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

Urothelial Carcinoma Clinical Trial

— URADJ  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06421311
• Other study ID #: CA209-1416
• Status: Not yet recruiting
• Start date: June 15, 2024
• Est. completion date: May 1, 2028

Study information

• Verified date: May 2024
• Source: Bristol-Myers Squibb
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 1, 2028
• Est. primary completion date: May 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• nivolumab
According to approved product label (France)

Locations

Country	Name	City	State
France	ICANS Institut de Cancérologie Strasbourg Europe	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease-free survival (DFS) of participants		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Time to recurrence (TRR)		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Distance metastases-free survival (DMFS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Non-urothelial tract recurrence free survival (NUTRFS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Locoregional disease free survival (LRFDS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Overall survival (OS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Disease specific survival (DSS)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Second progression-free survival (PFS2)		At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary	Participant demographics		Baseline
Secondary	Participant baseline clinical characteristics		Baseline
Secondary	Participant history of other cancer(s		Baseline
Secondary	Participant comorbidities pre-existing at the time of adjuvant therapy initiation		Index date
Secondary	Participant renal function at treatment initiation		Day 1
Secondary	Participant concomitant systemic treatment(s)		Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Diagnosis of muscle-invasive urothelial carcinoma diagnosis		Baseline
Secondary	Systemic neoadjuvant treatment history		Baseline
Secondary	Surgery for muscle-invasive urothelial carcinoma		Baseline
Secondary	Participant history of previous urothelial carcinoma		Baseline
Secondary	PD-L1 status testing results		Baseline
Secondary	Participant muscle Invasive urothelial carcinoma disease characteristics		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	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
Secondary	Delay in adjuvant nivolumab treatment initiation related to post-operative complications		Baseline
Secondary	Time from radical surgery to adjuvant nivolumab treatment initiation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Adjuvant nivolumab treatment duration		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Number of adjuvant nivolumab treatment cycles		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Dose adjuvant nivolumab per cycle		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Reason for adjuvant nivolumab treatment interruption		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Reason for adjuvant nivolumab treatment discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Non-systemic treatments prescribed post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Systemic treatment prescribed post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	Participant adverse events		At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Secondary	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

External Links

•   BMS Clinical Trial Information
•   FDA Safety Alerts and Recalls