NIPH Clinical Trials Search

Biweekly Combination therapy of Urothelial carcinoma with Regimen Evaluation

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients with unresectable urothelial carcinoma
Date of first enrollment	19/11/2025
Target sample size	30
Countries of recruitment
Study type	Interventional
Intervention(s)	One treatment cycle is defined as 42 days. Enfortumab vedotin will be administered at 1.25 mg/kg on Days 1, 15, and 29, and pembrolizumab at 200 mg/body on Days 1 and 22. For patients deemed by the physician to be at low risk for adverse events, pembrolizumab may alternatively be administered at 400 mg/body every 6 weeks. Pembrolizumab treatment will be continued for up to a maximum of 2 years.

Outcome(s)

Primary Outcome	objective response rate
Secondary Outcome	Overall Survival (OS) Progression-Free Survival (PFS) Time to Performance Status Progression Disease Control Rate (DCR) Incidence of Adverse Events (AEs) Safety Profile Duration of Enfortumab Vedotin Treatment Duration of Pembrolizumab Treatment Time to Initiation of Opioid Use for 7 Consecutive Days

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Both
Include criteria	Patients with unresectable locally advanced or metastatic urothelial carcinoma Aged 20 years or older Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2 Patients who have provided written informed consent of their own free will after receiving sufficient explanation regarding participation in the clinical study Male patients who agree to use contraception from the start of study treatment until one month after the last dose, and female patients of childbearing potential who agree to use contraception from the start of study treatment until four months after the last dose
Exclude criteria	Patients who have previously received any systemic therapy for unresectable locally advanced or metastatic urothelial carcinoma Patients with a history of hypersensitivity to enfortumab vedotin or antiPD-1,PDL1 antibodies Patients who have participated in another clinical trial within 3 months prior to the initiation of study drug administration Patients with severe bone marrow suppression Patients with a concomitant or suspected infection Patients with severe hepatic impairment Patients with poorly controlled diabetes mellitus within 3 months prior to enrollment Patients with end-stage renal disease undergoing dialysis Pregnant or breastfeeding women Patients deemed inappropriate for study participation by the principal investigator or subinvestigator