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NCT06041503 · ClinicalTrials.gov registry record · Phase 2
Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)
A Phase 2 study of Squamous Cell Carcinoma of the Bladder and Adenocarcinoma of the Bladder, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 68
- Enrollment target
- 1
- Study location
NCT06041503: Recruiting Phase 2 study of Squamous Cell Carcinoma of the Bladder and Adenocarcinoma of the Bladder, sponsored by National Cancer Institute (NCI).
NCT06041503 is a Phase 2 study of Squamous Cell Carcinoma of the Bladder and Adenocarcinoma of the Bladder that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 68 participants. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06041503, a Phase 2 study of Squamous Cell Carcinoma of the Bladder and Adenocarcinoma of the Bladder, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 68 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Enfortumab vedotin
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2026-01-20 |
| Est. Completion | 2028-10-01 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06041503
The ClinicalTrials.gov registry entry for NCT06041503 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Squamous Cell Carcinoma of the Bladder appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT06041503 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT06041503 about?
NCT06041503 is a clinical study titled "Enfortumab Vedotin With or Without Pembrolizumab in Rare Genitourinary Tumors (E-VIRTUE)". 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 app...
What is the current status of trial NCT06041503?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2026-01-20. Estimated completion is 2028-10-01.
What conditions does trial NCT06041503 study?
This clinical trial studies the following conditions: Squamous Cell Carcinoma of the Bladder, Adenocarcinoma of the Bladder, Testicular Germ Cell Tumors.
What interventions are being tested in trial NCT06041503?
The interventions under investigation include: Pembrolizumab (DRUG), Enfortumab vedotin (DRUG).
Who is sponsoring clinical trial NCT06041503?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06041503 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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