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Study of Pembrolizumab, MK-4830, and Chemotherapy for Patients with High-Grade Serous Ovarian Cancer

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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 treatments for High-Grade Serous Ovarian Cancer, as well as related conditions like Primary Peritoneal Cancer and Fallopian Tube Cancer. The study is testing a combination of medications to see how effective they are in treating these cancers. The main medications being studied are Pembrolizumab (also known as Keytruda), MK-4830, Carboplatin, Paclitaxel, Bevacizumab, and Docetaxel. These medications are given as solutions through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to evaluate whether adding MK-4830 to the standard treatment of Pembrolizumab and chemotherapy can lead to a greater reduction in cancer-related DNA in the blood. Participants will receive these treatments over a period of time, with some receiving a placebo instead of MK-4830. The study will monitor changes in the levels of cancer-related DNA in the blood, as well as the overall response to the treatment, including any side effects experienced by participants.

Throughout the study, participants will undergo regular assessments to track their response to the treatment. This includes measuring changes in cancer-related DNA and evaluating the effectiveness of the treatment in reducing cancer cells. The study aims to provide valuable information on whether the addition of MK-4830 can improve outcomes for patients with these types of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be informed about the trial's purpose and procedures. You will be asked to provide consent to participate.

    You will undergo initial assessments to confirm eligibility, including a review of your medical history and a physical examination.

  2. Step 2

    Initial treatment phase

    You will begin treatment with a combination of medications administered through an intravenous infusion. This includes carboplatin, paclitaxel, and pembrolizumab. The specific dosages and frequency will be determined by the study team.

    The treatment will be given in cycles, with each cycle lasting a few weeks. You will receive the infusions at a healthcare facility.

  3. Step 3

    Additional treatment with mk-4830

    Depending on the study group you are assigned to, you may receive an additional medication called MK-4830 through intravenous infusion.

    This medication will be administered alongside the standard treatment regimen.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, you will have regular appointments to monitor your health and response to the treatment. This includes blood tests and imaging studies.

    The study team will evaluate changes in circulating tumor DNA (ctDNA) to assess the treatment's effectiveness.

  5. Step 5

    Surgery

    If you are a candidate, you may undergo interval debulking surgery. This procedure aims to remove as much of the tumor as possible.

    The timing and specifics of the surgery will be discussed with you by the study team.

  6. Step 6

    Follow-up treatment

    After surgery, you will continue to receive chemotherapy and possibly other medications as part of the study protocol.

    The treatment will continue for a specified duration, with regular monitoring to track your progress.

  7. Step 7

    Completion and final assessments

    Upon completing the treatment phase, you will undergo final assessments to evaluate the overall response to the therapy.

    The study team will discuss the results with you and provide guidance on any further steps or follow-up care needed.

Who can join the trial?

6 criteria

  • The patient must have a confirmed diagnosis of **Stage III or Stage IV** high-grade serous ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. These are advanced stages of certain types of cancer affecting the ovaries, the lining of the abdomen, or the fallopian tubes.
  • The patient must be a candidate for **carboplatin and paclitaxel chemotherapy**. This means the patient should be able to receive these specific cancer-fighting drugs before and after surgery.
  • The patient must be a candidate for **interval debulking surgery**, which is a surgery to remove as much of the tumor as possible after some initial treatment.
  • The patient must be able to provide a sample of the tumor tissue, either from a previous biopsy or a new one. A biopsy is a procedure where a small piece of tissue is taken from the body to be examined.
  • The patient must have **adequate organ functions**, meaning their vital organs like the liver, kidneys, and heart are working well enough to handle the treatment.
  • The patient must be **female**.

Who cannot join the trial?

4 criteria

  • Patients with a history of other types of cancer that are not **primary peritoneal cancer** or **fallopian tube cancer** cannot participate.
  • Only **female** patients are eligible for this study.
  • Patients who are considered part of a **vulnerable population** may not be eligible. This means people who might need special protection or care, like those with certain disabilities or conditions.
  • Patients who are not within the specified **age range** for the study cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used to help treat high-grade serous ovarian cancer by boosting the body's natural defenses against the cancer.

  • MK-4830

    is an experimental medication being studied to see if it can enhance the effects of pembrolizumab and chemotherapy. It is thought to work by targeting specific pathways in the immune system to help it fight cancer more effectively. In this trial, MK-4830 is being tested to see if it can improve treatment outcomes for patients with high-grade serous ovarian cancer when used alongside pembrolizumab and standard chemotherapy.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently well-established in medical literature as an immunotherapy drug used to treat various types of cancer. The main therapeutic indications for pembrolizumab include its use in treating high-grade serous ovarian cancer, among others. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as a monoclonal antibody in pharmacology.

  • MK-4830

    MK-4830 is also administered intravenously, similar to pembrolizumab, and is currently being studied in clinical trials for its potential use in cancer treatment. It is being investigated for its effectiveness in treating high-grade serous ovarian cancer when used in combination with pembrolizumab and standard chemotherapy. MK-4830 works by targeting specific pathways that may help enhance the immune system's ability to fight cancer. It is classified as an investigational immunotherapy agent.

Investigated diseases

  • Primary peritoneal cancer

    This cancer originates in the peritoneum, a thin layer of tissue lining the abdomen. It shares similarities with ovarian cancer in terms of symptoms and progression. The disease often begins with the abnormal growth of cells in the peritoneum, which can spread to other abdominal organs. As it progresses, it may cause abdominal swelling, pain, and digestive issues. The cancer cells can spread through the peritoneal cavity, leading to further complications. It is often diagnosed at an advanced stage due to its subtle early symptoms.

  • Fallopian tube cancer

    This rare type of cancer starts in the fallopian tubes, which connect the ovaries to the uterus. It typically begins with the uncontrolled growth of cells in the lining of the fallopian tubes. As the disease progresses, it can cause symptoms such as pelvic pain, abnormal vaginal bleeding, and a palpable mass. The cancer may spread to nearby organs and tissues, including the ovaries and peritoneum. It often remains undetected until it has advanced, due to its nonspecific symptoms. The progression can lead to complications in the reproductive and abdominal areas.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505005-16-00Protocol codeMK-4830-002Estimated enrolment98 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).