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Trial Title:
A Study to Evaluate Nivolumab in Japanese Participants With Muscle-invasive Urothelial Carcinoma
NCT ID:
NCT05779592
Condition:
Muscle-invasive Urothelial Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Transitional Cell
Conditions: Keywords:
UC
Nivolumab
UTUC
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Other
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.
Criteria for eligibility:
Study pop:
Participants who received adjuvant treatment with nivolumab for Muscle-invasive
Urothelial Carcinoma (MIUC) at least once from March 28, 2022 to December 31, 2023.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution
Address:
City:
City
Country:
Japan
Start date:
July 1, 2023
Completion date:
February 28, 2027
Lead sponsor:
Agency:
Bristol-Myers Squibb
Agency class:
Industry
Collaborator:
Agency:
Ono Pharmaceutical Co. Ltd
Agency class:
Industry
Source:
Bristol-Myers Squibb
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779592
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
