Actively Recruiting
Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
Led by National Cancer Institute (NCI) · Updated on 2026-05-12
68
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: Many cancers of the testicles and urinary tract are rare diseases; these are diseases that affect less than 200,000 people in the United States. It can be hard to study treatments for these diseases. One combination of drugs-enfortumab vedotin (EV) and pembrolizumab-has already been approved to treat some urinary cancers. Researchers want to see if they can help people with other types of testicle and urinary cancers. Objective: To test EV, with or without pembrolizumab, in patients with rarer cancers of the testicles or urinary tract. Eligibility: People aged 18 and older with rarer cancers of the testicles or urinary tract. Design: Participants will be screened. They will have a physical exam with blood and urine tests. Their ability to perform normal daily activities will be tested. They will have exams of their skin and eyes. They will have imaging scans. A biopsy may be needed: A sample of tissue will be removed from the tumor. The study drugs are both given through a tube attached to a needle inserted into a vein in the arm. Some participants will receive treatments 3 times during 28-week cycles; others will receive treatments 2 times during 21-day cycles. All participants may continue to receive treatments for up to 5 years. Imaging scans and other tests will be repeated. Participants who stop taking the drugs will have follow-up visits every 3 to 4 weeks until the disease gets worse. They will have imaging scans and blood tests. After that, follow-up visits will continue by phone every 3 months for up to 5 years after study therapy is finished.
CONDITIONS
Official Title
Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed locally advanced or metastatic pure adenocarcinoma or squamous cell carcinoma of the urinary tract, or treatment-refractory testicular germ cell tumors
- Measurable disease according to RECIST 1.1
- Locally advanced or metastatic disease with new or progressive lesions on imaging
- Prior anti-PD-1/PD-L1 therapy for cohorts A1, B1, C1; no prior anti-PD-1/PD-L1 therapy for cohorts A2, B2, C2
- Participants may be treatment naive except testicular germ cell tumor patients who must have exhausted standard curative treatments
- Eastern Cooperative Oncology Group performance status 0 or 1 (Karnofsky ≥ 70%)
- Adequate organ and marrow function including hemoglobin ≥ 9 g/dL, ANC ≥ 1,500/mcL, platelets ≥ 100,000/mcL, bilirubin ≤ 1.5x ULN, AST/ALT ≤ 2.5x ULN, and creatinine clearance ≥ 30 mL/min/1.73m²
- Availability of sufficient pre-study tumor tissue or willingness to undergo biopsy
- HIV positive participants stable on therapy with CD4 > 200 and undetectable viral load
- HBV or HCV positive participants appropriately treated and monitored
- Women of childbearing potential and men able to father children agree to use effective contraception
- Willingness to discontinue breastfeeding during and after study treatment
- Ability and willingness to provide informed consent
You will not qualify if you...
- Prior investigational drugs, chemotherapy, immunotherapy, or radiotherapy (except palliative bone therapy) within 2 weeks before study drug
- Prior treatment with enfortumab vedotin or other MMAE-based antibody-drug conjugates
- Preexisting sensory or motor neuropathy Grade ≥ 2
- History of severe allergic reactions to similar compounds as enfortumab vedotin or pembrolizumab
- Symptomatic or untreated central nervous system metastases
- Active autoimmune diseases that could worsen with pembrolizumab except specified conditions
- Use of systemic corticosteroids or immunosuppressive agents beyond allowed doses
- Uncontrolled diabetes mellitus within 3 months before first dose
- Active keratitis or corneal ulcerations
- Receipt of live vaccines within 30 days prior to first study drug administration
- Pregnant women
- Severe uncontrolled illnesses limiting study compliance
- Prior or concurrent malignancies that may interfere with safety or efficacy assessments unless stable and not interfering with study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
L
Lisa Ley, R.N.
CONTACT
A
Andrea B Apolo, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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