A Study of Enfortumab Vedotin in People With Urothelial Carcinoma of the Upper Urinary Tract
Trial Parameters
Brief Summary
The purpose of this study is to find out whether the study drug, enfortumab vedotin, is an effective and safe treatment for people who have urothelial carcinoma of the upper urinary tract. Study participants will be people who are not eligible to receive or have chosen not to receive the chemotherapy drug cisplatin for treatment of their cancer. In addition, all participants will be planning on having standard surgery to remove their tumor.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed high grade urothelial carcinoma of the upper tract and/or radiographically visible tumor stage T2-T4a N0/x M0 disease with positive selective urinary cytology. Hydronephrosis associated with tumor on imaging or biopsy will be considered invasive by definition. (Variant histology is acceptable if there is a predominant urothelial component. Discussion with PI strongly encouraged.) Retroperitoneal lymph nodes \<15 mm in the short axis will be eligible. * Patients who are o Ineligible for cisplatin based on any of the following criteria: * Estimated or calculated creatinine clearance ≥ 30ml/min but \< 60 ml/min * Grade 2 or above audiometric hearing loss (per CTCAE v5.0) or * Declined cisplatin-based neoadjuvant chemotherapy, as documented in medical chart * Availability of tumor specimen block, cell block or 30 unstained slides from diagnosis. Patients with fewer than 30 slides available may be enrolled after discussion with the Principal In