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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Urothelial Carcinoma
• Intervention / Treatment: Drug: nivolumab

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: BMS Study Connect Contact Center www.BMSStudyConnect.com; Phone Number: 855-907-3286; Email: Clinical.Trials@bms.com
• Study Contact Backup: Name: First line of the email MUST contain NCT # and Site #.

Study Locations

• France
  • Strasbourg, France, 67200
    • Icans Institut de Cancerologie Strasbourg Europe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with muscle invasive urothelial carcinoma receiving nivolumab	Drug: nivolumab; According to approved product label (France)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Disease-free survival (DFS) of participants	At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Disease specific survival (DSS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Second progression-free survival (PFS2)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Participant demographics		Baseline
Participant baseline clinical characteristics		Baseline
Participant history of other cancer(s		Baseline
Participant comorbidities pre-existing at the time of adjuvant therapy initiation		Index date
Participant renal function at treatment initiation		Day 1
Participant concomitant systemic treatment(s)		Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Diagnosis of muscle-invasive urothelial carcinoma diagnosis		Baseline
Systemic neoadjuvant treatment history		Baseline
Surgery for muscle-invasive urothelial carcinoma		Baseline
Participant history of previous urothelial carcinoma		Baseline
PD-L1 status testing results		Baseline
Participant muscle Invasive urothelial carcinoma disease characteristics		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Delay in adjuvant nivolumab treatment initiation related to post-operative complications		Baseline
Time from radical surgery to adjuvant nivolumab treatment initiation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Adjuvant nivolumab treatment duration		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Number of adjuvant nivolumab treatment cycles		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Dose adjuvant nivolumab per cycle		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment interruption		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Non-systemic treatments prescribed post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Systemic treatment prescribed post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant adverse events		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire	Prospective participants only	Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 20, 2024

Study Record Updates

• Last Update Posted (Actual): May 20, 2024
• Last Update Submitted That Met QC Criteria: May 17, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma; Carcinoma, Transitional Cell; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Nivolumab
• Other Study ID Numbers: CA209-1416

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No