Urothelial Carcinoma
Conditions
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.
Interventions
DRUGnivolumab
According to approved product label (France)
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease-free survival (DFS) of participants | At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation | At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 | — |
| 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 | — |
| Participant adverse events | At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60 | — |
| 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 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 |
| Systemic neoadjuvant treatment history | Baseline | — |
Countries
France
Outcome results
None listed