Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
Status:
Not yet recruiting
Trial end date:
2028-10-01
Target enrollment:
Participant gender:
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.