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

Study Overview
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Brief Summary
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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.

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

Conditions
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Muscle-invasive Urothelial Carcinoma

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>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?
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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 |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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UC, Nivolumab, UTUC