Study Comparing Sacituzumab Govitecan to Doctor's Choice Treatment in Endometrial Cancer Patients After Chemotherapy and Immunotherapy

Sponsor: Gilead Sciences

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06486441

Provider View

This clinical trial is testing a new drug, sacituzumab govitecan, to see how well it works compared to treatments chosen by doctors for patients with endometrial cancer who have already received chemotherapy and immunotherapy.

Patient Parameters

Program Overview

The purpose of this study is to determine how effective the drug sacituzumab govitecan (SG) is for patients with endometrial cancer who have previously been treated with platinum-based chemotherapy and immunotherapy. The study will compare SG to other treatments chosen by doctors to see which is better at stopping cancer from getting worse and improving overall survival.

Eligibility Criteria

Inclusion Criteria

  • Have recurrent or persistent endometrial cancer (endometrial carcinoma or carcinosarcoma).
  • Have had up to 3 previous treatments for endometrial cancer, including platinum-based chemotherapy and anti-PD-1/PD-L1 therapy.
  • Be eligible for treatment with either doxorubicin or paclitaxel, as decided by the study doctor.
  • Have cancer that can be evaluated by CT or MRI scans.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate organ function.

Exclusion Criteria

  • Have uterine leiomyosarcoma or endometrial stromal sarcomas.
  • Are candidates for treatments aimed at curing the cancer at the time of joining the study.
  • Are eligible to receive platinum-based chemotherapy again, as decided by the study doctor.
  • Have had any previous treatment with a Trop-2-directed antibody-drug conjugate (ADC).
  • Have another active cancer.
  • Have a serious infection that requires treatment with antibiotics.
  • Have active chronic inflammatory bowel disease or had a gastrointestinal perforation in the last 6 months.
  • Have a positive pregnancy test or are breastfeeding if assigned female at birth.

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