Actively Recruiting
Phase II Study of Enfortumab Vedotin Plus Pembrolizumab for Locally Advanced or Metastatic Bladder Cancer of Variant Histology
Led by Emory University · Updated on 2025-07-28
25
Participants Needed
4
Research Sites
52 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
Researchers are evaluating the combination of enfortumab vedotin and pembrolizumab to treat patients with bladder cancer of variant histology that is either locally advanced or has spread to other parts of the body. This phase II trial aims to assess how well this combination works by measuring tumor response, progression, survival, and safety in this specific group of bladder cancer patients. The study also investigates biological markers related to immune cells and inflammation. Participants receive intravenous infusions of enfortumab vedotin and pembrolizumab. Throughout the trial, patients undergo imaging tests like CT scans or MRIs and have blood samples collected to monitor their response to treatment and study biological changes. The trial includes evaluations up to two years, during which tumor response and safety are closely tracked. During the study, participants will have regular visits for drug administration, imaging scans, blood collection, and questionnaires. Researchers will measure overall tumor response rate, progression-free survival, overall survival, duration of response, and record any adverse events for up to two years. Participants must agree to comply with all procedures and follow-up requirements during the study period.
CONDITIONS
Brief 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 aged 18 years or older
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (Karnofsky score ≥ 70%)
- Metastatic or unresectable locally advanced bladder cancer of variant histology or non-urothelial bladder cancer of epithelial origin
- Histological confirmation of variant or non-urothelial bladder cancer subtypes following 2016 WHO classifications
- Untreated or previously treated with any number of therapy lines
- Availability of tumor tissue samples for submission prior to study treatment or agreement to undergo biopsy
- Measurable disease by RECIST 1.1 criteria on CT or MRI
- Adequate organ and marrow function within 28 days before treatment start
- Negative pregnancy test for females of child-bearing potential prior to therapy
- Agreement to use contraception during and for 6 months after study participation if applicable
- Completion of previous cancer therapy at least 4 weeks before starting study treatment
- Life expectancy greater than 12 weeks
- Willingness and ability to comply with study visits, drug administration, tests, and procedures
- Signed informed consent acknowledging study details and risks
You will not qualify if you...
- Neuroendocrine histology (small cell and large cell carcinomas) and non-epithelial bladder tumors
- Chemotherapy or radiotherapy within 4 weeks prior to study or unresolved adverse events from prior treatments
- Use of other investigational agents or devices within 21 days before first study dose
- History of allergic reactions to similar compounds as study drugs
- Ongoing sensory or motor neuropathy grade 2 or higher
- Prior treatment with enfortumab vedotin or PD1/PD-L1 immune checkpoint inhibitors
- Uncontrolled diabetes mellitus with HbA1c ≥ 8% or HbA1c 7% to <8% with symptoms
- Active central nervous system metastases
- Other active malignancies within past 24 months except certain localized cancers
- Current systemic antimicrobial treatment or high-dose steroids (>10mg prednisone equivalent)
- Positive pregnancy test or breastfeeding females
- History of active autoimmune disease requiring systemic treatment in past 2 years
- Known active hepatitis B, hepatitis C infection, or tuberculosis
- History of active keratitis or corneal ulcerations
- History of allogenic tissue or solid organ transplant
- Severe heart conditions or serious cardiac arrhythmias within 6 months prior to study
- Other uncontrolled illnesses including psychiatric or social issues limiting compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years or until disease progression or discontinuation
Participants receive enfortumab vedotin and pembrolizumab intravenously. They also undergo CT or MRI scans and blood collections throughout the treatment period.
Regular visits for drug administration and assessments throughout treatment
Duration - Up to 2 years after treatment initiation
Participants are monitored for safety and efficacy outcomes including adverse events, progression-free survival, and overall survival after treatment ends.
Visits as scheduled for safety and outcome assessments
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
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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