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

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT06041503
Phase
PHASE2
Status
Recruiting
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Conditions

  • Adenocarcinoma of the Bladder
  • Squamous Cell Carcinoma of the Bladder
  • Testicular Germ Cell Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Pembrolizumab — DRUG
    Pembrolizumab is administered IV at 200 mg on day 1 of each 21-day cycle.
  • Enfortumab vedotin — DRUG
    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).

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Jun 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1
    Treatment with enfortumab vedotin
  • Experimental: Arm 2
    Treatment with enfortumab vedotin and pembrolizumab

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: At every restaging (prior to every 2nd or 3rd cycle) until the end of the study therapy and during follow-up until PD ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
National Cancer Institute Referral Office
888-624-1937

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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