Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France

Recruiting

• Conditions: Urothelial Carcinoma

• Registration Number: NCT06421311
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-5-2
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Inclusion Criteria:<br><br> - Participants with pathological evidence of muscle invasive urothelial carcinoma<br> (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after<br> radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression =<br> 1%:<br><br> - Who received neoadjuvant chemotherapy OR<br><br> - Who did not receive neoadjuvant chemotherapy and who are not eligible or<br> refusing adjuvant cisplatin chemotherapy<br><br> - At least 18 years of age at the time of treatment decision<br><br> - Decision to treat with adjuvant nivolumab therapy has already been taken<br><br> - Participants who provide oral informed consent to participate in the study (or who<br> express non-opposition to data collection during their lifetime for deceased<br> patients enrolled retrospectively)<br><br>Exclusion Criteria:<br><br> - Participants with a current primary diagnosis of a cancer other than muscle invasive<br> urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial<br> carcinoma that requires systemic or other treatment or has not been treated<br> curatively (as per discretion of the investigator)<br><br> - Participants currently enrolled in an interventional clinical trial for their<br> urothelial carcinoma. Patients who have completed their participation in an<br> interventional trial or who are not receiving study drug anymore and who are only<br> followed-up for overall survival (OS) can be enrolled. Patients enrolled in a<br> clinical trial not evaluating an investigational drug can be enrolled (e.g. trial<br> investigating novel imaging modalities).<br><br> - Pregnant women<br><br> - Participants under guardianship

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) of participants