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Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Pembrolizumab plus autologous dendritic cell vaccine in patients with advanced mesothelioma who have failed prior therapies

This is an early research study (called a Phase 1 trial) looking into a new treatment for advanced mesothelioma. This type of cancer affects the lining of the lungs or abdomen. The treatment involves giving a medicine called pembrolizumab, which helps their immune system fight cancer, alongside a special 'autologous dendritic cell vaccine'. This vaccine is created using the patient's own cells and is designed to boost their immune response further. The study is for people whose mesothelioma hasn't gotten better with standard treatments. Researchers want to see if this combination therapy is safe and what effects it has on the body.

At a glance

Status
Ongoing, recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Enrolment target
18
Start
05 Aug 2024

What is this study about?

This study is an early research trial, often called a Phase 1 study. Its main goal is to find out if a new combination treatment for advanced mesothelioma is safe to use and how it affects people. Mesothelioma is a rare but serious cancer that usually starts in the lining of the lungs, but can also affect the lining of the abdomen or heart. This study is for people who have already tried other treatments for their mesothelioma, but those treatments haven't worked or are no longer effective.

The new treatment combines two different approaches. One part is a medicine called pembrolizumab. This is a type of immunotherapy, which means it works by helping your body's own immune system find and fight cancer cells. The other part is something called an 'autologous dendritic cell vaccine'. 'Autologous' means it's made from your own cells. Dendritic cells are a type of immune cell that are very good at showing your immune system what to attack. In this study, these cells are taken from you, specially prepared to recognise your cancer, and then given back to you as a vaccine.

The researchers want to see how these two treatments work together. Because it's an early-stage study, they will be very carefully watching participants for any side effects and how their bodies react to the treatment. This kind of research is crucial for developing new and better ways to treat serious illnesses like mesothelioma.

Key takeaways

  • This is an early-stage (Phase 1) research study.
  • It's testing a new combination treatment for advanced mesothelioma.
  • The treatment involves a drug called pembrolizumab and a special 'vaccine' made from your own cells.
  • It's for people whose mesothelioma has not responded to previous treatments.
  • The main goals are to check for safety and how the body reacts to the new treatment.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 or older. Both men and women are welcome to take part.

The study is specifically for people who have been diagnosed with advanced mesothelioma. This means the cancer has spread or is difficult to treat with standard methods. Importantly, you would also need to have tried other treatments for your mesothelioma in the past, and those treatments must not have been successful in controlling your cancer.

Quick self-check
  • Are you 18 years old or older?
  • Have you been diagnosed with advanced mesothelioma?
  • Have you already tried other treatments for your mesothelioma that didn't work well?
  • Are you willing and able to undergo regular medical checks and treatments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

As this is an early-stage study, participation would involve regular hospital visits for assessments, including blood tests, physical examinations, and scans to monitor your health and the effects of the treatment. You would receive the pembrolizumab medication and the special vaccine according to a specific schedule set by the study doctors. The exact number of visits and the full duration of your active treatment period would be explained in detail by the study team. After your treatment period, there would likely be a follow-up period to continue monitoring your health, which could involve fewer, less intensive visits or check-ins.

Potential risks and benefits

Taking part in any medical study carries potential benefits and risks. Potential benefits in this study include receiving a new experimental treatment that might help your mesothelioma when other treatments haven't. You would also contribute to medical knowledge, helping others in the future. Potential risks include side effects from the experimental drugs, which can vary widely and might be serious, as well as the inconvenience of frequent hospital visits and procedures. You would receive detailed information about all known and potential risks. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

  • Italy

Common questions

What is mesothelioma?

Mesothelioma is a rare type of cancer that affects the thin layers of tissue covering some of your internal organs, most commonly the lungs.

What is a Phase 1 study?

A Phase 1 study is the first stage where a new treatment is tested in people. The main goals are to check if it's safe, how much can be given, and what side effects it might have.

What does 'autologous dendritic cell vaccine' mean?

It's a special vaccine made from your own immune cells (dendritic cells) that are trained to recognise and fight your specific cancer cells.

Will this cure my cancer?

This is an early-stage study, so it's too soon to say if this treatment will cure mesothelioma. The aim is to understand its safety and initial effects.

Who can I talk to if I have questions?

You should speak to your doctor or the research team involved in the study. They can provide detailed information and answer all your questions.

How to find out more

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

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