Tokyo, Jan. 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060270) titled 'An Open-Label, Single-Arm Phase II Study of Enfortumab Vedotin Plus Pembrolizumab in Patients with Unresectable Urothelial Carcinoma' on Jan. 6.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Historical

Primary Sponsor: Institute - Kanazawa University

Condition: Condition - Urothelial Carcinoma Classification by malignancy - Malignancy Genomic information - NO

Objective: Narrative objectives1 - To evaluate the efficacy of enfortumab vedotin in combination with pembrolizumab in patients with unresectable urothelial carcinoma, with the objective response rate (ORR) as the primary efficacy endpoint. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - 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.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key 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. Key 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. Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 07 Day Date of IRB - 2025 Year 10 Month 07 Day Anticipated trial start date - 2025 Year 10 Month 07 Day Last follow-up date - 2033 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068941

Disclaimer: Curated by HT Syndication.