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Study of Pembrolizumab for Patients with Recurrent, Platinum-Resistant Ovarian, Fallopian Tube, and Primary Peritoneal Cancer

Verified siteRegistered drugNo placebo
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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 certain types of cancer, specifically ovarian cancer, Fallopian tube cancer, and primary peritoneal cancer. These cancers are described as recurrent, meaning they have returned after treatment, and platinum-resistant, indicating that they do not respond well to platinum-based chemotherapy. The study involves a treatment using a medication called Pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a type of drug that is given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of this study is to evaluate how well Pembrolizumab works in patients with these specific types of cancer. The study will look at how long patients live after receiving the treatment, which is referred to as overall survival. Additionally, the study will monitor other aspects such as the side effects of the treatment, how the cancer responds to the treatment, how long patients live without the cancer getting worse, and the overall quality of life of the patients during the study.

Participants in the study will receive Pembrolizumab as a single treatment over a period of up to 24 months. The study is designed to gather information on the effectiveness and safety of Pembrolizumab in treating these cancers. By participating in this study, researchers hope to gain valuable insights that could help improve treatment options for patients with these challenging types of cancer in the future.

The research process

The trial runs in 6 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, the patient must provide written informed consent. This indicates understanding and agreement to participate in the trial.

    The patient must be at least 18 years old and have a confirmed diagnosis of recurrent, platinum-resistant ovarian, Fallopian tube, or primary peritoneal cancer with a CPS score greater than 1.

  2. Step 2

    Initial assessment

    The patient undergoes an initial assessment to confirm eligibility. This includes a review of medical history and a physical examination.

    A biopsy of a tumor lesion is required, unless it poses a safety concern or is inaccessible. This biopsy must be obtained within six weeks prior to starting treatment.

  3. Step 3

    Treatment initiation

    Treatment begins with the administration of pembrolizumab, also known as KEYTRUDA. This medication is given as a solution for infusion.

    The infusion is administered intravenously, meaning it is delivered directly into a vein.

  4. Step 4

    Treatment schedule

    The patient receives pembrolizumab at a dosage of 25 mg/mL. The frequency and duration of administration are determined by the study protocol and the patient's response to treatment.

  5. Step 5

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to treatment are closely monitored. This includes regular medical evaluations and laboratory tests to assess organ function and overall health.

    The primary goal is to evaluate overall survival, while secondary goals include assessing toxicity, response rate, progression-free survival, and quality of life.

  6. Step 6

    Completion of the trial

    The trial is estimated to conclude by October 28, 2025. Upon completion, the patient's participation in the study ends, and final assessments are conducted to gather data on the treatment's effectiveness and safety.

Who can join the trial?

8 criteria

  • Have **platinum-resistant** ovarian, Fallopian tube, or primary peritoneal cancer. This means the cancer did not respond well to platinum-based chemotherapy, with a return of cancer within 1 to 6 months after the last treatment.
  • Have a **CPS score** greater than 1. CPS stands for Combined Positive Score, which is a way to measure certain proteins in cancer cells.
  • Be willing and able to provide written informed consent or assent for the trial. This means you agree to participate after understanding the study details.
  • Be 18 years of age or older on the day of signing the informed consent.
  • Have measurable disease or disease that can be evaluated based on **RECIST 1.1**. RECIST is a set of guidelines to measure how well a cancer treatment works. Patients with only an increase in **CA 125** (a protein that can be a sign of cancer) without other evidence of disease are not included.
  • Be willing to provide a tissue sample from a newly obtained biopsy of a tumor lesion. A biopsy is a small sample of tissue taken from the body to examine more closely. If a new sample cannot be provided due to safety concerns or inaccessibility, an archived specimen may be submitted.
  • Have a performance status of 0 or 1 on the **ECOG Performance Scale**. This scale measures how well you can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Demonstrate adequate organ function as defined in the study protocol. This means your organs are working well enough to participate in the study, and all necessary lab tests should be done within 10 days before starting treatment.

Who cannot join the trial?

6 criteria

  • Patients who do not have **recurrent** cancer. This means the cancer has come back after treatment.
  • Patients whose cancer is not **platinum-resistant**. This means the cancer does not respond to certain chemotherapy drugs that contain platinum.
  • Patients with a **CPS score** of 1 or less. CPS stands for Combined Positive Score, which is a way to measure certain proteins in cancer cells.
  • Patients who do not have cancer in the **ovaries**, **Fallopian tubes**, or **peritoneum**. The peritoneum is the lining of the abdomen.
  • Patients who are not female, as the study is only for female patients.
  • Patients who are considered part of a **vulnerable population**. This means groups of people who might need special protection or care.
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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to treat patients with certain types of cancer, specifically ovarian, Fallopian tube, and primary peritoneal cancer that are resistant to platinum-based treatments. It works by helping the immune system recognize and attack cancer cells. This trial aims to evaluate how effective Pembrolizumab is in improving the overall survival of patients with these types of cancer.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating recurrent, platinum-resistant ovarian, Fallopian tube, and primary peritoneal cancer in patients with a CPS score greater than 1. The medication works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.

Investigated diseases

  • Ovarian Cancer

    This is a type of cancer that begins in the ovaries, which are the reproductive glands found in women. It often goes undetected until it has spread within the pelvis and abdomen. In its early stages, it may not cause noticeable symptoms, but as it progresses, it can lead to abdominal bloating, pelvic pain, and changes in bowel habits. The disease can be classified into different types based on the cells where it starts, with epithelial ovarian cancer being the most common. It is known for being resistant to certain treatments, such as platinum-based chemotherapy, especially in recurrent cases. The progression of the disease can vary, with some cases showing resistance to treatment and others responding to therapy.

  • Fallopian Tube Cancer

    This rare cancer originates in the fallopian tubes, which connect the ovaries to the uterus. It shares many similarities with ovarian cancer in terms of symptoms and progression. Early signs may include abnormal vaginal discharge or bleeding, pelvic pain, and a palpable mass. As the disease advances, it can spread to nearby organs and tissues. The cancer is often diagnosed at a later stage due to its subtle symptoms. Like ovarian cancer, it can be resistant to certain treatments, making management challenging.

  • Primary Peritoneal Cancer

    This cancer develops in the peritoneum, a thin layer of tissue lining the abdomen. It is closely related to epithelial ovarian cancer and shares similar symptoms and progression patterns. Symptoms may include abdominal pain, bloating, and changes in bowel habits. The disease can spread throughout the abdominal cavity, affecting various organs. It is often diagnosed at an advanced stage due to its nonspecific symptoms. The progression can be aggressive, with resistance to some treatments observed in recurrent cases.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516629-30-00Protocol codeMITO 27Estimated enrolment100 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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