Urothelial CarcinomaURADJNCT06421311
Observational Study of Muscle Invasive Urothelial Carcinoma Participants Treated With Adjuvant Nivolumab in France
An observational study of Urothelial Carcinoma, run by Bristol-Myers Squibb at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urothelial Carcinoma
- What is being tested?
- nivolumab
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2024to 4 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France
This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.
- Conditions
- Urothelial Carcinoma
- Being tested
- nivolumab
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabDrug
According to approved product label (France)
| Study group | Role | What they receive |
|---|---|---|
| Participants with muscle invasive urothelial carcinoma receiving nivolumab | Not described Receives: Drug: nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival (DFS) of participants
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Secondary outcomes (32)
Time to recurrence (TRR)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Distance metastases-free survival (DMFS)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Non-urothelial tract recurrence free survival (NUTRFS)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Locoregional disease free survival (LRFDS)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Overall survival (OS)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Disease specific survival (DSS)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Second progression-free survival (PFS2)
Measured: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Participant demographics
Measured: Baseline
Participant baseline clinical characteristics
Measured: Baseline
Participant history of other cancer(s
Measured: Baseline
Participant comorbidities pre-existing at the time of adjuvant therapy initiation
Measured: Index date
Participant renal function at treatment initiation
Measured: Day 1
Participant concomitant systemic treatment(s)
Measured: Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Diagnosis of muscle-invasive urothelial carcinoma diagnosis
Measured: Baseline
Systemic neoadjuvant treatment history
Measured: Baseline
Surgery for muscle-invasive urothelial carcinoma
Measured: Baseline
Participant history of previous urothelial carcinoma
Measured: Baseline
PD-L1 status testing results
Measured: Baseline
Participant muscle Invasive urothelial carcinoma disease characteristics
Measured: 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
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Delay in adjuvant nivolumab treatment initiation related to post-operative complications
Measured: Baseline
Time from radical surgery to adjuvant nivolumab treatment initiation
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Adjuvant nivolumab treatment duration
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Number of adjuvant nivolumab treatment cycles
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Dose adjuvant nivolumab per cycle
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment interruption
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment discontinuation
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Non-systemic treatments prescribed post adjuvant nivolumab discontinuation
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Systemic treatment prescribed post adjuvant nivolumab discontinuation
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation
Measured: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant adverse events
Measured: 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
Measured: Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start30 Jul 2024
- Primary completion4 Apr 2025
- Study completion4 Apr 2025
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urothelial CarcinomaStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421311
- Sponsor's protocol ID
- CA209-1416
- Acronym
- URADJ
- Status last verified
- Jun 2025
- First submitted
- 2 May 2024
- Last updated
- 5 Jun 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambispective Observational Study of Muscle Invasive Urothelial Carcinoma Patients Treated With Adjuvant Nivolumab in France
- ClinicalTrials.gov ID
- NCT06421311
- Acronym / sponsor ID
- URADJ / CA209-1416
- Conditions
- Urothelial Carcinoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 4 Apr 2025 (actual)
- Study completion
- 4 Apr 2025 (actual)
- First posted
- 20 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will estimate the real-world effectiveness of adjuvant nivolumab therapy in adult participants with muscle invasive urothelial carcinoma (MIUC) in France.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with muscle invasive urothelial carcinoma receiving nivolumab | – | Drug: nivolumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants in France with muscle invasive urothelial carcinoma (MIUC) that have been prescribed adjuvant nivolumab treatment.
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumabAccording to approved product label (France) | Drug | Participants with muscle invasive urothelial carcinoma receiving nivolumab |
Primary outcome
Disease-free survival (DFS) of participants
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
32 secondary outcomes
Time to recurrence (TRR)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Distance metastases-free survival (DMFS)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Non-urothelial tract recurrence free survival (NUTRFS)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Locoregional disease free survival (LRFDS)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Overall survival (OS)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Disease specific survival (DSS)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Second progression-free survival (PFS2)
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60
Participant demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Participant history of other cancer(s
Time frame: Baseline
Participant comorbidities pre-existing at the time of adjuvant therapy initiation
Time frame: Index date
Participant renal function at treatment initiation
Time frame: Day 1
Participant concomitant systemic treatment(s)
Time frame: Day 1 and at months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Diagnosis of muscle-invasive urothelial carcinoma diagnosis
Time frame: Baseline
Systemic neoadjuvant treatment history
Time frame: Baseline
Surgery for muscle-invasive urothelial carcinoma
Time frame: Baseline
Participant history of previous urothelial carcinoma
Time frame: Baseline
PD-L1 status testing results
Time frame: Baseline
Participant muscle Invasive urothelial carcinoma disease characteristics
Time frame: 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
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Delay in adjuvant nivolumab treatment initiation related to post-operative complications
Time frame: Baseline
Time from radical surgery to adjuvant nivolumab treatment initiation
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Adjuvant nivolumab treatment duration
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Number of adjuvant nivolumab treatment cycles
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Dose adjuvant nivolumab per cycle
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment interruption
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Reason for adjuvant nivolumab treatment discontinuation
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Non-systemic treatments prescribed post adjuvant nivolumab discontinuation
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Systemic treatment prescribed post adjuvant nivolumab discontinuation
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant response to prescribed systemic treatment post adjuvant nivolumab discontinuation
Time frame: At months 3, 6, 9, 12, 18, 24, 30, 36, 48 and 60
Participant adverse events
Time frame: 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
Time frame: Baseline, and at months 3, 6, 9, 12, 18, 24, 30, and 36
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2025.
- BMS Clinical Trial InformationLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urothelial Carcinoma, run by Bristol-Myers Squibb at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (DFS) of participants (time frame: At months 3, 6, 9, 12, 18, 24, 30, 26, 48 and 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2025.