Patients with unresectable urothelial carcinoma transitional cell carcinoma
Conditions
Interventions
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 ph
Enfortumab Vedotin, pembrolizumab
Sponsors
Izumi Kouji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| objective response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactRyunosuke Nakagawa
Kanazawa University Graduate School of Medical Science
Outcome results
None listed