Study on Enfortumab Vedotin for Recurrent Endometrial Cancer

Sponsor: William Bradley

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07139977

Provider View

This clinical trial is testing a drug called enfortumab vedotin in women with advanced endometrial cancer that has worsened after previous treatments, including immunotherapy. The study aims to see how well the drug works and how safe it is. Participants will receive treatment for up to one year and be monitored over time to check their health and response to the treatment.

Patient Parameters

Program Overview

This study is exploring the use of a drug called enfortumab vedotin in women with advanced or metastatic endometrial cancer that has progressed after previous chemotherapy and immunotherapy treatments. The main goals are to evaluate how effective the drug is and to ensure it is safe for patients. Participants will receive the treatment for up to 12 months or until their cancer progresses, they experience unacceptable side effects, or they choose to stop. Those who show stable disease or improvement may continue treatment unless they experience side effects or decide to stop. Patients who stop treatment for reasons other than cancer progression will be monitored for disease status until progression.

Description

This clinical trial is an open-label, single-arm Phase II study, meaning all participants will receive the same treatment, and both the researchers and participants know what treatment is being given. The study is designed to evaluate the effectiveness and safety of enfortumab vedotin in up to 12 women with advanced endometrial cancer that has worsened after previous treatments, including chemotherapy and immunotherapy. Participants will receive the drug for up to one year, unless their cancer progresses, they experience severe side effects, or they choose to stop. If the cancer remains stable or improves, participants may continue treatment unless they experience side effects or decide to stop. Those who stop treatment for reasons other than cancer progression will be monitored for disease status until progression.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 years or older.
  • Have recurrent and progressive endometrial cancer, including types like endometrioid or serous endometrial carcinoma.
  • Have had previous standard treatments, including surgery like hysterectomy.
  • Show evidence of cancer progression after the most recent therapy, which must include platinum-based chemotherapy and, if eligible, immunotherapy.
  • Have received no more than three prior lines of therapy.
  • Cancer cells must express a protein called nectin-4.
  • Have recovered from side effects of previous treatments to a mild level.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Have documented tumor status for specific genetic markers (MSI and MMR).
  • Have a life expectancy of at least 12 weeks and be well enough to receive experimental therapy.
  • Have adequate organ function as determined by specific blood tests.
  • Be able to understand and sign a written informed consent document.
  • Agree to use effective contraception during and after the study to prevent pregnancy.

Exclusion Criteria

  • Have a diagnosis of endometrial sarcoma or other non-eligible types of endometrial cancer.
  • Tumor does not express the nectin-4 protein.
  • Have active or untreated brain metastases.
  • Have another active cancer requiring treatment within the past 24 months, except for certain non-threatening cancers.
  • Have significant nerve damage or neuropathy.
  • Have had serious heart problems within the past year.
  • Have an active infection requiring antibiotics shortly before starting the study.
  • Have uncontrolled diabetes.
  • Have hepatitis B, C, or HIV infection.
  • Have not recovered from side effects of previous treatments to a mild level.
  • Are currently receiving treatment for endometrial cancer, unless it was stopped at least four weeks before screening.
  • Have an active intestinal blockage.
  • Have psychiatric or substance use disorders that would interfere with the study.
  • Require systemic immunosuppressive therapy shortly before starting the study.
  • Are pregnant or breastfeeding.
  • Have any condition or abnormality that might interfere with the study or not be in the patient's best interest, as determined by the investigator.

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