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

NCT06041503 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2026-05-22

No results posted yet for this 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

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

Interventions

DRUG

Pembrolizumab

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

DRUG

Enfortumab 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).

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Andrea B Apolo, M.D. · National Cancer Institute (NCI)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2027-10-01
Completion
2028-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06041503 on ClinicalTrials.gov