Urothelial Carcinoma
Conditions
Interventions
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
Sponsors
Kanazawa University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically confirmed locally advanced or metastatic urothelial carcinoma that is unresectable. Eastern Cooperative Oncology Group performance status of 0 to 2. Written informed consent to participate in this clinical study obtained voluntarily from the patient after sufficient explanation. Patients who agree to use adequate contraception: male patients from the initiation of study treatment until 1 month after the last dose, and female patients of childbearing potential from the initiation of study treatment until 4 months after the last dose.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactRyunosuke Nakagawa
Kanazawa University Urology
Outcome results
None listed