Actively Recruiting
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
Led by University of California, San Francisco · Updated on 2026-02-18
47
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
A
Astellas Pharma Inc
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib/II trial studies the side effects, best dose, and effectiveness of enfortumab vedotin (EV) in combination with pembrolizumab and radiation therapy for treating patients with muscle invasive bladder cancer. Standard of care treatment for muscle invasive bladder cancer is chemotherapy, to shrink the tumor before the main treatment is given (neoadjuvant), followed by surgery to remove all of the bladder as well as nearby tissues and organs (radical cystectomy). In cases where patients are not candidates for the standard of care approach or prefer a bladder sparing option, tri-modality therapy with transurethral resection of bladder tumor (TURBT) followed by combined chemotherapy and radiation therapy is used. Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. It works by helping the immune system to slow or stop the growth of tumor cells. Enfortumab attaches to a protein called nectin-4 on tumor cells in a targeted way and delivers vedotin to kill them. It is a type of antibody-drug conjugate. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Intensity-modulated radiation therapy is a type of 3-dimensional radiation therapy that uses computer-generated images to show the size and shape of the tumor. Thin beams of radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor. Giving enfortumab vedotin with pembrolizumab and radiation therapy may work better in treating patients with muscle invasive bladder cancer.
CONDITIONS
Official Title
Enfortumab Vedotin and Pembrolizumab Combined With Radiotherapy in Muscle Invasive Bladder Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed muscle-invasive bladder cancer (cT2,T3,T4a) with urothelial histology (mixed histologies allowed except neuroendocrine)
- Ineligible for or electing not to undergo radical cystectomy
- Eligible for bladder irradiation and agree to receive it
- Underwent transurethral resection of bladder tumor (TURBT) within 8 weeks with viable tumor
- No active autoimmune disease requiring high-dose immunosuppression (corticosteroids >10 mg prednisone daily)
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate blood counts and liver/kidney function within defined limits
- Ability and willingness to sign informed consent
- HIV patients on effective antiretroviral therapy with undetectable viral load within 6 months
- Hepatitis B patients on antiviral therapy with undetectable viral load
- Hepatitis C patients with undetectable viral load after curative therapy
- Women of childbearing potential and men with partners using effective contraception during and after treatment
- Men agree to use contraception during and after treatment
You will not qualify if you...
- Presence of distant metastases (M1) or extensive lymph node disease (N2 or higher)
- Small cell or neuroendocrine tumor histology
- Absence of urothelial histology (pure variant histology)
- Untreated upper tract urothelial cancer
- Severe hydronephrosis preventing therapy
- Extensive carcinoma in situ (CIS) excluding moderate CIS eligible for radiation
- Baseline neuropathy grade 2 or higher
- Uncontrolled diabetes mellitus (HbA1c ≥8% or 7-<8% with symptoms)
- Prior systemic immunotherapy or chemotherapy for urothelial cancer within 12 months
- Recent systemic anti-cancer therapy within 4 weeks or radiotherapy within 2 weeks
- Recent live vaccine within 30 days prior to treatment
- Major surgery within 2 weeks prior to treatment (exceptions apply)
- Immunodeficiency or systemic immunosuppression exceeding allowed doses
- HIV with history of Kaposi's sarcoma or Multicentric Castleman's Disease
- Active CNS metastases or carcinomatous meningitis
- Recent significant other malignancies requiring treatment within 2 years
- Hypersensitivity to study drugs or components
- Prior allogeneic stem cell or solid organ transplant
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active infection requiring systemic therapy
- Conditions or abnormalities interfering with study participation
- Detectable hepatitis B viral load or active hepatitis C infection
- Psychiatric or substance abuse disorders interfering with trial cooperation
- Pregnant or breastfeeding women due to potential risks of treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
U
UCSF Genitourinary Medical Oncology Recruitment
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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