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RecruitingPHASE3INTERVENTIONAL

MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

This important study, known as a Phase 3 trial, is looking into a new treatment for people with advanced pleural mesothelioma. This is a type of cancer that affects the lining of the lungs and can't be removed by surgery. The study is testing a new drug called Volrustomig, given alongside standard chemotherapy (Carboplatin and Pemetrexed). This new combination will be compared to current standard treatments, which include either a different chemotherapy combination (platinum and Pemetrexed) or a combination of two other drugs (Nivolumab and Ipilimumab). The main goal is to find out if the new treatment is more effective and has fewer side effects than the currently available options, potentially offering a better way to help patients with this challenging condition.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
825
Start
09 Nov 2023
Estimated completion
16 Nov 2028

What is this study about?

This study is a Phase 3 clinical trial, which means it's one of the final steps in testing a new treatment before it might become widely available. The focus is on pleural mesothelioma, a cancer that affects the lining around your lungs and chest. Specifically, it's for people whose mesothelioma has advanced to a point where it can't be completely removed by surgery.

The main aim is to see if a new drug combination, consisting of Volrustomig along with standard chemotherapy drugs (Carboplatin and Pemetrexed), works better than the treatments currently used. These current treatments might be a different chemotherapy combination (platinum and Pemetrexed) or a mix of two other drugs (Nivolumab and Ipilimumab). By comparing these treatments, researchers hope to find a more effective and safer way to manage this condition.

Participants in the study will be randomly assigned to receive one of these treatment approaches. This is a common way to ensure the study results are fair and unbiased. The study will carefully monitor how well each treatment works and what side effects people experience, ultimately helping doctors understand the best options for future patients with advanced pleural mesothelioma.

Key takeaways

  • Tests a new combination treatment for advanced pleural mesothelioma.
  • Compares it against current standard treatments.
  • Aims to find out if the new treatment is more effective and safer.
  • For adults aged 18 and over whose cancer cannot be removed by surgery.
  • Will closely monitor participants for treatment effects and side effects.

Who may be eligible?

To join this study, you must be 18 years or older and have a confirmed diagnosis of pleural mesothelioma that has spread and cannot be treated with surgery. Your cancer's specific type (epithelioid or non-epithelioid) must be known.

You also need to be generally well enough to participate in a clinical trial. This is assessed by doctors using a standard measure called the WHO/ECOG performance status. You need to have a score of 0 or 1, meaning you're quite active and able to look after yourself, with your health not having worsened in the two weeks before starting the study. Your body's organs, like your kidneys and liver, and your bone marrow, need to be working well, and your cancer needs to be measurable so doctors can track its response to treatment.

There are also some reasons why you might not be able to join. These include certain autoimmune diseases, other types of cancer you've had in the past (with some exceptions), or uncontrolled infections like tuberculosis, hepatitis, or HIV. You also can't be receiving other cancer treatments at the same time, or have untreated brain metastases (cancer that has spread to the brain). The study doctors will carefully review your health to make sure it's safe for you to take part.

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 18 years old or older?
  2. Do you have confirmed pleural mesothelioma that can't be removed with surgery?
  3. Are you generally well and active in your daily life (WHO/ECOG performance status 0-1)?
  4. Are your body's organs and bone marrow working well enough for the treatment?
  5. Do you have any known active autoimmune conditions or uncontrolled infections?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll first have a screening visit to check if you meet all the requirements. If you do, you'll be randomly assigned to receive one of the study treatments. This means you won't get to choose which treatment you receive; it's decided by chance, like flipping a coin, to ensure fairness in the study. You will receive either the new drug combination (Volrustomig + Carboplatin + Pemetrexed) or one of the standard treatments (either platinum + Pemetrexed or Nivolumab + Ipilimumab).

Throughout the study, you'll have regular visits to the hospital or clinic. During these visits, doctors and nurses will give you your study medication, conduct physical examinations, take blood samples, and perform imaging scans (like CT scans) to monitor your health and how the treatment is affecting your cancer. They will also ask you questions about any side effects you might be experiencing. The exact number and frequency of visits will depend on the specific treatment you receive, but you can expect several appointments over many months. After your main treatment period, there will be a follow-up period where your health will continue to be monitored.

Potential risks and benefits

Taking part in a clinical trial offers the potential benefit of accessing new treatments before they are widely available, which in this study, could be a more effective option for your mesothelioma. However, like all medical treatments, there are potential risks and side effects associated with the drugs being tested, some of which may be serious or unexpected. Your study doctor will explain all known side effects in detail. You have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (178)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Phoenix, United States· Withdrawn
  • Research Site
    Verified postcode
    Duarte, United States· Withdrawn
  • Research Site
    Verified postcode
    Santa Rosa, United States· Recruiting
  • Research Site
    Verified postcode
    Aurora, United States· Recruiting
  • Research Site
    Verified postcode
    Jacksonville, United States· Recruiting
  • Research Site
    Verified postcode
    Atlanta, United States· Recruiting
  • Research Site
    Verified postcode
    Chicago, United States· Recruiting
  • Research Site
    Verified postcode
    Baltimore, United States· Recruiting
  • Research Site
    Verified postcode
    Rochester, United States· Recruiting
  • Research Site
    Verified postcode
    St Louis, United States· Recruiting
  • Research Site
    Verified postcode
    East Brunswick, United States· Withdrawn
  • Research Site
    Verified postcode
    Commack, United States· Recruiting

Common questions

What is pleural mesothelioma?

It's a type of cancer that develops in the lining of the lungs and chest wall.

What does 'unresectable' mean?

It means the cancer can't be completely removed by surgery.

What is a Phase 3 study?

It's one of the final stages of testing a new treatment to see if it's better than existing options.

Will I know which treatment I'm getting?

Yes, this study is 'open-label', meaning both you and your doctor will know which treatment you are receiving.

Can I stop participating in the study at any time?

Yes, you are free to withdraw from the study at any point without it affecting your medical care.

How to find out more

AstraZeneca Clinical Study Information Center

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

Interested in taking part?

Register your interest

Share your details and the research team for "MEDI5752 in Combination With Carboplatin Plus Pemetrexed in …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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