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Study of dostarlimab treatment before surgery in patients with stage II-III endometrial cancer with specific genetic markers

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 study focuses on patients with endometrial cancer, specifically stage II-III disease with certain genetic characteristics (MMRd/MSI-H). Endometrial cancer is a type of cancer that begins in the lining of the uterus. The study will test a medication called dostarlimab, which is given through an intravenous infusion (delivered directly into a vein).

The purpose of this research is to evaluate how well dostarlimab works when given before surgery (as neoadjuvant therapy) in treating this specific type of endometrial cancer. During the study, participants will receive dostarlimab infusions, with each dose being 500 mg. The treatment may continue for up to 66 weeks, with regular medical check-ups to monitor the patient's condition.

Throughout the study, doctors will use various imaging tests such as MRI, CT scan, and PET scan to check how the cancer responds to treatment. They will also perform physical examinations and monitor for any side effects. The total amount of dostarlimab that a patient might receive during the entire study period could reach up to 12,000 mg.

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 evaluation

    Your eligibility for the trial will be confirmed through medical tests and examinations

    A tissue sample will be analyzed by a central laboratory to confirm MMRd status

    Basic health parameters will be checked, including blood tests, liver function, and kidney function

  2. Step 2

    Treatment phase - Dostarlimab administration

    JEMPERLI (dostarlimab) 500 mg will be administered through an intravenous infusion

    The treatment is given before any surgery (neoadjuvant therapy)

    Regular monitoring of your health status will occur during the treatment period

  3. Step 3

    Response evaluation

    Your response to treatment will be evaluated using several imaging methods:

    - Magnetic Resonance Imaging (MRI)

    - Computed Tomography (CT) scan

    - PET scan

    A physical examination will also be performed

  4. Step 4

    Treatment outcome assessment

    The medical team will determine if the cancer has completely responded to treatment

    Based on the evaluation results, a decision will be made regarding the need for surgery

    If surgery is performed, the removed tissue will be examined to confirm the treatment's effectiveness

  5. Step 5

    Follow-up period

    Regular check-ups will continue to monitor your health status

    Any side effects will be recorded and managed according to standard guidelines

    The follow-up period will include regular assessments to check for any signs of cancer recurrence

Who can join the trial?

15 criteria

  • Must be a female aged 18 years or older
  • Must be able to understand study procedures and provide written consent to participate
  • Must have a newly diagnosed endometrial cancer (specifically endometrioid type) confirmed by laboratory tests
  • Must have MMRd status (a specific genetic characteristic of the tumor) confirmed by laboratory testing
  • Must be able to provide adequate tumor tissue sample for testing
  • Must have stage II or III disease (cancer that has not spread beyond the pelvic area)
  • Must have good physical functioning ability (ECOG status of 0 or 1, meaning able to perform daily activities)
  • Must not have received any previous cancer treatments, including radiation or hormone therapy
  • Must have adequate organ function as shown by blood tests, including:
    • Adequate blood cell counts
    • Normal liver function
    • Adequate kidney function
    • Normal blood clotting tests
    • If of childbearing potential, must:
      • Use highly effective contraception during the study and for 120 days after
      • Not be pregnant or breastfeeding
      • Agree not to donate eggs during this period

Who cannot join the trial?

10 criteria

  • Male patients (study is only for female participants)
  • Patients younger than 18 years old
  • Patients who do not have confirmed MMRd/MSI-H endometrial cancer (a specific type of uterine cancer with certain genetic characteristics)
  • Patients with cancer stages other than stage II-III
  • Patients who belong to vulnerable populations (such as persons with mental disabilities, prisoners, or others unable to give informed consent)
  • Patients who cannot provide informed consent for participation
  • Patients who are currently participating in other clinical trials
  • Patients who are pregnant or breastfeeding
  • Patients with severe allergic reactions to similar medications in the past
  • Patients with uncontrolled medical conditions that could interfere with the study treatment
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Investigated drugs

Dostarlimab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, dostarlimab helps your immune system recognize and destroy cancer cells, particularly in endometrial cancer. This medication is given through an intravenous (IV) infusion, which means it's delivered directly into your bloodstream through a vein.

What is already known about the treatment

Dostarlimab – A monoclonal antibody medication administered through intravenous infusion, primarily used in the treatment of endometrial cancer, particularly in cases with specific genetic markers (MMRd/MSI-H). This immunotherapy drug works by blocking PD-1 receptors on T-cells, which helps the immune system recognize and attack cancer cells more effectively. As a relatively new addition to cancer therapeutics, dostarlimab belongs to the class of immune checkpoint inhibitors and has shown promising results in clinical trials for treating endometrial cancer, especially when used as a neoadjuvant therapy (treatment given before the main treatment) in stage II-III cases.

Investigated diseases

Endometrial Cancer with MMRd/MSI-H - A specific type of cancer that begins in the lining of the uterus (endometrium) characterized by DNA mismatch repair deficiency (MMRd) or high levels of microsatellite instability (MSI-H). This form of endometrial cancer shows specific genetic changes that affect how DNA repairs itself. The condition specifically refers to stage II-III disease, meaning the cancer has grown beyond the uterus but remains confined to the pelvic region. The cancer develops when cells in the endometrium begin to grow out of control due to these specific genetic alterations. These genetic characteristics (MMRd/MSI-H) make the tumor cells grow and divide in a particular way that distinguishes them from other types of endometrial cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512021-81-00Protocol codeGEICO 137-EEstimated enrolment25 patientsSponsorFundacion Grupo Espanol De Investigacion En Cancer Ginecologico

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