Study of EV for Recurrent Endometrial Carcinoma
ConditionEndometrial Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWilliam Bradley
About this trial
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.
Eligibility criteria
Qualifiers
Female patient of age ≥18 years.
Endometrioid endometrial carcinoma
Serous endometrial carcinoma
Prior standard of care of surgical intervention, including hysterectomy.
Disqualifiers
Diagnosis of endometrial sarcoma (leiomyosarcoma, endometrial stromal sarcoma, high-grade sarcoma).
Diagnosis of non-endometrioid and non-serous endometrial cancer. Mixed tumors involving histologic types other than serous and endometrioid will not be eligible.
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.
Trial design
Treatments tested in this trial
- Enfortumab Vedotin
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
William Bradley
Lead sponsor
Medical College of Wisconsin
Sponsor institution
Astellas Pharma Inc
Collaborator
Source ClinicalTrials.gov