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Study of Chemotherapy With Pembrolizumab and Olaparib for Patients With Advanced Epithelial Ovarian Cancer Without BRCA Mutation

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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 advanced epithelial ovarian cancer, a type of cancer that affects the ovaries. The study involves several medications, including pembrolizumab (also known as Keytruda), olaparib, paclitaxel, bevacizumab, docetaxel, and carboplatin. Some participants will receive a placebo instead of the active medications. The purpose of the study is to compare the effectiveness of these treatments in preventing the cancer from getting worse.

Participants in the study will receive chemotherapy with or without pembrolizumab, followed by maintenance treatment with olaparib or a placebo. The study will be conducted over a period of time, with regular monitoring to assess the progression of the disease. The treatments will be administered through intravenous infusions or oral tablets, depending on the specific medication.

The study aims to provide valuable information on how these treatments can help manage advanced epithelial ovarian cancer, particularly in patients without BRCA mutations. The results will help determine the best treatment options for improving the quality of life and survival rates for individuals with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    Upon joining the study, the initial treatment phase begins. This involves receiving a combination of chemotherapy drugs, including paclitaxel and carboplatin. These medications are administered through an intravenous infusion, which means they are given directly into a vein.

    The treatment is typically given in cycles, with each cycle lasting about three weeks. The exact number of cycles will depend on the specific treatment plan designed for the study.

  2. Step 2

    Additional medication

    In addition to chemotherapy, the study includes the administration of pembrolizumab, which is also given through an intravenous infusion. This medication is designed to help the immune system fight cancer cells.

    The frequency and duration of pembrolizumab administration will be determined by the study protocol and may vary based on individual response and tolerance.

  3. Step 3

    Maintenance phase

    Following the initial treatment phase, the study enters a maintenance phase. During this phase, participants may receive olaparib in the form of film-coated tablets taken orally.

    The maintenance phase aims to help prevent the cancer from returning and is expected to continue for a specified period, as outlined in the study protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, regular monitoring and follow-up appointments are scheduled. These appointments are essential for assessing the response to treatment and managing any side effects.

    Participants will undergo various tests and evaluations, including imaging studies and laboratory tests, to track the progress of the treatment and ensure safety.

  5. Step 5

    End of study participation

    At the conclusion of the study, participants will have a final evaluation to assess the overall outcomes of the treatment.

    Further recommendations for ongoing care and follow-up will be provided based on the results of the study and individual health needs.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of advanced epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. This includes specific types like high-grade serous, endometrioid, carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or low-grade serous ovarian cancer.
  • The patient must have just completed or be eligible for primary debulking surgery, or be a potential candidate for interval debulking surgery. Debulking surgery is a procedure to remove as much of the tumor as possible.
  • The patient must be a candidate for chemotherapy with carboplatin and paclitaxel, which can be given before or after surgery.
  • If the patient is a candidate for chemotherapy before surgery, they must have a specific ratio of cancer markers in their blood, with a CA-125:CEA ratio of 25 or higher. CA-125 and CEA are substances in the blood that can be higher in some cancer patients.
  • The patient must be able to provide a new sample of their tumor for testing specific genetic markers, such as BRCA1/2 and PD-L1, before starting the study. These markers can help understand the cancer better.
  • The patient must have a good general health status, with an ECOG performance status of 0 or 1. This is a scale used to assess how the disease affects daily living abilities, where 0 means fully active and 1 means some symptoms but nearly fully active.
  • The patient must be female and not pregnant or breastfeeding. If the patient is of childbearing potential, they must use a highly effective method of birth control or abstain from heterosexual intercourse during the study and for a specified period after the last dose of study medication. A negative pregnancy test is required before starting the study.
  • The patient must have adequate organ function, meaning their vital organs like the liver and kidneys are working well enough to participate in the study.

Who cannot join the trial?

3 criteria

  • Patients who do not have advanced epithelial ovarian cancer cannot participate. This is a type of cancer that affects the surface layer of the ovaries.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are considered part of a vulnerable population are excluded. This means groups of people who might be at higher risk or need special protection in a study.
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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, it is being used to see if it can help treat advanced epithelial ovarian cancer when combined with chemotherapy.

  • Olaparib

    is a medication that belongs to a group of drugs called PARP inhibitors. It works by blocking a protein that cancer cells need to repair themselves, which can help stop the cancer from growing. In this study, it is being used as a maintenance treatment to see if it can help keep the cancer from coming back after initial treatment with chemotherapy and pembrolizumab.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced epithelial ovarian cancer, particularly in cases where the cancer does not have BRCA mutations. Pembrolizumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein called PD-1 on immune cells, which can otherwise prevent them from attacking cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system fight cancer.

  • Olaparib

    Olaparib is taken orally in the form of tablets or capsules. It is being investigated in clinical trials for its potential to maintain the effects of chemotherapy in treating advanced epithelial ovarian cancer without BRCA mutations. Olaparib works by inhibiting a protein called PARP, which helps repair damaged DNA in cells. By blocking PARP, olaparib makes it harder for cancer cells to repair themselves, leading to their death. It is classified as a PARP inhibitor, a type of targeted cancer therapy.

Investigated diseases

Advanced epithelial ovarian cancer – This disease is a type of cancer that originates in the epithelial cells lining the ovaries. It is characterized by the abnormal growth of cells that can invade nearby tissues and spread to other parts of the body. The progression of this cancer often involves the spread to the abdominal cavity and other organs, such as the liver and lungs. As the disease advances, it can cause symptoms like abdominal bloating, pelvic pain, and changes in bowel habits. The cancer cells can form tumors that may lead to fluid accumulation in the abdomen, known as ascites. Over time, the disease can become more aggressive and challenging to manage.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502124-52-00Protocol codeMK-7339-001Estimated enrolment1 366 patientsSponsorMerck Sharp & Dohme LLC

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