Status and phase
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About
Patients with MIBC will receive 3 cycles (C1-C3) of induction enfortumab vedotin plus pembrolizumab followed by restaging including MRI of the bladder, urine cytology, and cystoscopy with TURBT of any visible tumor and/or resection site plus random biopsies using a recommended template. Patients achieving a stringently defined cCR (clinical complete response) will receive 14 cycles of "maintenance" treatment. Enfortumab vedotin will be administered during the first 6 cycles (C4-C9) of "maintenance" treatment and pembrolizumab will be given all 14 cycles (C4-C14). Patients with any residual disease at clinical restaging (i.e., >cTa disease) will undergo cystectomy.
Enrollment
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Volunteers
Inclusion criteria
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
ECOG Performance Status of 0-1 within 28 days prior to registration.
Histological evidence of clinically localized muscle-invasive urothelial cancer of the bladder. Participants with mixed histology are eligible provided the urothelial component is ≥50% (participants whose tumors contain any component of neuroendocrine histology are not eligible). Clinical stage cT2-3N0M0. N0 will be considered the absence of radiographically enlarged lymph nodes on baseline imaging. Patients with lymph nodes <1 cm on imaging may be eligible but must be discussed with the sponsor investigator.
Have undergone a standard of care maximal transurethral resection of bladder tumor ≤ 60 days prior C1D1. Maximal TURBT is defined as a macroscopically complete resection of bladder tumor when safely possibly per the treating urologist. Patients who cannot safely undergo maximal TURBT as per their treating urologist are eligible for enrollment but should be discussed with the sponsor investigator.
All subjects must have adequate transurethral resection of bladder tumor tissue available for submission (i.e., at least 15 unstained slides or paraffin block) identified during screening. The specimen must include tumor tissue (i.e., if the restaging maximal TURBT was performed and there was no cancer in the specimen, tissue from the most recent prior TURBT that established the diagnosis of muscle-invasive urothelial cancer of the bladder should be submitted). Tissue from both the restaging maximal TURBT and the prior diagnostic TURBT may be requested. Subjects without available archival tissue must be discussed with the sponsor-investigator.
Be deemed eligible to undergo radical cystectomy and pelvic lymph node dissection
Demonstrate adequate organ function as defined below. All screening labs to be obtained within 28 days prior to registration.
Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days prior to registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. WOCBP must agree to use contraception.
Male participants able to father a child who are sexually active with female of childbearing potential must be willing to use an effective method(s) of contraception.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
47 participants in 1 patient group
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Central trial contact
Matthew Galsky, MD; Ahran Lee
Data sourced from clinicaltrials.gov
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