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NCT Number: NCT05779592

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Muscle-invasive Urothelial Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

City, State, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Disease-free survival (DFS)

    Time frame: Up to 4 years

    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.

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

    Time frame: Up to 4 years

    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.

  3. Number of participants with adverse events (AEs)

    Time frame: Up to 4 years

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

    Time frame: Up to 4 years

  5. Actual treatment status: dosing frequency

    Time frame: Up to 4 years

  6. Actual treatment status: treatment duration

    Time frame: Up to 4 years

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

  7. Actual treatment status: treatment completion rate

    Time frame: Up to 4 years

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

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

  8. Actual treatment status: reason for discontinuation

    Time frame: Up to 4 years

Secondary outcomes

  1. DFS

    Time frame: Up to 4 years

    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.

  2. NUTRFS

    Time frame: Up to 4 years

    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.

  3. Number of participants with AEs

    Time frame: Up to 4 years

  4. Number of participants with TRAEs

    Time frame: Up to 4 years

  5. Actual treatment status: dosing frequency

    Time frame: Up to 4 years

  6. Actual treatment status: treatment duration

    Time frame: Up to 4 years

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

  7. Actual treatment status: treatment completion rate

    Time frame: Up to 4 years

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

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

  8. Actual treatment status: reason for discontinuation

    Time frame: Up to 4 years

  9. Overall survival (OS)

    Time frame: Up to 4 years

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

  10. Disease-specific survival (DSS）

    Time frame: Up to 4 years

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

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

    Time frame: Up to 4 years

  12. Number of participants with TRAEs leading to treatment discontinuation

    Time frame: Up to 4 years

  13. Actual treatment status: treatment continuation rate

    Time frame: Up to 4 years

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

  14. Actual treatment status: dosing intensity

    Time frame: Up to 4 years

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

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

    Time frame: Up to 4 years

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

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 4 years

  21. The proportion of eligible participants with evaluable disease

    Time frame: Up to 4 years

  22. Duration of treatment

    Time frame: Up to 4 years

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

  23. Time to treatment

    Time frame: Up to 4 years

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

  24. Estimated glomerular filtration rate (eGFR)

    Time frame: Up to 4 years

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

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

    Time frame: Up to 4 years

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

    Time frame: Up to 4 years

  27. The clinical stage prior to NAC

    Time frame: Up to 4 years

  28. The pathologic stage at the time of radical resection

    Time frame: Up to 4 years

  29. Treatment completion rate (%)

    Time frame: Up to 4 years

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Acronym: ANNIVERSARY

Important dates

Study start
2022
Primary completion
2029
Study completion
2029
First posted
Mar 22, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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