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Study on Dostarlimab, Carboplatin, and Paclitaxel for Patients with Recurrent or Advanced Endometrial 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 endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study involves patients with recurrent or primary advanced stages of this cancer. The main treatment being tested is a medication called Dostarlimab, also known by its code name TSR-042. Dostarlimab is a type of drug known as a monoclonal antibody, which is designed to help the immune system fight cancer cells. In this study, Dostarlimab is combined with two chemotherapy drugs, Carboplatin and Paclitaxel, and compared to a combination of a placebo with Carboplatin and Paclitaxel. Additionally, another medication called Niraparib is being tested in combination with Dostarlimab in some parts of the study.

The purpose of the study is to determine if adding Dostarlimab to the standard chemotherapy treatment can delay the return of cancer or improve survival rates in patients with advanced endometrial cancer. The study is divided into two parts. In the first part, patients receive either Dostarlimab with chemotherapy or a placebo with chemotherapy. In the second part, some patients receive Dostarlimab with Niraparib and chemotherapy, while others receive a placebo with chemotherapy. The study is designed to be double-blind, meaning neither the patients nor the researchers know who is receiving the actual medication or the placebo, to ensure unbiased results.

Participants in the study will receive treatment over a period of time and will be monitored regularly to assess the progression of their cancer and overall health. The study aims to provide valuable information on the effectiveness of Dostarlimab and Niraparib in treating advanced endometrial cancer, potentially leading to improved treatment options for patients 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 will be randomly assigned to one of two groups. This process is called randomization and ensures that each participant has an equal chance of receiving the study treatment or a placebo.

  2. Step 2

    Initial treatment phase

    The patient will receive a combination of medications. This includes dostarlimab administered through an intravenous infusion, and two chemotherapy drugs, carboplatin and paclitaxel. The exact dosage and frequency will be determined by the study protocol and the patient's specific condition.

  3. Step 3

    Continuation of treatment

    After the initial phase, the patient will continue to receive dostarlimab or a placebo, depending on the group they were assigned to. This phase aims to maintain the treatment's effects and monitor the patient's response.

  4. Step 4

    Additional treatment phase (Part 2 only)

    In Part 2 of the study, some patients will receive an additional medication called niraparib, which is taken orally. This phase is designed to evaluate the combined effect of dostarlimab and niraparib on the patient's condition.

  5. Step 5

    Monitoring and assessments

    Throughout the study, the patient's health and response to treatment will be closely monitored. This includes regular medical assessments, imaging tests, and laboratory evaluations to track the progression of the disease and any side effects of the treatment.

  6. Step 6

    Completion of the study

    The study is expected to conclude by November 2026. At the end of the study, the patient's overall health and treatment outcomes will be evaluated to determine the effectiveness of the treatment regimen.

Who can join the trial?

19 criteria

  • The participant must be a female who is at least 18 years old and can understand the study procedures. She must agree to participate by signing a written consent form.
  • The participant must have endometrial cancer that has been confirmed through tests. The cancer should be either recurring or advanced.
  • The participant must provide a sample of their tumor tissue for testing during the screening process. This sample will be used to check specific characteristics of the cancer. The quality of the sample must be confirmed by a central laboratory before the participant can be included in the study.
  • The participant must have either primary Stage III or Stage IV endometrial cancer or a first recurrence of the cancer. The cancer should have a low chance of being cured by radiation or surgery alone. The participant must meet at least one of the following conditions:
    • Has primary Stage IIIA to IIIC1 disease with measurable or visible disease based on specific criteria. If there are any unclear areas, they should be tested to confirm the presence of a tumor.
    • Has primary Stage IIIC1 disease with specific types of cancer cells, regardless of measurable disease on imaging.
    • Has primary Stage IIIC2 or Stage IV disease, regardless of measurable disease.
    • Has a first recurrence of the disease and has not received systemic anticancer therapy before.
    • Has received prior anticancer therapy before surgery and had a recurrence or disease progression at least 6 months after completing treatment.
    • The participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means they are fully active or have some symptoms but do not need bed rest.
    • The participant must have adequate organ function, which includes:
      • A certain level of white blood cells called neutrophils.
      • A certain number of platelets, which help with blood clotting.
      • A certain level of hemoglobin, which carries oxygen in the blood.
      • A certain level of creatinine, which indicates kidney function, or a calculated creatinine clearance level.
      • A certain level of bilirubin, which is a substance made by the liver.
      • Certain levels of liver enzymes, which are proteins that help the liver function.
      • Certain levels of blood clotting times, which measure how well the blood clots.
      • The participant must use contraception that is highly effective if they are of childbearing potential. They must not be pregnant or breastfeeding and must agree not to donate eggs during the study and for a certain period after the last dose of study treatment. A negative pregnancy test is required before starting the study treatment.
      • For Part 2 only: The participant must have normal blood pressure or controlled high blood pressure.
      • For Part 2 only: The participant must be able to take medication by mouth.

Who cannot join the trial?

4 criteria

  • Patients who have a different type of cancer other than **endometrial cancer**. Endometrial cancer is a type of cancer that starts in the lining of the uterus.
  • Patients who are not in **Stage III or IV** of endometrial cancer. These stages indicate advanced cancer that has spread beyond the uterus.
  • Patients who are male, as the study is only for female patients.
  • Patients who are not considered part of a **vulnerable population**. This term refers to groups of people who might be at a higher risk of harm or exploitation, such as those with limited ability to give consent.
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Investigated drugs

  • Dostarlimab (TSR-042)

    is an investigational medication used in this trial to treat patients with recurrent or primary advanced endometrial cancer. It is designed to help the immune system recognize and attack cancer cells more effectively. In this study, it is used in combination with other cancer treatments to evaluate its effectiveness in improving patient outcomes.

  • Carboplatin

    is a chemotherapy drug used in this trial to treat endometrial cancer. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. Carboplatin is commonly used in combination with other chemotherapy drugs to enhance its effectiveness.

  • Paclitaxel

    is another chemotherapy medication used in this study. It helps stop the growth of cancer cells by inhibiting their ability to divide. Paclitaxel is often used alongside other chemotherapy agents to treat various types of cancer, including endometrial cancer.

  • Niraparib

    is a medication included in the second part of the trial. It is a type of targeted therapy known as a PARP inhibitor, which works by preventing cancer cells from repairing their DNA, leading to cell death. Niraparib is used in combination with other treatments to assess its potential benefits in improving the survival of patients with endometrial cancer.

What is already known about the treatment

Dostarlimab – Dostarlimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating recurrent or primary advanced endometrial cancer. It is a monoclonal antibody that works by blocking the PD-1 receptor, which helps the immune system recognize and attack cancer cells. Dostarlimab is classified as an immune checkpoint inhibitor and is being evaluated for its potential to improve progression-free survival and overall survival in patients with this type of cancer.

Investigated diseases

Endometrial Cancer – Endometrial cancer is a type of cancer that begins in the lining of the uterus, known as the endometrium. It is most commonly diagnosed in women who have gone through menopause. The disease can be classified into different stages, with Stage III and IV indicating advanced cancer that may have spread beyond the uterus. Symptoms often include abnormal vaginal bleeding, pelvic pain, and weight loss. The progression of endometrial cancer can vary, with some cases growing slowly while others may spread more rapidly. Early detection and monitoring are crucial for managing the disease effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506551-23-00Protocol code4010-03-001Estimated enrolment785 patientsSponsorTesaro Inc.

sourced from the EU Clinical Trials Register and site verification

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