A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma
- Conditions
- Muscle-invasive Urothelial Carcinoma
- Registration Number
- NCT05779592
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of participants with treatment-related adverse events (TRAEs) Up to 4 years Actual treatment status: reason for discontinuation Up to 4 years Disease-free survival (DFS) Up to 4 years 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.
Actual treatment status: dosing frequency Up to 4 years Non-urothelial tract recurrence free survival (NUTRFS) Up to 4 years 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.
Number of participants with adverse events (AEs) Up to 4 years Actual treatment status: treatment duration Up to 4 years The time from the start date of nivolumab administration to the last administration date
Actual treatment status: treatment completion rate Up to 4 years The treatment completion rate will be calculated\* according to the following formula:
Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100
- Secondary Outcome Measures
Name Time Method DFS Up to 4 years 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.
Number of participants with AEs Up to 4 years Treatment completion rate (%) Up to 4 years (Participants who completed treatment)/(All eligible participants)x100
Number of participants with TRAEs Up to 4 years Overall survival (OS) Up to 4 years The time from the date of nivolumab initiation to the date of death from any cause
The clinical stage prior to NAC Up to 4 years The pathologic stage at the time of radical resection Up to 4 years Actual treatment status: reason for discontinuation 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 Time to treatment Up to 4 years The time from the start date of nivolumab to the start date of treatment after recurrence.
Estimated glomerular filtration rate (eGFR) Up to 4 years Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment
The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants Up to 4 years NUTRFS Up to 4 years 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.
Actual treatment status: dosing frequency Up to 4 years Actual treatment status: treatment duration Up to 4 years The time from the start date of nivolumab administration to the last administration date
Actual treatment status: treatment completion rate Up to 4 years The treatment completion rate will be calculated\* according to the following formula:
Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100Number 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 Actual treatment status: treatment continuation rate Up to 4 years Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100
Actual treatment status: dosing intensity Up to 4 years Dose intensity (%)=(Actual dose)/(Total dose planned)×100
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 eligible participants with evaluable disease Up to 4 years Number of participants with TRAEs leading to treatment discontinuation 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 Duration of treatment Up to 4 years The time from the start date of treatment administration to the last administration date after recurrence.
Disease-specific survival (DSS） Up to 4 years The time from the date of nivolumab initiation to the date of death due to the primary disease
Post-recurrence treatment status: The number of participants transitioning to treatment Up to 4 years The proportion of eligible patients who completed and started treatment after recurrence.
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 number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants Up to 4 years
Trial Locations
- Locations (1)
Local Institution
🇯🇵City, State, Japan