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A study of sacituzumab tirumotecan and bevacizumab in patients with newly diagnosed advanced ovarian cancer following first-line platinum-based chemotherapy

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What is this trial about?

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

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.

The research process

The trial runs in 1 step.

  1. Step 1

    Maintenance treatment administration

    The maintenance treatment phase begins after completing the first line of platinum-based chemotherapy. this phase involves receiving one of two different treatment options.

    The first option is the administration of sacituzumab tirumotecan (mk-2870), which is given as an intravenous infusion (a liquid medicine delivered through a vein) at a dose of 4 mg/kg (milligrams per kilogram of body weight).

    The second option involves receiving sacituzumab tirumotecan at 4 mg/kg combined with bevacizumab (either avastin or mvasi). the bevacizumab is administered via intravenous infusion at a dose of 15 mg/kg.

Who can join the trial?

10 criteria

  • 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 trial?

13 criteria

  • 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.
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Investigated drugs

  • 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.

What is already known about the treatment

  • Sacituzumab tirumotecan

    This medication is an injectable solution administered through an intravenous infusion to treat certain types of cancer. It is an advanced targeted therapy that works by attaching itself to specific proteins found on the surface of cancer cells to deliver a powerful cell-killing drug directly into the tumor. This approach allows the medication to attack cancer cells more precisely while aiming to minimize damage to healthy tissues. It is currently used in clinical research and medical practice as a specialized cancer treatment.

  • Bevacizumab

    This medication is provided as a solution for infusion and is administered directly into a vein. It belongs to a class of drugs called angiogenesis inhibitors, which work by blocking a specific protein that helps tumors grow new blood vessels. By preventing the formation of these blood vessels, the drug effectively starves the tumor of the nutrients and oxygen it needs to expand. It is a well-established treatment used in various medical settings to manage different types of cancer.

Investigated diseases

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.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508047-40-00Protocol codeMK-2870-021Estimated enrolment946 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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