Study on Enfortumab Vedotin With or Without Pembrolizumab for Rare Testicular and Urinary Tract Cancers (E-VIRTUE)

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0

ClinicalTrials ID:NCT06041503

Provider View

This clinical trial is exploring the use of enfortumab vedotin, with or without pembrolizumab, to treat rare cancers of the testicles and urinary tract. The study aims to determine if these drugs can help control these uncommon cancers.

Patient Parameters

Program Overview

This study is investigating whether the drug enfortumab vedotin, alone or combined with pembrolizumab, can effectively treat rare cancers of the testicles and urinary tract. These cancers are uncommon, affecting fewer than 200,000 people in the U.S., making it challenging to study treatments. Enfortumab vedotin and pembrolizumab are already approved for some urinary cancers, and researchers want to see if they can help with other types as well.

Description

This study focuses on rare cancers in the urinary tract and testicles, which are not commonly included in large clinical trials due to their rarity. The drugs being tested, enfortumab vedotin and pembrolizumab, have shown promise in treating other urinary cancers. Enfortumab vedotin targets a protein called nectin-4, which is often found in cancer cells, while pembrolizumab helps the immune system attack cancer cells.

Participants will be divided into groups based on their cancer type and previous treatments. Some will receive enfortumab vedotin alone, while others will receive it with pembrolizumab. The treatment cycles vary, with some receiving drugs every 21 days and others every 28 days. The study will last up to 5 years, with regular imaging scans and tests to monitor progress.

Participants who stop treatment will have follow-up visits every 3 to 4 weeks until their disease worsens, and then follow-up by phone every 3 months for up to 5 years.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 and older with rare cancers of the testicles or urinary tract.
  • Must have a confirmed diagnosis of advanced or metastatic adenocarcinoma or squamous cell carcinoma of the urinary tract, or treatment-resistant testicular germ cell tumors.
  • Must have measurable disease as shown by imaging scans.
  • Must have received prior anti-PD-1/PD-L1 therapy if in certain study groups.
  • Must have adequate organ and bone marrow function, as shown by specific blood tests.
  • Must provide a tissue sample for study purposes.
  • HIV-positive participants must be on stable antiretroviral therapy.
  • Hepatitis B or C positive participants must be on appropriate antiviral treatment.
  • Women of childbearing potential and men must agree to use effective contraception during the study and for a period after the last dose.
  • Must be willing to sign an informed consent document.

Exclusion Criteria

  • Recent treatment with investigational drugs, chemotherapy, or immunotherapy within 2 weeks before starting the study.
  • Previous treatment with enfortumab vedotin or similar drugs.
  • Severe allergic reactions to similar drugs.
  • Active or untreated brain or central nervous system metastases.
  • Active autoimmune diseases that could worsen with pembrolizumab, except for certain stable conditions.
  • Uncontrolled diabetes or active eye infections.
  • Recent live vaccinations.
  • Pregnant women or those with severe uncontrolled illnesses.

Locations

FACILITYZIPCITYSTATE
National Institutes of Health Clinical Center20892BethesdaMaryland

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