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Active not recruitingPHASE3INTERVENTIONAL

Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer

This research study is for women with advanced or recurrent womb (endometrial) cancer. Researchers want to see if adding specific medications, durvalumab and olaparib, helps after standard chemotherapy. The study will look at how well these new treatments work and if they are safe. Participants will first receive a combination of chemotherapy drugs (carboplatin and paclitaxel) along with durvalumab. After this initial treatment, they will then continue with maintenance treatment of durvalumab, either with or without olaparib. The aim is to find better ways to help patients with womb cancer, focusing on improving their treatment outcomes and quality of life. This is a Phase 3 study, meaning it's a large trial testing treatments that have shown promise in earlier stages.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
805
Start
05 May 2020
Estimated completion
01 Apr 2027

Results

Results from this study

Posted December 2025

Results have been published for this study.

Primary outcome
Progression-free Survival (PFS) According to RECIST 1.1, Based on Investigator Assessments
To demonstrate the efficacy of durvalumab in combination with platinum-based chemotherapy (paclitaxel and carboplatin) followed by maintenance durvalumab or durvalumab with olaparib when compared to platinum-based chemotherapy by assessment of PFS (using investigator assessment according to Response Evaluation Criteria in Solid Tumours version 1.1 \[RECIST 1.1\]) in patients with newly diagnosed advanced or recurrent endometrial cancer
Full results on the registry

What is this study about?

This study is investigating new treatment options for women who have advanced or recurrent womb (endometrial) cancer. Womb cancer is a type of cancer that starts in the lining of the womb. 'Advanced' means the cancer has spread beyond the womb, and 'recurrent' means it has come back after previous treatment. The main goal of this research is to see if a combination of certain medications can improve how well patients respond to treatment and help them live longer.

The study involves giving patients a standard chemotherapy treatment, which is a common way to fight cancer, using drugs called paclitaxel and carboplatin. Alongside this chemotherapy, patients will also receive a new medicine called durvalumab. After this initial treatment phase, the study then looks at what's called 'maintenance therapy'. This is ongoing treatment designed to keep the cancer from growing or coming back. During this maintenance phase, patients will continue to receive durvalumab, and some will also receive another medicine called olaparib, while others will receive a dummy pill (placebo) instead of olaparib, to fairly compare the new treatment.

By comparing these different treatment approaches, researchers hope to understand if adding durvalumab and/or olaparib to existing treatments can make a significant difference for women with advanced or recurrent womb cancer. This is a large-scale study (Phase 3), which means the treatments have shown promise in smaller trials, and now need to be thoroughly tested in more people to confirm their benefits and safety before they can become widely available.

Key takeaways

  • This study is for advanced or recurrent womb cancer.
  • It tests new medicines (durvalumab and olaparib) after chemotherapy.
  • Aims to find more effective and safe treatments.
  • You might receive a placebo in one part of the study.
  • Participation is voluntary, you can leave any time.

Who may be eligible?

This study is looking for women who are 18 years old or older. You might be able to take part if you have a confirmed diagnosis of certain types of womb cancer (specifically, epithelial endometrial carcinoma, including carcinosarcomas, but not other types like sarcomas).

Your cancer needs to be either newly diagnosed at an advanced stage (Stage III or IV) or it needs to be a recurrence, meaning it has come back after previous treatment and surgery alone isn't expected to be enough to cure it. You should not have received any previous treatment for this current cancer, unless it was a type of treatment given after surgery to prevent recurrence, and it's been at least 12 months since you finished that treatment.

There are also some things that would mean you can't join the study. For example, if you have certain other serious health problems, if you've had previous specific types of cancer treatment (like PARP inhibitors or certain immune therapies), or if your cancer has spread to your brain or spinal cord. The study team will review your full medical history to see if you're a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you a woman aged 18 or older?
  2. Do you have advanced or recurrent womb cancer (epithelial type)?
  3. Have you not had previous treatment for this current cancer (except in specific cases)?
  4. Do you not have cancer spread to your brain or spine?
  5. Have you not taken certain immune-boosting or PARP inhibitor drugs before?
Answer every question to see your result.

What does participation involve?

If you join this study, your journey will involve a few steps. First, you'll undergo an initial treatment period where you'll receive a combination of chemotherapy drugs (carboplatin and paclitaxel) along with a medication called durvalumab. This part of the treatment will likely involve regular visits to the hospital for infusions.

After this first phase, you'll move into the maintenance phase. During this time, you'll continue to receive durvalumab. You will also either receive a medication called olaparib or a placebo (a dummy pill that looks like olaparib but contains no active medicine). Which one you receive will be decided randomly, like flipping a coin. You won't know whether you're getting olaparib or the placebo.

You'll have regular appointments throughout the study for check-ups, scans, and blood tests to monitor your health, how the treatment is working, and to check for any side effects. The total duration of your participation will depend on how you respond to the treatment and the study's protocol, but it will involve continued follow-up even after active treatment has ended.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. A potential benefit of this study is that you might receive new treatments that are not yet widely available, which could be more effective than current standard options for your condition. However, there's no guarantee the treatment will work for you, and it's possible you might experience side effects from the study medications. These side effects can range from mild to serious, and the study team will monitor you closely for them. You will be given full details of known side effects before you decide to take part. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (201)

  • Research Site
    Verified postcode
    Tucson, United States
  • Research Site
    Verified postcode
    Concord, United States
  • Research Site
    Verified postcode
    La Jolla, United States
  • Research Site
    Verified postcode
    San Francisco, United States
  • Research Site
    Verified postcode
    Santa Barbara, United States
  • Research Site
    Verified postcode
    Aurora, United States
  • Research Site
    Verified postcode
    Fort Lauderdale, United States
  • Research Site
    Verified postcode
    Tampa, United States
  • Research Site
    Verified postcode
    Savannah, United States
  • Research Site
    Verified postcode
    Honolulu, United States
  • Research Site
    Verified postcode
    Arlington Heights, United States
  • Research Site
    Verified postcode
    Chicago, United States

Common questions

What is womb cancer?

Womb cancer, also known as endometrial cancer, is a type of cancer that starts in the lining of the uterus (womb).

What is a 'Phase 3' study?

A Phase 3 study is a large-scale clinical trial that tests if a new treatment is effective and safe compared to existing treatments, before it can be approved for general use.

What are durvalumab and olaparib?

Durvalumab is a type of immunotherapy that helps your body’s immune system fight cancer. Olaparib is a targeted therapy designed to block certain cancer cells from repairing themselves.

Will I know which treatment I'm getting?

After your initial chemotherapy and durvalumab, during the maintenance phase, you will not know if you are receiving olaparib or a placebo. This helps ensure fair comparison of the treatments.

Can I stop participating in the study?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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