Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
- Registration Number
- NCT06421311
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Participants with muscle invasive urothelial carcinoma receiving nivolumab nivolumab -
- Primary Outcome Measures
Name Time Method Disease-free survival (DFS) of participants At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
- Secondary Outcome Measures
Name Time Method Dose adjuvant nivolumab per cycle 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 Distance metastases-free survival (DMFS) At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 Time to recurrence (TRR) At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Non-urothelial tract recurrence free survival (NUTRFS) At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 Participant comorbidities pre-existing at the time of adjuvant therapy initiation Index date Participant renal function at treatment initiation Day 1 Number of adjuvant nivolumab treatment cycles 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 Overall survival (OS) At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 Participant baseline clinical characteristics Baseline Participant concomitant systemic treatment(s) Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 Participant muscle Invasive urothelial carcinoma disease characteristics 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 Locoregional disease free survival (LRFDS) 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 Systemic neoadjuvant treatment history Baseline Participant history of previous urothelial carcinoma Baseline PD-L1 status testing results Baseline Time from radical surgery to adjuvant nivolumab treatment initiation 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 Disease specific survival (DSS) At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 Surgery for muscle-invasive urothelial carcinoma Baseline Delay in adjuvant nivolumab treatment initiation related to post-operative complications Baseline Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation 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 Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36 Prospective participants only
Participant history of other cancer(s Baseline Diagnosis of muscle-invasive urothelial carcinoma diagnosis Baseline 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 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
Trial Locations
- Locations (2)
Local Institution - 0001
🇫🇷Paris, France
ICANS Institut de Cancérologie Strasbourg Europe
🇫🇷Strasbourg, France