An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Muscle-invasive Urothelial Carcinoma
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Number of participants with treatment-related adverse events (TRAEs)
- Status
- Active, not recruiting
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Number of participants with treatment-related adverse events (TRAEs)
Time Frame: Up to 4 years
Actual treatment status: reason for discontinuation
Time Frame: Up to 4 years
Disease-free survival (DFS)
Time Frame: 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
Time Frame: Up to 4 years
Non-urothelial tract recurrence free survival (NUTRFS)
Time Frame: 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)
Time Frame: Up to 4 years
Actual treatment status: treatment duration
Time Frame: Up to 4 years
The time from the start date of nivolumab administration to the last administration date
Actual treatment status: treatment completion rate
Time Frame: 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 Outcomes
- DFS(Up to 4 years)
- Number of participants with AEs(Up to 4 years)
- Treatment completion rate (%)(Up to 4 years)
- Number of participants with TRAEs(Up to 4 years)
- Overall survival (OS)(Up to 4 years)
- The proportion of eligible participants with evaluable disease(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)
- 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)
- Estimated glomerular filtration rate (eGFR)(Up to 4 years)
- The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants(Up to 4 years)
- NUTRFS(Up to 4 years)
- Actual treatment status: dosing frequency(Up to 4 years)
- Actual treatment status: treatment duration(Up to 4 years)
- Actual treatment status: treatment completion rate(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)
- Actual treatment status: treatment continuation rate(Up to 4 years)
- Actual treatment status: dosing intensity(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)
- 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)
- Disease-specific survival (DSS）(Up to 4 years)
- Post-recurrence treatment status: The number of participants transitioning to treatment(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 number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants(Up to 4 years)