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Study of Pembrolizumab for Patients with Mismatch Repair Deficient Uterine 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 a type of uterine cancer known as mismatch repair deficient endometrial cancer. The treatment being tested is a medication called pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is given as a solution 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 effective pembrolizumab is in treating this specific type of uterine cancer before surgery.

Participants in the study will receive pembrolizumab over a series of 9 treatment cycles. The main goal is to see how many patients experience a significant reduction in their cancer after these cycles. This reduction is referred to as a major pathologic response, which means the cancer has shrunk significantly when examined under a microscope. The study will also look at other factors, such as how long patients remain free from cancer recurrence after treatment and the safety of using pembrolizumab in this way.

The trial aims to gather information that could lead to further research comparing this treatment approach to other standard treatments. By understanding how pembrolizumab works in this setting, researchers hope to improve treatment options for patients with mismatch repair deficient uterine cancer in the future.

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

    Joining the study

    Upon joining the study, the participant must provide written informed consent. This consent confirms understanding and agreement to participate in the trial.

    Eligibility criteria include being a female participant at least 18 years old with a confirmed diagnosis of mismatch repair deficient (MMRd) uterine cancer. The participant must not be pregnant or breastfeeding and must agree to follow contraceptive guidance during the treatment period.

  2. Step 2

    Treatment with pembrolizumab

    The treatment involves receiving pembrolizumab, which is administered as an intravenous infusion. The product used is KEYTRUDA 25 mg/mL concentrate for solution for infusion.

    The treatment consists of 9 cycles of pembrolizumab. Each cycle is administered according to the schedule provided by the medical team.

  3. Step 3

    Monitoring and assessment

    Throughout the treatment, the participant's response to pembrolizumab is monitored. This includes assessing the tumor's response using imaging techniques such as MRI and criteria known as RECIST1.1.

    The safety and tolerability of the treatment are also evaluated during this period.

  4. Step 4

    Surgery

    Following the completion of the 9 cycles of pembrolizumab, the participant is scheduled for a standard-of-care hysterectomy, which is a surgical procedure to remove the uterus.

  5. Step 5

    Follow-up

    After surgery, the participant's health and any recurrence of the disease are monitored for up to 2 years from the initial diagnosis.

    The main goal is to determine the fraction of patients achieving a major pathologic response (MPR) and to assess recurrence-free survival.

Who can join the trial?

6 criteria

  • Participants must be **female** and at least **18 years old**.
  • Participants must have a confirmed diagnosis of a specific type of **uterine cancer** known as **G3/CC MMRd uterine cancer**. This means the cancer has a certain characteristic called **mismatch repair deficiency**.
  • Participants should be planning to have a **hysterectomy**, which is a surgery to remove the uterus.
  • Participants must not be **pregnant** or **breastfeeding**.
  • If participants are of childbearing age, they must agree to use **contraception** during the treatment and until the hysterectomy is performed.
  • Participants must provide **written informed consent**, which means they agree to participate in the trial after being informed about it.

Who cannot join the trial?

3 criteria

  • Patients who do not have **mismatch repair deficient endometrial cancer** or **uterine cancer** cannot participate. **Mismatch repair deficient** means that the cancer cells have a problem fixing mistakes in their DNA.
  • Only female patients are eligible for this study. Male patients cannot participate.
  • Patients who are considered part of a **vulnerable population** are not eligible. **Vulnerable population** refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

Pembrolizumab is a medication used in this trial as a treatment for uterine cancer. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this study, patients receive pembrolizumab before surgery to see if it can shrink the tumor and improve surgical outcomes. The goal is to determine how many patients experience a significant reduction in their cancer after receiving this treatment.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered intravenously, typically through an infusion into a vein. It is currently being studied in clinical trials as a potential treatment for mismatch repair deficient endometrial cancer, also known as uterine cancer. The medication is classified as an immune checkpoint inhibitor and works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is primarily used in oncology to treat various types of cancer by enhancing the body's immune response against tumor cells.

Investigated diseases

Mismatch Repair Deficient Endometrial Cancer – This type of cancer occurs in the lining of the uterus and is characterized by a deficiency in the mismatch repair system, which is responsible for correcting errors during DNA replication. This deficiency leads to an accumulation of mutations, contributing to cancer development. The disease often presents with symptoms such as abnormal uterine bleeding, especially in postmenopausal women. As the cancer progresses, it may invade deeper layers of the uterus and potentially spread to other parts of the body. The progression can vary, with some cases remaining localized while others may metastasize. Understanding the specific genetic mutations involved is crucial for determining the course of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516736-10-00Protocol codePAM-UMCG-002Estimated enrolment12 patientsSponsorUniversitair Medisch Centrum Groningen

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