Actively Recruiting
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
Led by Emory University · Updated on 2025-07-28
25
Participants Needed
4
Research Sites
220 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial tests how well enfortumab vedotin (EV) and pembrolizumab works in treating patients with bladder cancer of variant histology (a group of less common types of bladder cancer) that have spread to nearby tissue or lymph nodes (locally advanced) or that has spread from where it first started (primary site) to other places in the body (metastatic). Enfortumab vedotin is a monoclonal antibody, enfortumab, linked to an anticancer drug called vedotin. Enfortumab attaches to a protein called nectin-4 on cancer 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. Giving enfortumab vedotin and pembrolizumab may kill more tumor cells in patients with locally advanced or metastatic bladder cancer of variant histology.
CONDITIONS
Official Title
Enfortumab Vedotin Plus Pembrolizumab for the Treatment of Locally Advanced or Metastatic Bladder Cancer of Variant Histology
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or Female
- Age 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score of 70% or higher)
- Metastatic disease or unresectable locally advanced bladder cancer
- Histologically confirmed variant histology or non-urothelial bladder cancer of epithelial origin including squamous cell carcinoma and adenocarcinoma
- Variant histology tumors or non-urothelial tumors of ureter, urethra, urachus, or renal pelvis included
- Mixed cell type tumors eligible if variant or non-urothelial histology is predominant (over 50%)
- Untreated or previously treated with any number of prior therapies
- Available tumor tissue samples for submission or willingness to undergo biopsy before treatment
- Measurable disease by RECIST 1.1 criteria on CT or MRI
- Adequate organ and marrow function within 28 days before starting treatment
- Negative pregnancy test for females of child-bearing potential before therapy
- Agreement to use effective contraception during study and for 6 months after last dose for females of child-bearing potential and male participants
- Completed all previous cancer therapies at least 4 weeks before starting this study
- Life expectancy longer than 12 weeks
- Willingness and ability to comply with study procedures and visits
- Signed informed consent acknowledging understanding of the disease and study procedures
You will not qualify if you...
- Neuroendocrine histology tumors (small cell and large cell carcinomas) and non-epithelial bladder tumors (e.g., sarcoma, carcinosarcoma, paraganglioma, melanoma, lymphoma)
- Chemotherapy or radiotherapy within 4 weeks prior to study or unresolved side effects from prior treatments
- Receiving other investigational agents or devices within 21 days prior to first study dose
- History of allergic reactions to similar drugs used in this study
- Ongoing sensory or motor neuropathy grade 2 or higher
- Prior treatment with enfortumab vedotin or PD-1/PD-L1 immune checkpoint inhibitors
- Uncontrolled diabetes with high HbA1c or associated symptoms
- Active central nervous system metastases
- Other active malignancies within last 24 months except certain localized or treated cancers
- Current systemic antimicrobial treatment for infection or high dose steroids above 10 mg prednisone equivalent
- Positive pregnancy test or breastfeeding females
- History of active autoimmune disease requiring systemic treatment in past 2 years
- Known active hepatitis B or C or tuberculosis
- History of active keratitis or corneal ulcerations
- History of allogenic tissue or solid organ transplant
- Severe heart failure, unstable angina, or serious heart arrhythmias within 6 months
- Other uncontrolled illnesses or psychiatric/social conditions limiting study compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Grady Health System
Atlanta, Georgia, United States, 30303
Actively Recruiting
2
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
3
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Emory Saint Joseph's Hospital
Atlanta, Georgia, United States, 30342
Actively Recruiting
Research Team
J
Jacqueline Brown, MD
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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