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Study on Durvalumab for Patients with High-Risk Endometrial Cancer After Surgery

Fast replyRegistered 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 cancer called endometrial cancer, which affects the lining of the uterus. Specifically, the trial is looking at a subtype known as mismatch-repair deficient high-risk endometrial cancer (MMRd HREC). This subtype is characterized by certain genetic features that make it more aggressive. The treatment being tested in this study is a medication called durvalumab, also known by its code name MEDI4736. Durvalumab is given as an infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to see if this treatment can help prevent the cancer from coming back after surgery. Participants in the study will receive durvalumab infusions and will be monitored over a period of time to check for any signs of cancer recurrence. The study aims to follow patients for up to three years to assess how well the treatment works in keeping the cancer from returning.

Throughout the study, participants will have regular check-ups and tests to monitor their health and the status of their cancer. These tests may include imaging scans like MRI or CT scans, which help doctors see inside the body. The study will also look at the overall health and quality of life of participants, as well as any side effects they may experience from the treatment. The goal is to gather information that could lead to better treatment options for people with this type of endometrial 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be required to provide written informed consent, which confirms your understanding and agreement to participate in the trial.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm your eligibility. This includes reviewing your medical history, performing a physical examination, and conducting necessary laboratory tests to ensure you meet the trial's inclusion criteria.

  3. Step 3

    Treatment phase

    During the treatment phase, you will receive the medication Imfinzi (durvalumab) as an IV infusion. The dosage is 50 mg/mL, and the frequency and duration of administration will be determined by the study protocol. This phase aims to evaluate the effectiveness of the treatment in preventing cancer recurrence.

  4. Step 4

    Follow-up visits

    Regular follow-up visits will be scheduled to monitor your health and the effects of the treatment. These visits may include physical examinations, laboratory tests, and imaging studies to assess your response to the treatment and to check for any side effects.

  5. Step 5

    End of trial

    At the end of the trial, a final assessment will be conducted. This will involve a comprehensive evaluation of your health status and the collection of data to determine the trial's outcomes. You will be informed about the results and any further steps, if necessary.

Who can join the trial?

15 criteria

  • Must have a confirmed diagnosis of endometrial cancer, which is a type of cancer that starts in the lining of the uterus. This includes several subtypes like endometrioid, serous, clear cell, dedifferentiated, undifferentiated, carcinosarcoma, and mixed types.
  • Must have a WHO Performance score of 0-1, which means you are fully active or have some symptoms but can still carry out light work.
  • Must have a confirmed stage of cancer according to specific criteria, which includes certain stages with specific characteristics like LVSI (lymphovascular space invasion) or involvement of pelvic areas.
  • Must have a specific molecular classification called MMRd (mismatch repair deficient), and the POLE status must be non-pathogenic, meaning it does not have harmful mutations.
  • Must not have had any prior pelvic radiotherapy.
  • Must weigh more than 30 kg (about 66 pounds).
  • Must have adequate organ function, which includes:
    • Kidneys: Creatinine clearance greater than 40 mL/min, which is a measure of kidney function.
    • Bone marrow: Hemoglobin level greater than 9.0 g/dl, Absolute neutrophil count (ANC) of at least 1.0 x 109/l, and platelet count of at least 75 x 109/l.
    • Liver: Bilirubin level no more than 1.5 times the normal limit, and ALT (SGPT) and/or AST (SGOT) levels no more than 2.5 times the normal limit.
    • Must have had surgery to remove the uterus and ovaries, with or without removal of lymph nodes, and no visible cancer left after surgery.
    • Must not have any distant metastases, meaning the cancer has not spread to other parts of the body, as shown by imaging tests like CT, MRI, or PET-CT scans.
    • Must be 18 years of age or older.
    • If applicable, must start additional treatment within 10 weeks after surgery.
    • Must be able to attend treatment sessions and follow-up appointments.
    • Must provide written informed consent to participate in the study, agree to contribute a tissue sample for research, and allow the use and sharing of data according to ethical guidelines.

Who cannot join the trial?

7 criteria

  • Patients who do not have a confirmed diagnosis of mismatch-repair deficient high risk endometrial cancer (MMRd HREC).
  • Patients with a POLE mutation (a specific genetic change).
  • Patients who have not undergone surgery, including hysterectomy (removal of the uterus) and bilateral salpingo-oophorectomy (removal of both ovaries and fallopian tubes).
  • Patients with signs of residual disease (remaining cancer after treatment).
  • Patients with distant metastases (cancer that has spread to other parts of the body).
  • Male patients, as the study is only for female patients.
  • Patients who are considered part of a vulnerable population (groups that may need special protection).
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Investigated drugs

RAINBO: This is a clinical trial focused on refining the treatment for endometrial cancer based on specific molecular features. The trial aims to improve the survival rate of patients with a particular type of endometrial cancer, known as MMRd HREC, by studying how different treatments can prevent the cancer from coming back over a period of three years. The trial does not specify individual medications or therapies by name, but it is part of a broader effort to tailor cancer treatment to the unique characteristics of each patient's cancer.

What is already known about the treatment

RAINBO – This medication is part of a clinical trial aimed at improving treatment for patients with a specific type of endometrial cancer, known as mismatch-repair deficient high-risk endometrial cancer (MMRd HREC). It is administered to patients who have undergone surgery to remove the cancer and are being treated with the goal of curing the disease. The main focus of the trial is to see if the medication can help prevent the cancer from coming back within three years. The medication works by targeting specific molecular features of the cancer cells, although the exact mechanism of action is still being studied. It falls under the category of adjuvant cancer therapies, which are treatments given after the primary treatment to increase the chances of a cure.

Investigated diseases

Mismatch Repair Deficient High-Risk Endometrial Cancer – This type of endometrial cancer is characterized by a deficiency in the mismatch repair system, which is responsible for correcting errors during DNA replication. It is considered high-risk due to its potential for aggressive behavior and recurrence. The disease typically progresses from the inner lining of the uterus and can invade deeper layers or spread to nearby tissues and organs. In its early stages, it may be confined to the uterus, but as it advances, it can spread to the pelvic region and beyond. The progression is often marked by local invasion and potential for distant metastasis. The absence of POLE mutations and the inclusion of various histological types, such as carcinosarcoma, are notable features of this condition.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503267-42-00Protocol codeRAINBO MMRd-GREENEstimated enrolment446 patientsSponsorLeids Universitair Medisch Centrum (LUMC)

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