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Study on Durvalumab, Paclitaxel, Carboplatin, and Olaparib for Patients with Advanced or Recurrent 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 occurs in the lining of the uterus or womb. The study involves a combination of medications, including Durvalumab and Olaparib. Durvalumab, also known by its code name MEDI4736, is a medication given through an infusion into the vein. Olaparib, also known by its code name AZD2281, is taken orally in the form of film-coated tablets. The purpose of the study is to evaluate the effectiveness and safety of these medications when used together with standard chemotherapy drugs, Paclitaxel and Carboplatin, in patients who have newly diagnosed advanced or recurrent endometrial cancer.

Participants in the study will receive a combination of these treatments. Initially, they will be given Paclitaxel and Carboplatin along with Durvalumab. After this initial phase, some participants will continue to receive Durvalumab alone, while others will receive Durvalumab in combination with Olaparib. The study is designed to compare these different treatment approaches to see which is most effective in preventing the cancer from progressing.

The study will be conducted over a period of time, with regular monitoring to assess the health and response of the participants to the treatments. The goal is to determine how well these treatments work in extending the time patients live without their cancer getting worse and to evaluate the overall safety of the treatment combinations. Participants will be closely observed for any side effects or changes in their condition throughout the study.

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

    Initial treatment phase

    The initial treatment phase involves the administration of chemotherapy drugs, specifically carboplatin and paclitaxel. These medications are used to treat endometrial cancer, which affects the lining of the uterus.

    During this phase, the chemotherapy drugs are given to the patient to help reduce the size of the cancer and prevent it from spreading further.

  2. Step 2

    Combination therapy with durvalumab

    Following the initial chemotherapy, the patient receives durvalumab, a medication administered through an intravenous infusion. This is a type of immunotherapy that helps the immune system recognize and attack cancer cells.

    Durvalumab is given in combination with the chemotherapy drugs to enhance the treatment's effectiveness.

  3. Step 3

    Maintenance therapy

    After the combination therapy, the patient enters the maintenance phase. In this phase, durvalumab is continued to help maintain the response achieved with the initial treatments.

    Depending on the specific treatment arm, the patient may also receive olaparib, which is taken orally in the form of film-coated tablets. Olaparib is used to further support the treatment by targeting cancer cells at a molecular level.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, the patient's health and response to the treatment are closely monitored. This includes regular check-ups, imaging tests, and laboratory assessments to evaluate the effectiveness of the treatment and to detect any potential side effects.

    The trial aims to assess various outcomes, such as progression-free survival, overall survival, and the duration of response to the treatment.

Who can join the trial?

8 criteria

  • Must be a female who is at least 18 years old at the time of screening.
  • Must have a confirmed diagnosis of **epithelial endometrial carcinoma**. This includes all types of this cancer, except for sarcomas.
  • Must have endometrial cancer in one of these categories:
    • Newly diagnosed **Stage III disease** with measurable disease after surgery or a biopsy.
    • Newly diagnosed **Stage IV disease**, with or without disease after surgery or a biopsy.
    • Recurrent disease, which means the cancer has come back, and it is either measurable or not measurable, where surgery alone or with other treatments is unlikely to cure it.
    • Must not have received any first-line systemic anti-cancer treatment. If the patient has recurrent disease, previous treatment is allowed only if it was given as part of the initial treatment and at least 12 months have passed since the last dose of chemotherapy before the cancer returned.
    • A **FFPE tumor sample** must be available for **MMR evaluation**. FFPE stands for formalin-fixed, paraffin-embedded, which is a way of preserving tissue samples. MMR evaluation checks for certain genetic features of the tumor.
    • Must have an **ECOG performance status** of 0 or 1 within 7 days of starting the study treatment. This is a scale used to assess how well a patient can perform daily activities, where 0 means fully active and 1 means some restrictions but still able to do light work.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with endometrial cancer cannot participate. Endometrial cancer is a type of cancer that begins in the lining of the uterus.
  • Only female patients are eligible, so male patients cannot participate.
  • Patients who are not newly diagnosed with advanced or recurrent endometrial cancer are excluded.
  • Patients who are not considered part of a vulnerable population are excluded. A vulnerable population may include individuals who are at a higher risk of harm or exploitation.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer. In this trial, it is used as part of the initial treatment to help stop the growth of cancer cells in patients with advanced or recurrent endometrial cancer.

  • Paclitaxel

    is another chemotherapy drug that works by stopping cancer cells from dividing and growing. It is used in combination with carboplatin to enhance the effectiveness of the treatment in the initial phase of the trial.

  • Durvalumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. In this trial, it is used both in combination with chemotherapy and as a maintenance therapy to help prevent the cancer from returning or progressing.

  • Olaparib

    is a targeted therapy that works by interfering with the cancer cells' ability to repair their DNA, leading to cell death. In this trial, it is used in combination with durvalumab during the maintenance phase to potentially improve outcomes for patients.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating endometrial cancer. It is an immunotherapy drug that works by blocking a protein called PD-L1, which helps cancer cells evade the immune system. By inhibiting this protein, durvalumab allows the immune system to better recognize and attack cancer cells. It is classified as a monoclonal antibody and is being evaluated for its potential to improve progression-free survival in combination with chemotherapy.

  • Olaparib

    Olaparib is taken orally and is being investigated in clinical trials as a maintenance therapy for endometrial cancer. It is a targeted therapy known as a PARP inhibitor, which works by interfering with the DNA repair process in cancer cells, leading to cell death. This mechanism is particularly effective in cancer cells with specific genetic mutations. Olaparib is classified as an antineoplastic agent and is being studied for its ability to enhance the effects of immunotherapy in combination with durvalumab.

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 after menopause, but it can occur in younger women as well. The disease often presents with symptoms such as abnormal vaginal bleeding or discharge, pelvic pain, and weight loss. As the cancer progresses, it may invade the muscular layer of the uterus and spread to nearby organs or lymph nodes. In advanced stages, it can metastasize to distant parts of the body, such as the lungs or liver. Early detection and monitoring of symptoms are crucial for managing the progression of this disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502746-27-00Protocol codeD9311C00001Estimated enrolment809 patientsSponsorAstraZeneca AB

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