A study comparing Rinatabart Sesutecan to other treatments in patients with endometrial cancer who have previously received platinum-based chemotherapy and PD-L1 therapy
This study is being conducted to compare the effectiveness and safety of a new drug called rinatabart sesutecan against other treatments chosen by a doctor. The research focuses on individuals with endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This study specifically involves patients whose cancer is advanced, has returned after previous treatment, or has spread to other parts of the body. The participants in this trial have previously received platinum-based chemotherapy and PD(L)-1 therapy, which are types of treatments used to kill cancer cells or help the immune system fight the disease.
In this study, participants will receive either rinatabart sesutecan or a treatment selected by their doctor, which may include medications such as doxorubicin or paclitaxel. These medications are administered through an IV infusion, a method where medicine is delivered directly into a vein through a small tube. The study aims to determine if the new drug works better than the standard options currently available for this condition.
During the course of the study, participants will undergo regular monitoring to track how the cancer responds to the medication and to observe any side effects. The researchers will look at how long the cancer remains stable without growing and the overall survival of the participants. This process involves continuous observation over several years to collect data on how the treatments affect the health and well-being of the individuals involved.
Who Can Join the Study?
You must be female.
You must have endometrial cancer (cancer of the lining of the uterus) that has returned or is getting worse after previous treatment.
The cancer must be a specific type, meaning it cannot be neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma (these are specific, different types of cancer cells).
The cancer must have been confirmed through a histology or cytology test (tests where a doctor looks at cells under a microscope to confirm the disease).
You must have had between 1 and 3 previous treatments for your cancer.
You must have previously received platinum-based chemotherapy (a type of cancer medicine that uses platinum) and a PD(L)-1 inhibitor (a type of immunotherapy, which is a drug that helps your immune system fight cancer).
If your cancer returned more than 12 months after your last platinum-based chemotherapy, you must receive more of this treatment unless it is not possible for you to have it.
If you are starting immunotherapy (treatment that uses the body’s immune system) for the returning cancer, you do not have to receive more platinum-based chemotherapy.
Your cancer must have shown growth or spreading on radiographic imaging (pictures of the inside of your body, such as a CT scan or MRI) since your last treatment.
Who Cannot Join the Study?
You have previously received treatment using an antibody-drug conjugate (a type of medicine that uses an antibody to deliver a drug directly to cancer cells) that contains a topoisomerase 1 inhibitor (a substance that stops cancer cells from multiplying).
You have a current or past malignancy (cancer) other than the specific type of cancer being studied, or you have signs that a previous cancer is still present in your body. Certain minor cancers that are unlikely to spread or cause death, such as some skin cancers or cancers that were cured more than 3 years ago, may be allowed.
You have active cancer that has spread to your central nervous system (the brain and spinal cord) or have carcinomatous meningitis (a condition where cancer cells spread to the membranes covering the brain and spinal cord). People with treated brain cancer may join if they have been stable for 4 weeks and are not taking specific medications for brain symptoms.
You have had a gastrointestinal obstruction (a blockage in your stomach or intestines) that required hospital care or caused symptoms within the last 91 days.
You show signs of a blockage in your stomach or intestines on medical imaging tests during your screening.
You currently require parenteral nutrition (nutrients delivered directly into your veins rather than through eating).
Rinatabart sesutecan is the experimental treatment being tested in this study to see how well it works against endometrial cancer.
Doxorubicin is a type of chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.
Paclitaxel is another chemotherapy drug used as a comparison treatment to help evaluate the effectiveness of the study drug.
Endometrial cancer – This disease occurs when abnormal cells begin to grow in the lining of the uterus. These cells can multiply uncontrollably and form a mass. The condition can start in one specific area or spread to other parts of the uterine lining. It may also progress to involve nearby tissues or move to distant parts of the body. Over time, the abnormal growth can continue to expand and change the structure of the uterine environment.
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