RecruitingPhase 2NCT06041503

Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)

A Phase II Multicenter Study of Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)


Sponsor

National Cancer Institute (NCI)

Enrollment

68 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is testing two drugs — enfortumab vedotin (alone or combined with pembrolizumab) — for rare types of urinary tract cancers (including squamous cell or adenocarcinoma of the bladder/urinary tract) and treatment-resistant testicular cancer that have few other options. **You may be eligible if...** - You have confirmed locally advanced or metastatic squamous cell carcinoma or adenocarcinoma of the urinary tract, or relapsed/refractory testicular germ cell tumors - Your cancer is measurable on imaging scans - You have received prior treatment including anti-PD-1/PD-L1 therapy (depending on which group of the study you enroll in) - Your overall health and organ function are within acceptable ranges **You may NOT be eligible if...** - You have significant uncontrolled medical conditions - You have active autoimmune disease that requires treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembrolizumab is administered IV at 200 mg on day 1 of each 21-day cycle.

DRUGEnfortumab vedotin

EV is administered IV at 1.25 mg/kg on days 1, 8, and 15 of each 28-day cycle (Arm 1) and on days 1 and 8 of each 21-day cycle (Arm 2).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06041503


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