Study of EV for Recurrent Endometrial Carcinoma (NCT07139977) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study of EV for Recurrent Endometrial Carcinoma
United States12 participantsStarted 2026-04-01
Plain-language summary
This study is testing a drug called enfortumab vedotin in up to 12 patients with advanced endometrial (uterine) cancer that has worsened after previous treatments, including immunotherapy. The goal is to see how well the drug works and how safe it is. Patients will be treated for up to one year and followed over time to monitor their health and response to the treatment.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patient of age ≥18 years.
✓. Recurrent and progressive endometrial cancer, all stages at primary diagnosis. The histology types will be pending the preclinical assessments, but can include:
✓. Endometrioid endometrial carcinoma
✓. Serous endometrial carcinoma
✓. Prior standard of care of surgical intervention, including hysterectomy.
✓. Evidence of disease progression on or following the most recent line of therapy prior to screening. Therapy must include platinum-based chemotherapy. If the patient is eligible for immunotherapy, this must have been provided. Patient may have received either radiation therapy or hormone therapy, neither of which will be considered a line of therapy. Chemotherapy during radiotherapy will not be considered a line of therapy.
✓. Maximum of three prior lines of therapy. Neo-adjuvant and postsurgical therapy, if provided, will be counted as 1 line of therapy. Therapy given in a maintenance fashion after primary treatment will not be counted as a line of therapy.
✕. Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.
What they're measuring
1
Estimate the overall response rate (ORR)
Timeframe: 24 months
2
Evaluate the safety of enfortumab vedotin treatment
. Tumor sample does not express nectin-4 (local IHC testing).
✕. Symptomatic CNS metastases or leptomeningeal metastases. Patients with symptomatic brain metastasis must be treated and must be stable for at least 4 weeks prior to study treatment.
✕. Active second malignancy with anti-cancer treatments (except for treated in-situ carcinomas \[e.g., breast, cervix, bladder\], or basal or squamous cell carcinoma of the skin) within the past 24 months.
✕. Sensory or motor neuropathy ≥ G2
✕. Prior history of significant cardiovascular impairment within 12 months of the first dose of study drug: such as history of congestive heart failure greater than New York Heart Association (NYHA)Class II, unstable angina, myocardial infarction, or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability.
✕. Active infection requiring systemic IV antibiotics within 14 days, or oral antibiotics within 7 days, prior to administration of study drugs. Regular treatment of urinary tract infection (UTI) and/or topical treatment are allowed.