Clinical trial · Observational
A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma
An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan
NCT05779592CI-TRIAL-00112641ANNIVERSARYactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Muscle-invasive Urothelial Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Cohort 1
- description
- Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023
Primary outcomes (8)
- measure
- Disease-free survival (DFS)
- timeFrame
- Up to 4 years
- description
- 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.
- measure
- Non-urothelial tract recurrence free survival (NUTRFS)
- timeFrame
- Up to 4 years
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.