Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
NCT ID: NCT06421311
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
176 participants
OBSERVATIONAL
2024-07-30
2025-04-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Participants with muscle invasive urothelial carcinoma receiving nivolumab
nivolumab
According to approved product label (France)
Interventions
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nivolumab
According to approved product label (France)
Eligibility Criteria
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Inclusion Criteria
* Who received neoadjuvant chemotherapy OR
* Who did not receive neoadjuvant chemotherapy and who are not eligible or refusing adjuvant cisplatin chemotherapy
* At least 18 years of age at the time of treatment decision
* Decision to treat with adjuvant nivolumab therapy has already been taken
* Participants who provide oral informed consent to participate in the study (or who express non-opposition to data collection during their lifetime for deceased patients enrolled retrospectively)
Exclusion Criteria
* Participants currently enrolled in an interventional clinical trial for their urothelial carcinoma. Patients who have completed their participation in an interventional trial or who are not receiving study drug anymore and who are only followed-up for overall survival (OS) can be enrolled. Patients enrolled in a clinical trial not evaluating an investigational drug can be enrolled (e.g. trial investigating novel imaging modalities).
* Pregnant women
* Participants under guardianship
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0001
Paris, , France
Countries
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Related Links
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BMS Clinical Trial Information
FDA Safety Alerts and Recalls
Other Identifiers
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CA209-1416
Identifier Type: -
Identifier Source: org_study_id
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