An observational study in Muscle-invasive Urothelial Carcinoma, sponsored by Bristol-Myers Squibb. Active, not recruiting at 1 site in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-27.
Sponsored by Bristol-Myers Squibb · Observational
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.
Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.
Exclusion Criteria:
Other protocol-specific inclusion/exclusion criteria apply.
Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023
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.
Time frame: 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.
Time frame: Up to 4 years
Number of participants with adverse events (AEs)
Time frame: Up to 4 years
Number of participants with treatment-related adverse events (TRAEs)
Time frame: Up to 4 years
Actual treatment status: dosing frequency
Time frame: Up to 4 years
Actual treatment status: treatment duration
The time from the start date of nivolumab administration to the last administration date
Time frame: 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
Time frame: Up to 4 years
Actual treatment status: reason for discontinuation
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 years
Number of participants with AEs
Time frame: Up to 4 years
Number of participants with TRAEs
Time frame: Up to 4 years
Actual treatment status: dosing frequency
Time frame: Up to 4 years
Actual treatment status: treatment duration
The time from the start date of nivolumab administration to the last administration date
Time frame: 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
Time frame: Up to 4 years
Actual treatment status: reason for discontinuation
Time frame: Up to 4 years
Overall survival (OS)
The time from the date of nivolumab initiation to the date of death from any cause
Time frame: 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
Time frame: 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
Time frame: Up to 4 years
Number of participants with TRAEs leading to treatment discontinuation
Time frame: Up to 4 years
Actual treatment status: treatment continuation rate
Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100
Time frame: Up to 4 years
Actual treatment status: dosing intensity
Dose intensity (%)=(Actual dose)/(Total dose planned)×100
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 4 years
The proportion of eligible participants with evaluable disease
Time frame: Up to 4 years
Duration of treatment
The time from the start date of treatment administration to the last administration date after recurrence.
Time frame: Up to 4 years
Time to treatment
The time from the start date of nivolumab to the start date of treatment after recurrence.
Time frame: 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
Time frame: Up to 4 years
The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
Time frame: Up to 4 years
The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
Time frame: Up to 4 years
The clinical stage prior to NAC
Time frame: Up to 4 years
The pathologic stage at the time of radical resection
Time frame: Up to 4 years
Treatment completion rate (%)
(Participants who completed treatment)/(All eligible participants)x100
Time frame: Up to 4 years
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb