A Phase II, Open-Label, Single Arm, prospective, multicenter study of niraparib plus dostarlimab in patients with pleural mesothelioma positive for PD-L1 expression and germline or somatic mutations in the HRR genes
This research study is exploring a new treatment approach for people diagnosed with pleural mesothelioma, a type of cancer that affects the lining of the lungs. The study combines two existing medications, niraparib and dostarlimab, to see how well they work together. Doctors want to find out if this combination can prevent the cancer from growing or spreading for a longer time. They will also look at how many people respond to the treatment, how long any improvements last, and if the treatment is safe and tolerable. All adults aged 18 and over, of any gender, who have this specific type of cancer and certain genetic markers may be able to take part.
At a glance
What is this study about?
This study is investigating a new way to treat pleural mesothelioma, which is a type of cancer that develops in the lining of the lungs. Doctors are trying out a combination of two medications: niraparib and dostarlimab. Both of these drugs are already used to treat certain cancers, but this study explores how well they work together for pleural mesothelioma.
The main goal of the study is to see if this new combination treatment can keep the cancer from growing or getting worse for a longer period of time. This is often called 'progression-free survival'. The research team will also be looking at other important things, like how many people's cancers shrink or improve (this is called 'objective response rate'), how long any positive effects last, and how many people have their disease controlled by the treatment. They will also track how long people live overall and check carefully for any side effects to make sure the treatment is safe.
The study is a 'Phase II' trial, which means it builds on earlier research and is designed to get more information about how well the treatment works and its safety in a larger group of patients. By testing this combination, researchers hope to find a more effective treatment option for people with this condition.
Key takeaways
- A study for people with pleural mesothelioma.
- Investigates two existing drugs, niraparib and dostarlimab, in combination.
- Main goal: see if the treatment can stop cancer growth for longer.
- Also looking at treatment safety and how well patients respond.
- Open to adults aged 18+ with specific cancer characteristics.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women are welcome to participate.
You would need to have a specific type of cancer called pleural mesothelioma. In addition, your cancer cells need to show certain markers, meaning they have particular features that the doctors can identify through tests. These include 'PD-L1 expression' and changes (mutations) in genes known as 'HRR genes'.
There will be other detailed medical checks to make sure the study is right for you and that taking part would be safe. Your doctor will be able to tell you if you meet all the requirements.
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 old or older?
- Have you been diagnosed with pleural mesothelioma?
- Have your doctors confirmed that your cancer has 'PD-L1 expression'?
- Have tests shown changes (mutations) in your 'HRR genes'?
- Are you able to travel to study appointments?
What does participation involve?
If you decide to take part in this study, you'll receive the two new medications, niraparib and dostarlimab. These will be given to you at a hospital or clinic. You will have regular appointments where the doctors will monitor your health, perform tests to see how the cancer is responding, and check for any side effects. This will involve blood tests, scans, and physical examinations.
The study involves ongoing treatment and monitoring, and the total duration for each individual will vary depending on how they respond to the treatment and their overall health. There will also be follow-up appointments after you stop taking the medication to continue monitoring your health and any long-term effects. The research team will explain the full schedule of visits and tests during the consent process.
Potential risks and benefits
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Common questions
What is pleural mesothelioma?
It's a type of cancer that affects the thin lining around the lungs, called the pleura.
What are niraparib and dostarlimab?
They are different types of medicines used to treat certain cancers. This study explores them working together.
What does 'progression-free survival' mean?
It's how long a person lives without their cancer growing or getting worse.
Will this treatment cure my cancer?
This study aims to find more effective treatments. There’s no guarantee of a cure, but it might help control the disease for longer.
What if I want to stop being in the study?
You can leave the study at any time, for any reason, without it affecting your other 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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