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A Phase 3 Randomized Open-Label Study of Sacituzumab Govitecan Versus Physician's Choice in Recurrent or Persistent Endometrial Cancer Post-Chemotherapy and Immunotherapy

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a treatment for endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study will compare the effects of a medication called sacituzumab govitecan with other treatments chosen by doctors. Sacituzumab govitecan is a type of medicine known as an antibody-drug conjugate, which is designed to target and kill cancer cells. The other treatments that may be used in the study include doxorubicin, a chemotherapy drug, and paclitaxel, another type of chemotherapy that works by stopping cancer cells from dividing.

The purpose of the study is to see how well sacituzumab govitecan works compared to the other treatments in terms of slowing down the progression of the cancer and improving overall survival. Participants in the study will be randomly assigned to receive either sacituzumab govitecan or one of the other treatments. The study will involve regular visits to the clinic for treatment and monitoring, which will include tests like computed tomography (CT) or magnetic resonance imaging (MRI) to check the status of the cancer.

The study will continue for several years, with participants being closely monitored for any changes in their condition and any side effects from the treatments. The goal is to gather information that could help improve treatment options for people with endometrial cancer in the future.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Assignment to a treatment group

    After joining the study, a random assignment occurs. this means a process similar to flipping a coin is used to decide which treatment is received. one of two options is selected: the test medication or the physician's choice of treatment.

  2. Step 2

    Administration of test medication

    If assigned to the test group, sacituzumab govitecan is administered. this medication is given as an intravenous infusion, which means it is delivered directly into a vein through a tube.

  3. Step 3

    Administration of comparator medications

    If assigned to the group receiving the physician's choice, paclitaxel or doxorubicin is administered. both of these medications are also given as an intravenous infusion into the vein.

  4. Step 4

    Monitoring and evaluation

    During the trial, the progress of the endometrial cancer is monitored. effectiveness is measured by tracking progression-free survival, which is the length of time during and after treatment that the cancer does not get worse, and overall survival, which is the total length of time from the start of the study until death from any cause.

Who can join the trial?

12 criteria

  • You must be willing and able to follow all the rules and requirements of the study.
  • You must be assigned female at birth and be of childbearing potential, which means you are still able to have children; if you have sex with a male partner, you must agree to use specific birth control methods.
  • You must have an expected life expectancy, or the amount of time you are expected to live, of at least 3 months.
  • You must be 18 years of age or older, or the minimum age required in your country.
  • You must be able to understand the study and provide written informed consent, which is a signed document showing you agree to participate after being fully informed.
  • You must have medical proof of recurrent or persistent endometrial cancer, which means the cancer has returned or has not gone away.
  • You must have received up to 3 previous lines of systemic therapy, which refers to different types of medical treatments, such as drugs, used to treat cancer throughout the entire body.
  • You must be able to safely receive certain medications called doxorubicin or paclitaxel, as determined by your doctor.
  • Your cancer must be visible on imaging tests like a computed tomography (CT) scan or magnetic resonance imaging (MRI), which are special pictures taken of the inside of your body.
  • There must be proof that your cancer has progressed, meaning the cancer has grown or spread, based on your imaging tests.
  • You must have available tumor tissue from a previous sample or a new biopsy, which is a procedure to remove a small piece of tissue for testing, to check for specific markers called Trop-2 and other biomarkers.
  • You must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, which is a scale used by doctors to measure how well you can perform daily activities and your overall level of physical functioning.

Who cannot join the trial?

24 criteria

  • You are currently receiving other systemic anticancer therapies, which are medicines used throughout the entire body to treat cancer, other than the medicine being studied.
  • You have an active infection of Hepatitis B or Hepatitis C, which are viruses that affect the liver. This includes having a detectable amount of the virus in your blood.
  • You have uterine leiomyosarcoma or endometrial stromal sarcomas, which are specific, rare types of cancer that start in the uterus.
  • You have a scheduled surgery planned during the study, unless it is a minor procedure that will not delay your treatment.
  • You have had active chronic inflammatory bowel disease, such as ulcerative colitis or Crohn’s disease (long-term swelling and irritation in the digestive tract), or a gastrointestinal perforation (a hole in the stomach or intestines) within the last 6 months.
  • You are pregnant, plan to become pregnant, or plan to breastfeed during the study and for one month after your last dose of the study medicine.
  • You have used a live vaccine (a vaccine that uses a weakened form of a germ) within the last 30 days.
  • You have other medical or psychiatric conditions (mental health conditions) that the doctor believes might make it difficult to understand the study results or complete the study requirements.
  • You have any medical condition that the doctor or the study sponsor believes makes participating in the study too risky for you.
  • You are currently a candidate for curative-intent therapy, which means a treatment specifically intended to completely get rid of your cancer.
  • You are eligible to try platinum-based chemotherapy again, which is a type of cancer treatment that uses platinum to kill cancer cells.
  • You have a known or severe hypersensitivity (an extreme allergic reaction) to the study medicine, the other medicines used in the study, or any of the ingredients used to make them.
  • You have previously received treatment with a Trop-2-directed ADC, which is a specific type of targeted drug that delivers medicine directly to cancer cells.
  • You have previously taken any medicine that targets an enzyme called topoisomerase I.
  • You have used anticancer biologic agents (medicines made from living organisms) within 4 weeks, or other treatments like chemotherapy, hormonal therapy, or radiation therapy within 2 weeks of starting the study.
  • You are using other investigational drugs (medicines that are still being tested and are not yet available to the public) within 28 days of starting the study.
  • You have not yet recovered from adverse events (side effects or medical problems) caused by a previous treatment. Note that mild nerve tingling or hair loss are exceptions.
  • You are required to take any prohibited medications that are specifically listed as not allowed for this study.
  • You have active central nervous system metastases (cancer that has spread to the brain or spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
  • You have a second, active malignancy (another type of cancer), unless it was completely treated at least 3 years ago or was a low-risk type like certain skin cancers.
  • Your left ventricular ejection fraction is less than 50%, which is a measurement of how much blood your heart pumps out with each beat.
  • You have a history of significant cardiovascular disease (heart problems), such as a myocardial infarction (heart attack), unstable chest pain, serious irregular heartbeats, or congestive heart failure.
  • You have an active, serious infection that requires systemic antimicrobial therapy (medicine like antibiotics used to fight an infection throughout the body).
  • You have a known history of HIV-1 or 2 with a detectable amount of the virus in your blood.
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Investigated drugs

  • Sacituzumab govitecan

    is the experimental drug being tested in this study. It is a type of therapy designed to target and kill cancer cells in people with endometrial cancer.

  • Paclitaxel

    is a chemotherapy medication used as a comparison treatment to see how effective it is compared to the experimental drug.

  • Doxorubicin

    is a chemotherapy medication used as a comparison treatment to see how effective it is compared to the experimental drug.

What is already known about the treatment

  • Paclitaxel

    This medication is administered as an intravenous injection into a vein to treat various types of cancer. It is a well-established drug in medical practice that works by stopping cancer cells from dividing and growing. As a chemotherapy agent, it attaches to specific proteins within the cell to freeze the cell's internal structure, eventually causing the cancer cell to die.

  • Sacituzumab govitecan

    This is a targeted therapy delivered through an intravenous infusion to treat advanced cancers such as endometrial cancer. It is a newer type of medication that uses an antibody to find specific markers on the surface of cancer cells and then delivers a powerful cell-killing drug directly into them. This process allows the medicine to attack the tumor more precisely while aiming to limit damage to healthy cells.

  • Doxorubicin hydrochloride

    This medication is given through an intravenous infusion to help treat many different types of cancer. It is a commonly used chemotherapy drug that works by interfering with the DNA inside cancer cells, which prevents them from multiplying. By damaging the genetic material needed for cell growth, it helps stop the cancer from spreading throughout the body.

Investigated diseases

Recurrent or Persistent Endometrial Cancer - This condition occurs when cancer cells in the lining of the uterus return after a period of being undetectable. It can also happen if the cancer cells do not fully disappear following initial treatment. The disease involves the uncontrolled growth of abnormal cells within the uterine lining. These cells may continue to multiply and spread within the pelvic region or to other parts of the body. The progression is marked by the regrowth or continued presence of these malignant cells.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511957-23-00Protocol codeGS-US-682-6769Estimated enrolment620 patientsSponsorGilead Sciences Inc.

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