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An Open-Label, Single-Arm Phase II Study of Enfortumab Vedotin Plus Pembrolizumab in Patients with Unresectable Urothelial Carcinoma

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Urothelial Carcinoma
Date of first enrollment	2025/10/07
Target sample size	30
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	One treatment cycle consists of 42 days. Enfortumab vedotin is administered at a dose of 1.25 mg/kg on Days 1, 15, and 29, and pembrolizumab is administered at a fixed dose of 200 mg per body on Days 1 and 22.

Outcome(s)

Primary Outcome	ORR
Secondary Outcome	Overall survival Progression-free survival Time to performance status progression Disease control rate Safety Incidence of adverse events Duration of enfortumab vedotin treatment Duration of pembrolizumab treatment Discontinuation rate due to adverse events Relative dose intensity

Key inclusion & exclusion criteria

Age minimum	20years-old
Age maximum	100years-old
Gender	Male and Female
Include criteria
Exclude criteria	Patients who have received any prior systemic therapy for unresectable locally advanced or metastatic urothelial carcinoma. Patients with a history of hypersensitivity to enfortumab vedotin or to anti PD1 or anti PDL1 antibodies. Patients who have participated in another clinical study or clinical trial within 3 months prior to the initiation of study treatment. Patients with severe bone marrow suppression. Patients with active infection or suspected infection. Patients with severe hepatic impairment classified as Child Pugh class C. Patients with diabetes mellitus with poor glycemic control within 3 months prior to enrollment. Patients with end-stage renal disease receiving dialysis, or with an estimated glomerular filtration rate under 15 mL min Pregnant or breastfeeding women. Patients deemed inappropriate for participation in the study by the principal investigator or sub-investigators.