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Study on Durvalumab, Olaparib, and Chemotherapy for Patients with Advanced or Recurrent Endometrial Cancer in Spain

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 the treatment of endometrial cancer, which is a type of cancer that begins in the lining of the uterus. The study is specifically looking at cases where the cancer is advanced or has returned after treatment. The treatment being tested involves a combination of medications. The first medication is durvalumab, also known by its code name MEDI4736, which is given as an infusion. An infusion is a way of delivering medication directly into the bloodstream through a vein. The second medication is olaparib, which is taken as a tablet by mouth. These medications are used together with a type of chemotherapy that contains platinum, a metal used in some cancer treatments.

The purpose of the study is to understand the safety of using durvalumab with platinum-based chemotherapy, followed by durvalumab and olaparib as a first treatment option for patients with this type of cancer. The study will follow a specific course where patients will first receive the combination of durvalumab and chemotherapy. After this initial phase, patients will continue with durvalumab and olaparib. Some patients may receive a placebo instead of the active medications to help compare the effects.

Throughout the study, the health and progress of the participants will be closely monitored to gather information on how the treatment affects them. This includes looking at any side effects and how well the cancer responds to the treatment. The study aims to provide valuable insights into the potential benefits and risks of this treatment approach for endometrial cancer.

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 treatment begins with the administration of durvalumab in combination with platinum-based chemotherapy. Durvalumab is given as an infusion, which means it is delivered directly into the bloodstream through a vein.

    This phase is designed to target and treat advanced or recurrent endometrial cancer. The specific schedule and duration of this phase will be determined by the healthcare provider based on individual patient needs and response to treatment.

  2. Step 2

    Maintenance treatment phase

    Following the initial treatment phase, the patient will continue with durvalumab in combination with olaparib. Olaparib is taken orally in the form of film-coated tablets.

    The dosage of olaparib will be either 100 mg or 150 mg, as prescribed by the healthcare provider. The frequency and duration of this maintenance phase will be tailored to the patient's response and overall health condition.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, regular monitoring will be conducted to assess the patient's response to the treatment and to identify any potential side effects. This includes routine medical examinations and possibly imaging tests.

    The healthcare team will evaluate the safety and effectiveness of the treatment, adjusting the regimen as necessary to ensure the best possible outcomes for the patient.

  4. Step 4

    End of treatment evaluation

    At the conclusion of the treatment period, a comprehensive evaluation will be performed to determine the overall impact of the therapy on the patient's cancer.

    This evaluation will include a review of the patient's health status, any changes in the cancer's progression, and the patient's quality of life throughout the trial.

Who can join the trial?

17 criteria

  • Women who are **18 years or older** at the time of screening.
  • Must have **adequate organ and bone marrow function**. This means:
    • Hemoglobin level of at least 10.0 g/dL.
    • Absolute neutrophil count (ANC) of at least 1.5 x 109/L.
    • Platelet count of at least 100 x 109/L.
    • Serum bilirubin level no more than 1.5 times the upper limit of normal, except for patients with Gilbert’s syndrome.
    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels no more than 2.5 times the upper limit of normal, or 5 times for patients with liver metastases.
    • **Creatinine clearance** (a measure of kidney function) must be greater than 51 mL/min, determined by a specific calculation or test.
    • Must provide an **informed consent form**, which includes agreeing to participate in biomarker research.
    • Must have a **confirmed diagnosis of endometrial carcinoma** (a type of cancer), with a biopsy sample available.
    • Only patients with **pMMR tumors** (a specific tumor characteristic) are allowed.
    • Must have endometrial cancer in one of these categories:
      • Newly diagnosed Stage III disease with measurable disease after surgery or biopsy.
      • Newly diagnosed Stage IV disease, even if no disease remains after surgery.
      • Recurrent disease where surgery alone is unlikely to cure.
      • Must not have received **first-line systemic anti-cancer treatment**. If they have recurrent disease, previous treatment is allowed only if it was given after surgery and at least 6 months have passed since the last treatment.
      • Must have at least one, preferably two, **tumor sample blocks** available for testing. These samples should have a certain amount of tumor cells and size.
      • Must have an **ECOG/WHO performance status** of 2 or less, which is a measure of daily living abilities. No more than 20% of patients can have a status of 2.
      • Must be **postmenopausal** or have evidence of not being able to have children. This includes a negative pregnancy test before starting treatment. Women are considered postmenopausal if they have not had a period for 12 months without another medical reason, or if they have had certain surgeries or treatments.

Who cannot join the trial?

8 criteria

  • Patients with other types of cancer besides advanced or recurrent endometrial cancer cannot participate.
  • Patients who have previously received treatment with the same drugs being tested in the study are not eligible.
  • Patients with serious health conditions that could interfere with the study treatment are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients with known allergies to the study drugs are not eligible.
  • Patients who are unable to follow the study procedures or attend study visits are excluded.
  • Patients with certain infections or diseases that could affect the study results are not eligible.
  • Patients who are participating in another clinical trial at the same time are excluded.
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Investigated drugs

  • Durvalumab

    is a medication used to help the immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this trial, it is used in combination with other treatments to help treat advanced or recurrent endometrial cancer.

  • Platinum-based Chemotherapy

    refers to a group of cancer treatments that contain the metal platinum. These medications work by damaging the DNA of cancer cells, which prevents them from growing and dividing. In this trial, platinum-based chemotherapy is used alongside durvalumab to treat endometrial cancer.

  • Olaparib

    is a medication that targets cancer cells by interfering with their ability to repair damaged DNA. This can lead to the death of cancer cells. In this trial, olaparib is used after initial treatment with durvalumab and platinum-based chemotherapy to continue fighting endometrial cancer.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating advanced or recurrent endometrial cancer. The main therapeutic indication is for use in combination with platinum-based chemotherapy, followed by durvalumab with olaparib. Durvalumab works by blocking a protein called PD-L1, which helps the immune system detect and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Olaparib

    Olaparib is taken orally in the form of tablets. It is being evaluated in clinical trials as part of a combination therapy for advanced or recurrent endometrial cancer. The primary therapeutic use is alongside durvalumab after initial chemotherapy. Olaparib functions by inhibiting an enzyme called PARP, which is involved in DNA repair, thereby preventing cancer cells from repairing themselves. It is classified as a PARP inhibitor.

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 often presents with symptoms such as abnormal vaginal bleeding or discharge. As it progresses, the cancer can invade the muscular layer of the uterus and spread to nearby organs. In advanced stages, it may metastasize to distant parts of the body, including the lungs and liver. The progression of the disease can vary, with some cases remaining localized while others spread more aggressively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514728-17-00Protocol codeD9311L00001Estimated enrolment45 patientsSponsorAstrazeneca Farmaceutica Spain S.A.

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