Clinical trial NCT05779592: A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma
Official title: An Observational Study Evaluating Treatment Situations of Adjuvant Nivolumab for Muscle-invasive Urothelial Carcinoma in Japan
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Muscle-invasive Urothelial Carcinoma
Keywords: UC
Nivolumab
UTUC
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Ono Pharmaceutical Co. Ltd
First posted: 2023-03-22
Enrollment: 400
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: Participants who received adjuvant treatment with nivolumab for Muscle-invasive Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Disease-free survival (DFS)
timeFrame: Up to 4 years
measure: Non-urothelial tract recurrence free survival (NUTRFS)
timeFrame: Up to 4 years
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 4 years
measure: Number of participants with treatment-related adverse events (TRAEs)
timeFrame: Up to 4 years
measure: Actual treatment status: dosing frequency
timeFrame: Up to 4 years
measure: Actual treatment status: treatment duration
timeFrame: Up to 4 years
measure: Actual treatment status: treatment completion rate
timeFrame: Up to 4 years
measure: Actual treatment status: reason for discontinuation
timeFrame: Up to 4 years
Secondary outcomes:
measure: DFS
timeFrame: Up to 4 years
measure: NUTRFS
timeFrame: Up to 4 years
measure: Number of participants with AEs
timeFrame: Up to 4 years
measure: Number of participants with TRAEs
timeFrame: Up to 4 years
measure: Actual treatment status: dosing frequency
timeFrame: Up to 4 years
measure: Actual treatment status: treatment duration
timeFrame: Up to 4 years
measure: Actual treatment status: treatment completion rate
timeFrame: Up to 4 years
measure: Actual treatment status: reason for discontinuation
timeFrame: Up to 4 years
measure: Overall survival (OS)
timeFrame: Up to 4 years
measure: Disease-specific survival (DSS）
timeFrame: Up to 4 years
measure: Number of participants with immune-mediated adverse events (IMAEs) according to the Common Terminology Criteria for Adverse Events (CTCAEs) version 5.0
timeFrame: Up to 4 years
measure: Number of participants with TRAEs leading to treatment discontinuation
timeFrame: Up to 4 years
measure: Actual treatment status: treatment continuation rate
timeFrame: Up to 4 years
measure: Actual treatment status: dosing intensity
timeFrame: Up to 4 years
measure: Post-recurrence treatment status: The number of participants transitioning to treatment
timeFrame: Up to 4 years
measure: The number of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence
timeFrame: Up to 4 years
measure: The number of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence
timeFrame: Up to 4 years
measure: The proportion of participants with complete response (CR) due to treatment relative to those with evaluable disease who were treated after recurrence
timeFrame: Up to 4 years
measure: The proportion of participants with partial response (PR) due to treatment relative to those with evaluable disease who were treated after recurrence
timeFrame: Up to 4 years
measure: The number of participants in each BOR category (CR/PR/stable disease (SD)/progressive disease (PD)/ not evaluated (NE)) receiving treatment after recurrence
timeFrame: Up to 4 years
measure: The proportion of eligible participants with evaluable disease
timeFrame: Up to 4 years
measure: Duration of treatment
timeFrame: Up to 4 years
measure: Time to treatment
timeFrame: Up to 4 years
measure: Estimated glomerular filtration rate (eGFR)
timeFrame: Up to 4 years
measure: The regimen of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
timeFrame: Up to 4 years
measure: The number of cycles of Neoadjuvant chemotherapy (NAC) performed prior to radical resection in eligible participants
timeFrame: Up to 4 years
measure: The clinical stage prior to NAC
timeFrame: Up to 4 years
measure: The pathologic stage at the time of radical resection
timeFrame: Up to 4 years
measure: Treatment completion rate (%)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: City
country: Japan
facility: Local Institution
state: State
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: