Active not recruitingPHASE2INTERVENTIONAL

Randomized, Double-blind Study Comparing Tremelimumab to Placebo in Subjects With Unresectable Malignant Mesothelioma

This study is investigating a new drug called tremelimumab for people with malignant mesothelioma, a type of cancer affecting the lining of the lungs or abdomen, when surgery is not an option. It's a 'Phase 2b' study, which means it's testing the drug's effectiveness and safety in a larger group of patients. Participants will be randomly assigned to receive either tremelimumab or a placebo (a dummy treatment) without knowing which one they are getting. The study aims to recruit around 564 people across different countries to understand how tremelimumab compares to current approaches and potentially offer a new treatment option.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

MedImmune LLC

Enrolment target

571

Start

17 May 2013

Estimated completion

30 Jun 2026

Unresectable Pleural or Peritoneal Malignant Mesothelioma

What is this study about?

This study is looking into a new medication, tremelimumab, for people diagnosed with malignant mesothelioma, a type of cancer that affects the thin linings around the lungs (pleural) or abdomen (peritoneal). For these patients, surgery isn't an option to remove the cancer. The main goal of this research is to see if tremelimumab can be an effective and safe treatment. By carefully comparing it to a 'dummy' treatment (placebo), the researchers hope to understand if tremelimumab offers a real benefit.

This is a 'Phase 2b' study, which means it's a crucial step in testing new treatments. It's designed to gather more information about how well tremelimumab works and its potential side effects in a larger group of people, after initial smaller studies have shown some promise. Participants will be randomly assigned, like flipping a coin, to receive either tremelimumab or the placebo. Neither the patients nor their doctors will know who is receiving which treatment, to ensure the results are as fair and unbiased as possible.

Approximately 564 people from various countries are expected to join this study. The information gathered will be vital for determining if tremelimumab could become a new treatment option for people living with malignant mesothelioma that cannot be surgically removed. It's a process of careful investigation to find better ways to manage this condition.

Key takeaways

This study is testing tremelimumab, a new drug, for malignant mesothelioma that can't be surgically treated.
It's a 'Phase 2b' study to see how well the new drug works and if it's safe.
Participants will be randomly assigned to receive either tremelimumab or a dummy treatment (placebo).
Neither you nor your doctor will know which treatment you are receiving.
Around 564 people are expected to take part in this research across different locations.
Close medical monitoring and follow-up are part of participating in the study.

Who may be eligible?

To join this study, people generally need to be 18 years or older and have a confirmed diagnosis of malignant mesothelioma in the lining of their lungs or abdomen that cannot be removed by surgery. You would have already received one or two courses of other treatments for advanced mesothelioma, including a specific type of chemotherapy called pemetrexed (or similar) combined with a platinum-based drug.

It's important that you have recovered well from any side effects of your previous treatments, and you should be generally well enough to go about your daily activities with little or no difficulty. You would also need to have healthy bone marrow, liver, and kidney function, and test negative for certain viruses like HIV and hepatitis.

Those who have had more than two previous systemic treatments for their cancer would not be suitable for this study. Women who could become pregnant and men whose partners could become pregnant will need to use effective contraception during and after the study. The study team will discuss all these criteria with you in detail.

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.

Are you 18 years or older?
Do you have confirmed malignant mesothelioma that cannot be removed by surgery?
Have you already had 1 to 2 prior chemotherapy treatments, including one with pemetrexed (or similar) and a platinum-based drug?
Are you generally well and have recovered from side effects of previous treatments?
Are you willing to use contraception if you or your partner could become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, known as the 'treatment period', you'll have regular appointments at the study centre. Before starting treatment, there will be a 'screening period' to check if the study is right for you, which involves various tests. During the treatment period, you'll receive either tremelimumab or a placebo, according to a schedule decided by the study doctors. After your treatment finishes, there will be a 90-day 'follow-up period' where the team will monitor your health and any side effects. Following this, there will be a 'long-term survival follow-up period' to track your overall health over time. The exact number of visits and the full duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study means you might receive a new treatment that could potentially help your condition, though there's no guarantee. You'll also receive close medical attention and monitoring throughout the study. However, like all medications, tremelimumab may have side effects, and since it's a new investigational drug, not all side effects are fully known. Receiving the placebo treatment means you won't get the active drug being tested. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (104)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Scottsdale, United States
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La Jolla, United States
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Los Angeles, United States
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San Francisco, United States
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Santa Monica, United States
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New Haven, United States
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Newark, United States
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Tampa, United States
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Augusta, United States
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Chicago, United States
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Peoria, United States
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Baltimore, United States

Common questions

What is malignant mesothelioma?

It's a rare and aggressive type of cancer that develops in the lining around the lungs (pleura) or, less commonly, the abdomen (peritoneum). It's often linked to asbestos exposure.

What is tremelimumab?

Tremelimumab is an investigational drug, meaning it's still being studied. It's a type of immunotherapy that works by helping your body's immune system fight cancer cells.

What does 'randomized' and 'double-blind' mean?

Randomized means you're assigned to a treatment group by chance. Double-blind means neither you nor your study doctor will know if you're receiving the new drug or the placebo, to keep the results fair.

What is a 'placebo'?

A placebo is an inactive substance or treatment that looks exactly like the real medication but contains no active drug. It helps researchers compare the effects of the new drug.

Will I still receive standard care if I join this study?

This study is for people whose cancer can't be removed by surgery and who have had previous treatments. The study drug is given as part of a research plan, and your usual medical team will ensure appropriate care throughout.