Tokyo, July 17 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062258) titled 'Initial Real-World Experience of Enfortumab Vedotin Combined with Pembrolizumab for Unresectable Urothelial Carcinoma in Shinshu University-Affiliated Centers' on July 16.
Study Type:
Observational
Primary Sponsor:
Institute - Shinshu University
Condition:
Condition - metastatic/unresectable Urothelial carcinoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
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
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 Size - 60
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068882
Disclaimer: Curated by HT Syndication.
