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Muscle-invasive Urothelial CarcinomaANNIVERSARYNCT05779592

A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma

An observational study of Muscle-invasive Urothelial Carcinoma, run by Bristol-Myers Squibb at 1 site in Japan.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Muscle-invasive Urothelial Carcinoma
How many people
400 participants
Where
1 siteJapan
Study dates
23 Nov 2022to 2 Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

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: Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.

Who may be able to join

  • Must have a histologically definitive diagnosis of MIUC at each study site and who must have received nivolumab after radical resection
  • Must present at least once to the study site after nivolumab treatment or must have survival data

Who cannot join

  • Participants who underwent only partial resection for MIUC
  • Participants treated with chemotherapy, radiotherapy, biologics (anticancer agents), intravesical chemotherapy, or Bacillus Calmette-Guérin therapy from the time of radical resection of MIUC to the start of nivolumab
  • Participants previously treated with immune checkpoint inhibitors prior to nivolumab treatment
  • Other protocol-specific inclusion/exclusion criteria apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Local Institution

    City, State

Other trials in Japan

About this study

Official title: An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan

The purpose of this study is to evaluate the effectiveness, safety, and actual treatment status of nivolumab administered as an adjuvant treatment for participants with muscle-invasive urothelial carcinoma (MIUC), including bladder, renal pelvis, and ureteral cancer, in a Japanese real-world clinical practice.

Keywords
UC, Nivolumab, UTUC

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05779592
Study groupRoleWhat they receive
Cohort 1Muscle-invasive Urothelial Carcinoma Participants who received nivolumab as adjuvant treatment at least once from March 28, 2022 to December 31, 2023

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival (DFS)

    The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.

    Measured: Up to 4 years

  2. Non-urothelial tract recurrence free survival (NUTRFS)

    The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.

    Measured: Up to 4 years

  3. Number of participants with adverse events (AEs)

    Measured: Up to 4 years

  4. Number of participants with treatment-related adverse events (TRAEs)

    Measured: Up to 4 years

  5. Actual treatment status: dosing frequency

    Measured: Up to 4 years

  6. Actual treatment status: treatment duration

    The time from the start date of nivolumab administration to the last administration date

    Measured: Up to 4 years

  7. Actual treatment status: treatment completion rate

    The treatment completion rate will be calculated* according to the following formula:

    Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100

    Measured: Up to 4 years

  8. Actual treatment status: reason for discontinuation

    Measured: Up to 4 years

Secondary outcomes (29)

  1. DFS

    The time from the date of nivolumab initiation to the date of first recurrence (urothelial local recurrence, non-urothelial local recurrence, or distant recurrence) or death from any cause as an event, whichever occurs first.

    Measured: Up to 4 years

  2. NUTRFS

    The time from the date of nivolumab initiation to the date of first recurrence (local or distant non-urothelial recurrence) or death from any cause as an event, whichever occurs first.

    Measured: Up to 4 years

  3. Number of participants with AEs

    Measured: Up to 4 years

  4. Number of participants with TRAEs

    Measured: Up to 4 years

  5. Actual treatment status: dosing frequency

    Measured: Up to 4 years

  6. Actual treatment status: treatment duration

    The time from the start date of nivolumab administration to the last administration date

    Measured: Up to 4 years

  7. Actual treatment status: treatment completion rate

    The treatment completion rate will be calculated* according to the following formula:

    Treatment completion rate (%)=(Patients who completed treatment)/(All eligible patients)×100

    Measured: Up to 4 years

  8. Actual treatment status: reason for discontinuation

    Measured: Up to 4 years

  9. Overall survival (OS)

    The time from the date of nivolumab initiation to the date of death from any cause

    Measured: Up to 4 years

  10. Disease-specific survival (DSS）

    The time from the date of nivolumab initiation to the date of death due to the primary disease

    Measured: Up to 4 years

  11. Number of participants with immune-mediated adverse events (IMAEs) according to the Common Terminology Criteria for Adverse Events (CTCAEs) version 5.0

    Measured: Up to 4 years

  12. Number of participants with TRAEs leading to treatment discontinuation

    Measured: Up to 4 years

  13. Actual treatment status: treatment continuation rate

    Treatment continuation rate (%)=(Patients continuing treatment at the timepoint)/(All eligible patients)×100

    Measured: Up to 4 years

  14. Actual treatment status: dosing intensity

    Dose intensity (%)=(Actual dose)/(Total dose planned)×100

    Measured: Up to 4 years

  15. Post-recurrence treatment status: The number of participants transitioning to treatment

    The proportion of eligible patients who completed and started treatment after recurrence.

    Measured: Up to 4 years

  16. The number of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence

    Measured: Up to 4 years

  17. The number of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence

    Measured: Up to 4 years

  18. The proportion of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence

    Measured: Up to 4 years

  19. The proportion of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence

    Measured: Up to 4 years

  20. The number of participants in each BOR category (CR/PR/stable disease (SD)/progressive disease (PD)/ not evaluated (NE)) receiving treatment after recurrence

    Measured: Up to 4 years

  21. The proportion of eligible participants with evaluable disease

    Measured: Up to 4 years

  22. Duration of treatment

    The time from the start date of treatment administration to the last administration date after recurrence.

    Measured: Up to 4 years

  23. Time to treatment

    The time from the start date of nivolumab to the start date of treatment after recurrence.

    Measured: Up to 4 years

  24. Estimated glomerular filtration rate (eGFR)

    Measured before NAC, before radical resection, immediately before nivolumab treatment, at the time of recurrence, or at the start of post-recurrence treatment

    Measured: Up to 4 years

  25. The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants

    Measured: Up to 4 years

  26. The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants

    Measured: Up to 4 years

  27. The clinical stage prior to NAC

    Measured: Up to 4 years

  28. The pathologic stage at the time of radical resection

    Measured: Up to 4 years

  29. Treatment completion rate (%)

    (Participants who completed treatment)/(All eligible participants)x100

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2023
  2. Study start23 Nov 2022
  3. Primary completion2 Jan 2029 (estimated)
  4. Study completion2 Jul 2029 (estimated)

Resources

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
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05779592
Sponsor's protocol ID
CA209-6H7
Acronym
ANNIVERSARY
Status last verified
May 2026
First submitted
24 Feb 2023
Last updated
27 May 2026
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Muscle-invasive Urothelial Carcinoma, run by Bristol-Myers Squibb at 1 site in Japan.

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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 May 2026. 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 Japan. 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?

This study is still under way. Results are not available in the source record yet.

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) (time frame: Up to 4 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05779592.

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 27 May 2026.

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