Not provided
Not provided
Not provided
Not provided
Not provided
Business objectives have changed
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with muscle invasive urothelial carcinoma receiving nivolumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nivolumab | Drug | According to approved product label (France) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival (DFS) of participants | At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 |
| 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 | |
Not provided
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%:
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:
Not provided
Not provided
Not provided
Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Paris | 75002 | France |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |