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.
Participant aged ≥ 18 years.
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.
Prior systemic therapy for urothelial cancer.
Receiving other systemic investigational agents for urothelial cancer.
Hemoglobin A1c > 8% or 7-8% with associated diabetes symptoms.
Autoimmune disease requiring systemic steroids or immunosuppressive agents in the last 2 years.
Single group
Enfortumab vedotin
DrugEnfortumab vedotin 1.25 mg/kg, IV on days 1 and 8 on a 21day cycle for 9 cycles
Pembrolizumab
DrugSubjects 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.
cT0 or cTa low-grade disease as assessed by cystoscopy and bladder biopsy, including all visually abnormal sites in addition to reTURBT or biopsy of the known site of MIBC before neo- adjuvant therapy
To assess the proportion of patients who have achieved a clinical complete response and have maintained bladder preservation without undergoing definitive treatment of cystectomy or radiation after 4 cycles of study treatment.
Negative tumor-informed ctDNA
To assess the proportion of patients who have achieved a clinical complete response and have maintained bladder preservation without undergoing definitive treatment of cystectomy or radiation after 4 cycles of study treatment.
The absence of malignant cells on urine cytology
To assess the proportion of patients who have achieved a clinical complete response and have maintained bladder preservation without undergoing definitive treatment of cystectomy or radiation after 4 cycles of study treatment.
No definitive evidence of new local or metastatic disease at cross-sectional imaging per investigator judgement
To assess the proportion of patients who have achieved a clinical complete response and have maintained bladder preservation without undergoing definitive treatment of cystectomy or radiation after 4 cycles of study treatment.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type.
To assess the safety and tolerability of enfortumab vedotin in combination with pembrolizumab in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by severity (as defined by the NIH CTCAE, version 6.0).
To assess the safety and tolerability of enfortumab vedotin in combination with pembrolizumab in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by seriousness.
To assess the safety and tolerability of enfortumab vedotin in combination with pembrolizumab in the study population.
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by duration.
To assess the safety and tolerability of enfortumab vedotin in combination with pembrolizumab in the study population.
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