Enfortumab Vedotin for Endometrial Cancer
(EV-4-EC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests enfortumab vedotin, an antibody-drug conjugate, to evaluate its effectiveness for women with advanced endometrial cancer that has progressed after other treatments, including immunotherapy. The trial aims to determine the drug's safety and effectiveness over up to one year. Women whose endometrial cancer has returned or worsened after previous treatments, such as surgery and chemotherapy, may qualify. Participants will receive the drug on a structured schedule and undergo close monitoring for response and health. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, ongoing treatment for endometrial cancer must be stopped at least 4 weeks before screening, and there should be no plan to restart it during the study.
Is there any evidence suggesting that enfortumab vedotin is likely to be safe for humans?
Research has shown that enfortumab vedotin has been tested in other cancers, such as bladder cancer, with most patients tolerating the treatment without severe side effects. One study tested enfortumab vedotin with another drug, KEYTRUDA, for varying durations, providing insights into its long-term safety.
When a treatment reaches a Phase 2 study, like enfortumab vedotin for endometrial cancer, it indicates existing evidence of safety from earlier studies. This phase focuses more on the treatment's effectiveness while still monitoring safety closely. It's important to remember that every treatment can have side effects, and these trials help identify what those might be and how often they occur.12345Why do researchers think this study treatment might be promising for endometrial cancer?
Unlike the standard treatments for endometrial cancer, which often involve surgery, radiation, and chemotherapy, Enfortumab Vedotin offers a novel approach by targeting a specific protein found on cancer cells. This drug is an antibody-drug conjugate, meaning it combines an antibody with a cancer-killing agent to deliver treatment directly to cancer cells, potentially minimizing damage to healthy cells. Researchers are excited about Enfortumab Vedotin because it may provide a more targeted treatment option with fewer side effects, and it could be effective in cases where other treatments have failed.
What evidence suggests that enfortumab vedotin might be an effective treatment for endometrial cancer?
Research has shown that enfortumab vedotin, a type of targeted cancer treatment, holds potential for treating certain cancers. In earlier studies, it shrank or controlled cancer in 37.1% of patients with tumors expressing HER2, a specific protein. This drug delivers a cancer-fighting substance directly to cancer cells, helping to protect healthy cells. Although information on its effects on endometrial cancer remains limited, these early results are promising. Further research, including this single-arm trial, will help confirm these findings.12678
Who Is on the Research Team?
William Bradley, MD
Principal Investigator
Medical College of Wiscnson
Are You a Good Fit for This Trial?
This trial is for up to 12 patients with advanced endometrial cancer that has progressed despite prior treatments, including immunotherapy. Participants will receive treatment for up to a year and be monitored over time.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enfortumab vedotin monotherapy for up to 12 months or until disease progression, unacceptable toxicity, or patient withdrawal
Follow-up
Participants are monitored for disease status and overall survival after treatment discontinuation
What Are the Treatments Tested in This Trial?
Interventions
- Enfortumab Vedotin
Find a Clinic Near You
Who Is Running the Clinical Trial?
William Bradley
Lead Sponsor
Astellas Pharma Inc
Industry Sponsor
Tadaaki Taniguchi
Astellas Pharma Inc
Chief Medical Officer since 2023
MD, PhD
Naoki Okamura
Astellas Pharma Inc
Chief Executive Officer since 2023
University of Tokyo, Faculty of Pharmacy