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Study of Pembrolizumab, Paclitaxel, and Bevacizumab for Patients with Platinum-Resistant Recurrent 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 ovarian cancer, specifically in cases where the cancer has returned and is resistant to platinum-based chemotherapy. The study involves several medications: pembrolizumab, also known by its code name MK-3475, paclitaxel, bevacizumab, and a placebo. The purpose of the study is to compare the effectiveness of these treatments in combination, with or without bevacizumab, in improving the time patients live without the cancer getting worse.

Participants in the study will receive treatment through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 24 months, during which time patients will be monitored regularly. The study aims to see how well the treatments work in stopping the cancer from progressing, as well as to observe any side effects and overall survival rates. The study will also assess the impact of the treatments on patients' quality of life, including their general health and any symptoms related to the abdomen and gastrointestinal tract.

This trial is designed to provide valuable information on the potential benefits and risks of using these medications in combination for treating platinum-resistant recurrent ovarian cancer. By comparing different treatment combinations, the study hopes to find more effective ways to manage this challenging condition. Participants will be closely monitored by healthcare professionals throughout the study to ensure their safety and well-being.

The research process

The trial runs in 4 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 randomly assigned to one of the treatment groups. This means you will either receive the study medication or a placebo, which is a substance with no active drug, in combination with other treatments.

  2. Step 2

    Treatment administration

    You will receive the medications through an intravenous infusion, which means the medication will be given directly into your vein. The medications involved in the study include pembrolizumab, paclitaxel, and possibly bevacizumab.

    Pembrolizumab is given as a 25 mg/mL concentrate for solution for infusion. The exact dosage and frequency will be determined by the study protocol.

    Paclitaxel is also administered through intravenous infusion. The dosage and frequency will be specified by the study team.

    If you are in the group receiving bevacizumab, it will also be administered through intravenous infusion. The dosage and frequency will be determined by the study protocol.

  3. Step 3

    Monitoring and assessments

    Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effects of the treatment. This includes physical exams, blood tests, and imaging studies to check the progression of your condition.

    Your overall health status and quality of life will be assessed using specific questionnaires designed to measure these aspects.

  4. Step 4

    End of treatment

    The treatment phase will continue until the study's end date or until you and your doctor decide it is best to stop. This decision will be based on your health and the study's findings.

    After completing the treatment phase, you may have follow-up visits to monitor your health and gather additional information for the study.

Who can join the trial?

10 criteria

  • The patient must have a confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.
  • The patient must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • The patient must have received 1 or 2 previous treatments for ovarian cancer, including at least one treatment with a platinum-based drug. Previous treatments with certain other drugs do not count as separate treatments.
  • The patient must have signed a document agreeing to participate in the study, known as informed consent.
  • The patient must show evidence of the disease getting worse within 6 months after the last dose of platinum-based chemotherapy, which is known as platinum-resistant disease.
  • The patient must be eligible to receive paclitaxel chemotherapy, and bevacizumab if it is being used.
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1, which means they are fully active or have some symptoms but do not need to stay in bed.
  • If the patient is a woman, she must not be pregnant or breastfeeding. If she can have children, she must use a highly effective birth control method.
  • The patient must have disease that can be evaluated by imaging tests, either measurable or non-measurable, as determined by the study doctor.
  • The patient must provide a sample of tumor tissue, either from a previous surgery or a new biopsy, that has not been treated with radiation.

Who cannot join the trial?

3 criteria

  • Patients who have a different type of cancer than ovarian, fallopian tube, or primary peritoneal carcinoma cannot participate.
  • Only female patients are eligible for this study.
  • Patients who are part of a vulnerable population may not be eligible. This means groups of people who might need special protection or care.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. In this trial, pembrolizumab is being tested to see if it can help improve the treatment of ovarian cancer when used with other medications.

  • Paclitaxel

    is a chemotherapy drug that is used to stop the growth of cancer cells. It works by interfering with the way cells divide, which can slow down or stop the spread of cancer. In this study, paclitaxel is used in combination with other treatments to see if it can be more effective against ovarian cancer.

  • Bevacizumab

    is a medication that works by blocking the growth of new blood vessels that tumors need to grow. By cutting off the blood supply, bevacizumab can help slow down the growth of cancer. In this trial, it is used alongside other treatments to see if it can improve outcomes for patients with ovarian cancer.

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 platinum-resistant recurrent ovarian cancer, specifically in combination with other drugs like paclitaxel and bevacizumab. The main therapeutic indication for pembrolizumab in this trial is to improve progression-free survival in patients with ovarian, fallopian tube, or primary peritoneal carcinoma. At the molecular level, pembrolizumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

  • Ovarian carcinoma

    Ovarian carcinoma is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often starts on the surface of the ovary and can spread to other parts of the pelvis and abdomen. The disease progresses through stages, beginning with localized growth and potentially advancing to widespread metastasis. Symptoms may include abdominal bloating, pelvic pain, and changes in bowel habits. As the disease advances, it can lead to fluid accumulation in the abdomen and other systemic symptoms. The progression is typically monitored through imaging and clinical evaluation.

  • Fallopian tube carcinoma

    Fallopian tube carcinoma is a rare cancer that originates in the fallopian tubes, which connect the ovaries to the uterus. It often presents with symptoms such as pelvic pain, abnormal vaginal bleeding, and a pelvic mass. The disease can spread to nearby organs and tissues, including the ovaries and peritoneum. As it progresses, it may cause more generalized symptoms like abdominal swelling and discomfort. The cancer is staged based on its spread, with early stages confined to the tubes and later stages involving distant metastasis. Monitoring involves regular imaging and physical examinations.

  • Primary peritoneal carcinoma

    Primary peritoneal carcinoma is a cancer that arises from the peritoneum, the lining of the abdominal cavity. It shares many similarities with ovarian cancer, including its symptoms and progression. The disease often presents with abdominal pain, bloating, and changes in bowel habits. As it advances, it can lead to fluid buildup in the abdomen and spread to other organs. The progression is categorized into stages, with early stages being localized and later stages involving widespread dissemination. Regular monitoring through imaging and clinical assessments is essential to track its progression.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-506177-35-00Protocol codeMK-3475-B96Estimated enrolment614 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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