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A Study of Sacituzumab Tirumotecan, Pembrolizumab, and Bevacizumab for Patients with Metastatic Cervical Cancer That Has Spread or Returned

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What is this trial about?

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

This study is looking at cervical cancer that has spread to other parts of the body, has come back after previous treatment, or continues to grow despite treatment. The study is for people whose cancer cannot be cured with surgery or radiation therapy. The cancer cells must also show a certain level of a protein marker called PD-L1 with a score of 1 or higher. The study will test several medications including sacituzumab tirumotecan (also known as MK-2870), pembrolizumab, and bevacizumab. Other treatments that may be used in the study include cisplatin, carboplatin, and paclitaxel. These medications will be given through a vein as infusions.

The purpose of the study is to compare different combinations of these medications to see which treatment works better at keeping the cancer from getting worse and helping people live longer. The study will also look at how safe these treatments are and how they affect quality of life. The study has two parts. The first part is a safety check with a small number of people to make sure the combination of sacituzumab tirumotecan, pembrolizumab, and bevacizumab is safe to use together. The second part will compare different treatment combinations to standard treatments.

Participants will receive their assigned treatment as maintenance therapy, which means treatment given after initial therapy to help keep the cancer under control. During the study, doctors will regularly check how the cancer is responding to treatment using imaging scans and will monitor for any side effects. Participants will also be asked questions about their daily activities and how they are feeling to understand how the treatment affects their quality of life. The study will track whether the cancer grows or spreads and how long participants live.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    This clinical trial consists of two parts. The first part is a safety evaluation phase, and the second part is the maintenance treatment phase.

    Before entering the maintenance phase, you will receive initial treatment for your cervical cancer. The type of initial treatment will be determined based on the treatment group assigned to you.

    The initial treatment may include combinations of chemotherapy (medications that kill cancer cells) and targeted therapy (medications that work against specific cancer characteristics).

  2. Step 2

    Assignment to treatment group

    After completing the initial treatment phase, you will be randomly assigned to one of several treatment groups for maintenance therapy. Random assignment means that neither you nor your doctor will choose which group you are in.

    The possible treatment groups include: sacituzumab tirumotecan (also called MK-2870) combined with pembrolizumab, with or without bevacizumab, or standard care treatment.

    Standard care treatment may include combinations of medications such as paclitaxel, carboplatin, cisplatin, pembrolizumab, and bevacizumab.

  3. Step 3

    Maintenance treatment administration

    All medications in this trial are given through intravenous infusion, which means they are delivered directly into a vein over a period of time.

    The treatment will be given in cycles. Each cycle typically lasts a specific number of weeks, and the medications are administered on certain days within each cycle.

    The exact dosage, frequency, and duration of each medication will depend on the treatment group assigned to you and will be determined by the study protocol.

    You will continue receiving maintenance treatment for as long as the treatment is working and you are not experiencing unacceptable side effects.

  4. Step 4

    Regular monitoring visits

    Throughout the trial, you will have regular visits to the study site for monitoring and assessment.

    During these visits, your health status will be evaluated, and any side effects or adverse events will be recorded.

    Medical examinations and tests will be performed to assess how well the treatment is working and to monitor your overall health.

    Your quality of life will be assessed using questionnaires that ask about your physical functioning, daily activities, and overall well-being.

  5. Step 5

    Imaging and disease assessment

    Periodic imaging scans will be performed to evaluate the status of your cancer and determine if the disease is progressing, staying stable, or improving.

    These assessments will be conducted according to established criteria called Response Evaluation Criteria in Solid Tumors Version 1.1, which is a standardized way to measure changes in tumors.

    The scans will be reviewed both by your treating doctor and by independent reviewers who are not involved in your direct care.

  6. Step 6

    Ongoing safety monitoring

    Your safety will be continuously monitored throughout the trial. Any side effects or health changes will be documented and assessed.

    If you experience side effects that are unacceptable or if your cancer progresses despite treatment, adjustments to your treatment may be made, or treatment may be discontinued.

    Blood tests and other laboratory assessments will be performed regularly to monitor how your body is responding to the medications.

  7. Step 7

    End of treatment

    Treatment will continue until your cancer progresses, you experience unacceptable side effects, you decide to withdraw from the study, or your doctor determines it is no longer beneficial to continue.

    When you stop receiving study treatment, a final assessment will be conducted to evaluate your overall health status.

  8. Step 8

    Follow-up period

    After you stop receiving treatment, you will enter a follow-up period during which your health will continue to be monitored.

    Follow-up visits or contacts may occur at specified intervals to assess your long-term health outcomes and survival.

    The trial is expected to continue until 2033, which includes both the treatment and follow-up phases for all participants.

Who can join the trial?

8 criteria

  • You must have a confirmed diagnosis through tissue examination of squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix. These are different types of cervical cancer identified by looking at cells under a microscope.
  • You must have cervical cancer that has come back after treatment, has continued despite treatment, or has been newly found to have spread to other parts of the body, and cannot be cured with surgery or radiation therapy.
  • If you have HIV (a virus that affects the immune system), your condition must be well controlled with medications called antiretroviral therapy.
  • If you test positive for hepatitis B surface antigen (a marker showing hepatitis B infection in your blood), you must be receiving treatment for hepatitis B virus and the virus must not be detectable in your blood tests.
  • If you have had hepatitis C virus infection in the past (a virus that affects the liver), the virus must not be detectable in your blood tests.
  • You must have an Eastern Cooperative Oncology Group performance status of 0 or 1. This is a scale that measures how well you can perform daily activities, where 0 means you are fully active and 1 means you have some restrictions but can still do light work.
  • Your tumor must have a PD-L1 expression with a combined positive score of 1 or higher. This is a laboratory test that measures a specific protein on cancer cells, which helps predict if certain treatments may work for you.
  • You must be an adult woman, as this study only includes female participants.

Who cannot join the trial?

4 criteria

  • The study is only for female patients. Male patients cannot participate in this study.
  • Patients who are children or teenagers under 18 years old cannot participate in this study.
  • Patients with cervical cancer that has spread to other parts of the body (metastatic cervical cancer) must have a specific test result called PD-L1 CPS (a measure of a protein on cancer cells) that is 1 or higher. If this number is less than 1, the patient cannot participate.
  • The cancer must be persistent (did not go away with treatment), recurrent (came back after treatment), or newly diagnosed (recently found for the first time). Other types or stages of cervical cancer may not be eligible.
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Investigated drugs

Sacituzumab Tirumotecan (also called MK-2870) is an investigational medication being tested as a maintenance treatment for cervical cancer. It is designed to target and attack cancer cells in people whose cancer has spread or come back after previous treatment.

Pembrolizumab is an immunotherapy medication that helps your immune system recognize and fight cancer cells. It works by blocking a protein that prevents immune cells from attacking the cancer, allowing your body's natural defenses to work better against the disease.

Bevacizumab is a medication that works by blocking the growth of new blood vessels that tumors need to grow and spread. By limiting the blood supply to cancer cells, it can help slow down or stop tumor growth.

Standard of Care refers to the usual treatment approach that doctors currently use for this type of cancer. This serves as the comparison treatment in the study to see if the investigational medications work better.

What is already known about the treatment

  • Sacituzumab Tirumotecan

    This medication is given through an intravenous infusion (directly into a vein) and is currently being studied in clinical trials for treating cervical cancer that has spread or come back. It is designed to work as a targeted therapy that delivers a cancer-killing drug specifically to cancer cells by attaching to a protein found on their surface. Sacituzumab Tirumotecan belongs to a class of drugs called antibody-drug conjugates, which combine an antibody that finds cancer cells with a chemotherapy drug that destroys them once delivered to the target.

  • Pembrolizumab

    This medication is administered as an intravenous infusion and is an approved immunotherapy drug widely used in cancer treatment, including cervical cancer. It works by blocking a protein called PD-1 on immune cells, which allows the body's immune system to recognize and attack cancer cells more effectively. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system fight cancer by removing the brakes that prevent it from attacking tumors.

  • Bevacizumab

    This medication is given through an intravenous infusion and is an established cancer treatment approved for various types of cancer, including cervical cancer. It works by blocking a protein called VEGF that tumors use to grow new blood vessels, effectively starving the tumor of the nutrients and oxygen it needs to grow and spread. Bevacizumab belongs to a class of medications called angiogenesis inhibitors, which prevent the formation of new blood vessels that feed cancer cells.

Investigated diseases

Metastatic Cervical Cancer – Metastatic cervical cancer is an advanced stage of cervical cancer where the disease has spread beyond the cervix to distant parts of the body. The cancer originates in the cervix, which is the lower part of the uterus that connects to the vagina. As the disease progresses, cancer cells break away from the original tumor and travel through the lymphatic system or bloodstream to other organs. Common sites where cervical cancer may spread include the lungs, liver, bones, and distant lymph nodes. The cancer can be persistent, meaning it continues despite treatment, recurrent, meaning it returns after a period of remission, or newly diagnosed at an advanced stage. This condition represents a progression from earlier stages of cervical cancer where the disease was confined to the cervix or nearby tissues.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521514-26-00Protocol codeMK-2870-036Estimated enrolment1 056 patientsSponsorMerck Sharp & Dohme LLC

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