UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062258 |
|---|---|
| Receipt number | R000068882 |
| Scientific Title | Initial Real-World Experience of Enfortumab Vedotin Combined with Pembrolizumab for Unresectable Urothelial Carcinoma in Shinshu University-Affiliated Centers |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/16 19:56:17 |
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Basic information
Public title
Initial Real-World Experience of Enfortumab Vedotin Combined with Pembrolizumab for Unresectable Urothelial Carcinoma in Shinshu University-Affiliated Centers
Acronym
SHINSHU study
Scientific Title
Initial Real-World Experience of Enfortumab Vedotin Combined with Pembrolizumab for Unresectable Urothelial Carcinoma in Shinshu University-Affiliated Centers
Scientific Title:Acronym
SHINSHU study
Region
| Japan |
Condition
Condition
metastatic/unresectable Urothelial carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Following the EV-302 trial, which demonstrated the efficacy of combination therapy with Enfortumab Vedotin and Pembrolizumab (EV+P), this regimen has been established as the current standard first-line treatment for mUC. In this study, we report the multicenter, real-world therapeutic efficacy and safety of the first-line EV+P therapy, along with a review of the literature.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall response rate, Overall survival
Key secondary outcomes
Adverse event, Subgroup analysis
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All patients diagnosed with urothelial carcinoma based on pathological examination (including biopsy and transurethral surgery) who were deemed unsuitable for curative resection based on imaging studies and clinical judgment and subsequently treated with EV+PEM.
Key exclusion criteria
1. Histological subtypes other than urothelial carcinoma.
2. Cases in which the patient or their family declined consent for data disclosure.
3. Any other cases deemed inappropriate for inclusion by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Shiozaki |
Organization
Shinshu University School of Medicine
Division name
Department of Urology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2661
m-shiozaki@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Shiozaki |
Organization
Shinshu University School of Medicine
Division name
Department of Urology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2661
Homepage URL
m-shiozaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Urology, Shinshu University School of Medicine
Address
Nagano, Matsumoto, Asahi 3-1-1
Tel
0263372661
m-shiozaki@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 07 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2025 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 29 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a multicenter, retrospective observational study of patients with metastatic or locally advanced urothelial carcinoma (m/la UC) who received enfortumab vedotin plus pembrolizumab (EV+P) between November 2024 and January 2026 at five institutions: Shinshu University Hospital, Nagano Red Cross Hospital, Nagano Municipal Hospital, Saku Central Hospital Advanced Care Center, and Yamanashi Prefectural Central Hospital. Eligible patients will be identified through electronic medical records, and data on patient characteristics, tumor-related factors, treatment details, treatment efficacy, adverse events, and survival outcomes will be collected.
Management information
Registered date
| 2026 | Year | 07 | Month | 16 | Day |
Last modified on
| 2026 | Year | 07 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068882
