
  • State
    • City, State, Japan
      • Local Institution

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort 1; Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 AEs		Up to 4 years
Number of participants with TRAEs		Up to 4 years
Overall survival (OS)	The time from the date of nivolumab initiation to the date of death from any cause	Up to 4 years
Disease-specific survival (DSS）	The time from the date of nivolumab initiation to the date of death due to the primary disease	Up to 4 years
Number of participants with immune-mediated adverse events (IMAEs) according to the Common Terminology Criteria for Adverse Events (CTCAEs) version 5.0		Up to 4 years
Number of participants with TRAEs leading to treatment discontinuation		Up to 4 years
Actual treatment status: treatment continuation rate	Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100	Up to 4 years
Actual treatment status: dosing intensity	Dose intensity (%)=(Actual dose)/(Total dose planned)×100	Up to 4 years
Post-recurrence treatment status: The number of participants transitioning to treatment	The proportion of eligible patients who completed and started treatment after recurrence.	Up to 4 years
The number of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence		Up to 4 years
The number of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence		Up to 4 years
The proportion of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence		Up to 4 years
The proportion of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence		Up to 4 years
The number of participants in each BOR category (CR/PR/stable disease (SD)/progressive disease (PD)/ not evaluated (NE)) receiving treatment after recurrence		Up to 4 years
The proportion of eligible participants with evaluable disease		Up to 4 years
Duration of treatment	The time from the start date of treatment administration to the last administration date after recurrence.	Up to 4 years
Time to treatment	The time from the start date of nivolumab to the start date of treatment after recurrence.	Up to 4 years
Estimated glomerular filtration rate (eGFR)	Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment	Up to 4 years
The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants		Up to 4 years
The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants		Up to 4 years
The clinical stage prior to NAC		Up to 4 years
The pathologic stage at the time of radical resection		Up to 4 years
Treatment completion rate (%)	(Participants who completed treatment)/(All eligible participants)x100	Up to 4 years

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Collaborators: Ono Pharmaceutical Co., Ltd.
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2022
• Primary Completion (Estimated): January 2, 2029
• Study Completion (Estimated): July 2, 2029

Study Registration Dates

• First Submitted: February 24, 2023
• First Submitted That Met QC Criteria: March 20, 2023
• First Posted (Actual): March 22, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Nivolumab; UTUC; UC
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell
• Other Study ID Numbers: CA209-6H7