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

Not Applicable

Recruiting

• Conditions: Muscle invasive urothelial carcinoma; MIUC; D002295

• Registration Number: JPRN-jRCT1031230091
• Lead Sponsor: AKANO TOMOYOSHI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-05-26
• Last Update Posted: 20 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 400

Inclusion Criteria

1) Patients aged 18 years or older
2) Patients with histologically definitive diagnosis of MIUC at each study site and who received nivolumab after radical resection
3) Patients who present at least once to the study site after nivolumab treatment or who have survival data
4) In the case of a patient who is currently visiting a study site participating in the study, the patient must be fully informed of their enrollment in the study and provide written consent of his/her own free will after sufficient understanding.

Exclusion Criteria

Patients who did not meet any of the following criteria at the time of obtaining consent will not be included in this study.
1) Patients who underwent only partial resection for MIUC
2) Patients treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or BCG therapy from the time of radical resection of MIUC to the start of nivolumab
3) Those who received investigational drugs after being diagnosed with MIUC and before or administered nivolumab
4) Patients previously treated with immune checkpoint inhibitors prior to nivolumab treatment
5) Patients judged to be inappropriate for enrollment in this study by the investigator at each participating study site

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness<br>- Disease-free survival (DFS)<br>- Non-urothelial tract recurrence free survival (NUTRFS)<br>Safety<br>- Incidence of all adverse events (AEs) and treatment-related adverse events (TRAEs)<br>Actual treatment status<br>- Treatment status of nivolumab (dosing frequency, treatment duration, treatment completion rate, and reason for discontinuation)

Secondary Outcome Measures

Name	Time	Method
To describe the outcomes of nivolumab as an adjuvant treatment for patients with muscle-invasive bladder cancer (MIBC) and those with upper tract urothelial carcinoma (UTUC) in a Japanese real-world clinical practice.<br>Effectiveness<br>- DFS<br>- NUTRFS<br>Safety<br>-Incidence of all AEs and TRAEs<br>Actual treatment status<br>- Treatment status of nivolumab (dosing frequency, treatment duration, treatment completion rate, and reason for discontinuation)