Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Ono Pharmaceutical Co., Ltd. | INDUSTRY |
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023 |
Not provided
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-specific inclusion/exclusion criteria apply.
Not provided
Not provided
Not provided
Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | City | State | Japan |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| 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 |