University of Utah
The purpose of this study is to evaluate whether Enfortumab Vedotin in combination with Pembrolizumab can achieve a clinical response that preserves the bladder and avoids the need for cystectomy or radiation therapy in patients with urothelial cancer.
Inclusion Criteria: * Participant aged ≥ 18 years. * Disease criteria: * Histologically confirmed muscle-invasive urothelial carcinoma (T2-T3N0M0) without small cell variant histology of bladder. Other variant histologies are allowed if urothelial histology is present. * No evidence of local or distant metastasis on CT scans. * Urothelial carcinomas not originating from the bladder (eg, upper tract \[ureters, renal pelvis\], urethra) are not eligible. * Eligible to receive enfortumab vedotin and pembrolizumab. * ECOG Performance Status ≤ 2. * Adequate organ function as defined as: *…
Enfortumab vedotin 1.25 mg/kg, IV on days 1 and 8 on a 21day cycle for 9 cycles
Subjects will receive one year of treatment with pembrolizumab IV or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) SC. Treatment will be administered per institutional standards every 3 weeks or 6 weeks, at the physician's discretion.
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