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

NCT06421311 | Terminated FDA Drug

• 1 other identifier: CA209-1416
• Study Type: observational
• Target: 176
• Locations: 1 country
• Sites: 1

Brief Summary

This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease-free survival (DFS) of participants

  At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

Secondary Outcomes (32)

• Time to recurrence (TRR)

  At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60

• Distance metastases-free survival (DMFS)

  At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

• Non-urothelial tract recurrence free survival (NUTRFS)

  At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

• Locoregional disease free survival (LRFDS)

  At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

• Overall survival (OS)

  At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

Study Arms (1)

Participants with muscle invasive urothelial carcinoma receiving nivolumab

Drug: nivolumab

Interventions

nivolumab DRUG

According to approved product label (France)

Participants with muscle invasive urothelial carcinoma receiving nivolumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.

You may qualify if:

• Participants with pathological evidence of muscle invasive urothelial carcinoma (originating in bladder, ureter, or renal pelvis) at high risk of recurrence after radical resection with programmed death-ligand 1 (PD-L1) tumour cell expression ≥ 1%:
• 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)

You may not qualify if:

• Participants with a current primary diagnosis of a cancer other than muscle invasive urothelial carcinoma within the past 5 years, ie, a cancer other than urothelial carcinoma that requires systemic or other treatment or has not been treated curatively (as per discretion of the investigator)
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

Paris, 75002, France

Location

Related Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2024
• First Posted: May 20, 2024
• Study Start: July 30, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)