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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients (DUO-O).

This clinical trial, called DUO-O, is testing a new treatment approach for women recently diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer. These are cancers that start in the reproductive organs or the lining of the abdomen. The study compares a combination of existing chemotherapy and two newer drugs, durvalumab and bevacizumab, followed by continued treatment with durvalumab, bevacizumab, and olaparib, against standard care. "Advanced" means the cancer has spread. The main goal is to find out if this new combination can help patients live longer without their cancer getting worse, which doctors call "progression-free survival." It's a large study that uses a fair method to test if these new treatments are better.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
AstraZeneca AB
Enrolment target
825
Start
04 Oct 2024

What is this study about?

This study, known as DUO-O, is a very important trial looking into new ways to treat advanced ovarian, fallopian tube, and primary peritoneal cancer. These are types of cancer that often start in the female reproductive organs or the lining of the abdomen. When we say "advanced," it means the cancer has spread beyond its original location.

Currently, there are established ways to treat these cancers. This study explores if adding certain newer drugs, durvalumab and bevacizumab, to standard chemotherapy, and then continuing with durvalumab, bevacizumab, and another drug called olaparib, can improve outcomes. We want to see if this new combination can help patients live longer without their cancer growing or spreading further. This is a common and serious illness, so finding more effective treatments is a high priority.

Because this is a "Phase III" study, it means the treatments have already been tested in smaller groups, and now we're testing them in a larger group of people to confirm if they are safe and effective. The study compares the new treatment plan against existing approaches in a fair way, like flipping a coin to decide who gets which treatment, so we can clearly see the benefits, if any, of the new combination.

Key takeaways

  • This study is for women with newly diagnosed advanced ovarian, fallopian tube, or primary peritoneal cancer.
  • It tests a new combination of existing and newer drugs.
  • The main goal is to see if the new treatment helps patients live longer without their cancer growing.
  • Participation involves regular clinic visits, treatments, and long-term follow-up.

Who may be eligible?

This study is looking for women who have recently been diagnosed with certain types of advanced cancer: specifically, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer. "High-grade" means the cancer cells look more abnormal under a microscope and might grow faster.

To be considered for this study, you must be at least 18 years old. As the cancers being studied are specific to female anatomy, participants must be female.

There are other specific medical requirements that your doctor would check to make sure the study treatments are safe and suitable for you. This often includes things like your general health, how well your organs are working, and if you have certain other medical conditions.

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. Have I been recently diagnosed with advanced ovarian, fallopian tube, or primary peritoneal cancer?
  2. Am I at least 18 years old?
  3. Am I female?
  4. Has my doctor confirmed my cancer is 'high-grade epithelial'?
  5. Am I generally well enough to undergo cancer treatment?
Answer every question to see your result.

What does participation involve?

If you join this study, you would first have a series of checks to confirm you're eligible. Once enrolled, you'd receive your assigned treatment, which could involve a combination of drugs given through an IV (into a vein) and tablets. This treatment would be given in cycles, meaning you'd have periods of treatment followed by breaks.

You would have regular visits to the clinic for medical check-ups, blood tests, and scans to monitor your health and how the treatment is working. These visits might be frequent initially and then become less often over time. If you receive maintenance treatment, this would continue after the initial chemotherapy period.

The total duration of your participation would involve the treatment period itself and then a long-term follow-up. This follow-up involves occasional checks, even after you've finished taking the study drugs, to track your progress over many years. You might be asked to fill out questionnaires about how you're feeling to help us understand your quality of life during treatment.

Potential risks and benefits

Participating in any clinical trial comes with potential benefits and risks. You might benefit from receiving new treatments that could be more effective than standard options. However, it's also possible the new treatments won't work for you, or they could cause side effects that are unexpected or severe. The study drugs, like any medicine, can have side effects. Your care team will monitor you closely for any unwanted reactions. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (12)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Belgium
  • Unverified
    Italy
  • Unverified
    Spain
  • Unverified
    France
  • Unverified
    Finland
  • Unverified
    Bulgaria
  • Unverified
    Denmark
  • Unverified
    Romania
  • Unverified
    Hungary
  • Unverified
    Austria
  • Unverified
    Germany
  • Unverified
    Poland

Common questions

What does 'advanced ovarian cancer' mean?

It means the cancer has spread beyond the ovary to other parts of your body, usually within the abdomen, when it was first diagnosed.

What is 'randomised'?

It means you'd be put into a treatment group by chance, like flipping a coin, to make sure the study is fair and accurate in comparing treatments.

What does 'Progression-Free Survival' (PFS) mean?

It's the length of time a person lives with the disease without it getting worse or spreading further. It's a key way to measure if a treatment is working.

Are the study drugs already approved?

Some drugs used in the study are standard treatments, while others are being tested in this specific combination and for this stage of cancer to see if they're more effective.

Will I know which treatment I am receiving?

This is a 'double-blind' study, meaning neither you nor your doctors will know which specific treatment group you are in. This helps ensure fair results.

How to find out more

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

Discussion

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