Actively Recruiting
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Led by Matthew Galsky · Updated on 2026-02-23
47
Participants Needed
5
Research Sites
238 weeks
Total Duration
On this page
Sponsors
M
Matthew Galsky
Lead Sponsor
S
Seagen Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
Enfortumab Vedotin Plus Pembrolizumab With Selective Bladder Sparing for Treatment of Muscle-invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization prior to registration
- Age 18 years or older at time of consent
- ECOG Performance Status of 0 to 1 within 28 days before registration
- Histologically confirmed clinically localized muscle-invasive urothelial cancer of the bladder, clinical stage T2-3N0M0
- Urothelial component of tumor at least 50%, with exceptions for squamous differentiation; no neuroendocrine histology
- No radiographically enlarged lymph nodes (no nodes 651 cm in short axis)
- Maximal transurethral resection of bladder tumor performed within 90 days prior to treatment start
- Adequate tumor tissue available for submission from TURBT
- Eligible for radical cystectomy and pelvic lymph node dissection
- Adequate organ function as defined by specified laboratory values within 28 days prior to registration
- Negative pregnancy test within 7 days prior to registration for females of childbearing potential
- Agreement to use contraception for females of childbearing potential and male participants able to father children
You will not qualify if you...
- Pre-existing sensory or motor neuropathy Grade 2 or higher
- Ongoing significant toxicity (Grade 2 or higher, except alopecia) from prior treatments
- Prior systemic chemotherapy for muscle-invasive urothelial bladder cancer
- Prior malignancy active within last 2 years except certain cured local cancers
- Prior radiation therapy for bladder cancer
- Hemoglobin A1c 8% or higher, or 7%-<8% with diabetes symptoms
- Active infection requiring systemic therapy
- Known active Hepatitis B or C infection (except resolved or controlled cases)
- Known active tuberculosis infection
- Pregnant or breastfeeding
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or related agents
- Recent live or live-attenuated vaccine within 30 days before study drug
- Immunodeficiency or recent systemic immunosuppressive therapy
- Severe hypersensitivity to pembrolizumab or enfortumab vedotin
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis/interstitial lung disease requiring steroids
- Conditions or abnormalities that may interfere with study participation or results
- History of allogenic tissue or solid organ transplant
- Current or recent participation in another investigational study within 28 days prior to registration
AI-Screening
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Trial Site Locations
Total: 5 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
4
Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
5
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
Actively Recruiting
Research Team
M
Matthew Galsky, MD
CONTACT
A
Ahran Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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