Clinical trial NCT06421311: Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
Official title: Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Urothelial Carcinoma
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-05-20
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Disease-free survival (DFS) of participants
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary outcomes:
measure: Time to recurrence (TRR)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Distance metastases-free survival (DMFS)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Non-urothelial tract recurrence free survival (NUTRFS)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Locoregional disease free survival (LRFDS)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Overall survival (OS)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Disease specific survival (DSS)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Second progression-free survival (PFS2)
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
measure: Participant demographics
timeFrame: Baseline
measure: Participant baseline clinical characteristics
timeFrame: Baseline
measure: Participant history of other cancer(s
timeFrame: Baseline
measure: Participant comorbidities pre-existing at the time of adjuvant therapy initiation
timeFrame: Index date
measure: Participant renal function at treatment initiation
timeFrame: Day 1
measure: Participant concomitant systemic treatment(s)
timeFrame: Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Diagnosis of muscle-invasive urothelial carcinoma diagnosis
timeFrame: Baseline
measure: Systemic neoadjuvant treatment history
timeFrame: Baseline
measure: Surgery for muscle-invasive urothelial carcinoma
timeFrame: Baseline
measure: Participant history of previous urothelial carcinoma
timeFrame: Baseline
measure: PD-L1 status testing results
timeFrame: Baseline
measure: Participant muscle Invasive urothelial carcinoma disease characteristics
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Time from initial diagnosis of muscle invasive disease to adjuvant treatment initiation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Delay in adjuvant nivolumab treatment initiation related to post-operative complications
timeFrame: Baseline
measure: Time from radical surgery to adjuvant nivolumab treatment initiation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Adjuvant nivolumab treatment duration
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Number of adjuvant nivolumab treatment cycles
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Dose adjuvant nivolumab per cycle
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Reason for adjuvant nivolumab treatment interruption
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Reason for adjuvant nivolumab treatment discontinuation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Non-systemic treatments prescribed post adjuvant nivolumab discontinuation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Systemic treatment prescribed post adjuvant nivolumab discontinuation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Participant adverse events
timeFrame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
measure: Participant reported outcomes as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire
timeFrame: Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36
Other outcomes:
Locations:
city: Paris
country: France
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: