A study of sacituzumab tirumotecan and bevacizumab in patients with newly diagnosed advanced ovarian cancer following first-line platinum-based chemotherapy
This study focuses on individuals with newly diagnosed advanced Ovarian Cancer that is HRD-negative, which means the cancer cells have a specific type of genetic profile related to how they repair their DNA. The purpose of this study is to compare a maintenance treatment using MK-2870, also known as sacituzumab tirumotecan, either alone or combined with bevacizumab, against the current standard medical care. Maintenance treatment refers to therapy given to keep the cancer from growing again after the initial main treatment has finished.
Participants in the study will receive medications through an intravenous infusion, which is a method of delivering medicine directly into a vein. The study involves comparing different combinations of drugs to see how they affect progression-free survival, a term used to describe the length of time during and after treatment that a person lives with the disease without it getting worse. Other factors being observed include overall survival and the quality of life, which tracks how well a person can perform daily activities and their general well-being during the study.
Who Can Join the Study?
Must be a female patient.
Must be between the ages of 12 and 17 years old.
Must have a confirmed diagnosis of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer that is at Stage III or Stage IV, which means the cancer has grown or spread significantly.
Must have finished a debulking surgery, which is a procedure to remove as much of the tumor as possible from the body.
Must have completed their first round of platinum-based chemotherapy, which is a type of medicine used to kill cancer cells.
The cancer must have shown a stable disease (meaning it did not grow), a partial response (meaning the tumor shrank), or a complete response (meaning no cancer was found) after the first treatment.
Must be able to provide a tumor tissue sample that has not been treated with radiation (high-energy beams used to kill cancer cells).
If the patient has HIV (a virus that affects the immune system), it must be well-controlled using antiretroviral therapy (medicines used to manage the virus).
If the patient has Hepatitis B (a virus that affects the liver), the viral load (the amount of virus in the blood) must be undetectable, and they must be taking antiviral therapy (medicine to fight the virus).
If the patient has a history of Hepatitis C (another virus that affects the liver), the viral load must be undetectable.
Who Cannot Join the Study?
Having types of cancer other than the specific ovarian cancer being studied, such as nonepithelial cancers, borderline tumors (growths that are not fully cancerous), mucinous tumors (tumors that produce mucus), malignant Brenner’s tumors, or undifferentiated carcinoma (cancer cells that do not look like normal cells).
Having an active infection (a current illness caused by germs) that requires systemic therapy (medicine that travels through the entire body).
Having current infections of the Hepatitis B virus (HBV) or Hepatitis C virus (HCV), which are viruses that affect the liver.
Having an HIV infection or a history of Kaposi’s sarcoma or multicentric Castleman’s disease (types of rare cancers or disorders affecting the immune system).
Not having fully recovered from a major surgery or having ongoing problems caused by a recent surgery.
Having active central nervous system (CNS) metastases (cancer that has spread to the brain or spine) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
Having a history of severe eye disease.
Having active inflammatory bowel disease (a condition causing swelling in the digestive tract) that requires immunosuppressive medication (drugs that lower the body’s immune response) or having had this disease in the past.
Having uncontrolled cardiovascular disease (serious heart problems) or cerebrovascular disease (problems with blood flow to the brain, such as a stroke).
Having a history of, or currently having, pneumonitis (inflammation of the lung tissue) or interstitial lung disease (ILD) (a group of disorders that cause scarring of lung tissue) that required the use of steroids (strong anti-inflammatory medicines).
Having received prior systemic anticancer therapy (previous treatments like chemotherapy that travel through the bloodstream to fight cancer).
Having received a live or live-attenuated vaccine (a vaccine containing a weakened form of a germ) within 30 days before being assigned to the study groups.
Having another type of malignancy (cancer) that is growing or required active treatment within the last 3 years.
Sacituzumab tirumotecan is a medication administered through an intravenous infusion. It is being studied as a maintenance treatment to help manage advanced ovarian cancer after a patient has completed their first round of platinum-based chemotherapy.
Bevacizumab is a medication given through an intravenous infusion. In this study, it is used either alongside sacituzumab tirumotecan or as part of the standard care to help treat advanced ovarian cancer.
Ovarian cancer – This disease occurs when harmful cells grow uncontrollably in the ovaries. These cells can form masses or tumors that disrupt normal organ function. The condition often begins in the surface cells of the ovary and can spread to nearby tissues or other parts of the body. As the disease progresses, the abnormal cells may move through the pelvic area or the abdominal cavity. This spreading process can lead to various changes in how the reproductive system and surrounding organs operate.
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