Phase 1/2 Dose Determination and Dose Expansion Study of Cobolimab in Combination with Dostarlimab in Pediatric and Young Adult Participants with Newly Diagnosed and Relapsed/Refractory Tumors (POPSTAR)
This research study, called POPSTAR, is investigating a new treatment that combines two medicines, cobolimab and dostarlimab (also known as JEMPERLI). It's for children and young adults whose cancer has either just been diagnosed or has come back after previous treatment, and for which other treatments haven't worked or are no longer working. The main aims are to find the right dose of the new treatment, check for any side effects, and see how well it works at shrinking tumours. This study is being carried out in two main parts, first looking at safety and then how effective it is.
At a glance
What is this study about?
This study is called POPSTAR, and it's designed for children and young adults who have cancer that is new or has returned after previous treatments. The study is investigating a new combination of two medicines, cobolimab and dostarlimab (which you might know as JEMPERLI). These medicines are a type of treatment that helps your body's immune system fight cancer.
The main goal of the first part of the study is to find the safest and most effective dose of this combined treatment. The researchers will be carefully checking for any side effects. Once they've found the best dose, the second part of the study will then look more closely at how well this treatment can shrink tumours and how long the effect lasts. This is often called seeing if the treatment works.
Taking part in such a study is important because it helps doctors learn more about new ways to treat cancer, especially for cancers that are difficult to treat. While the focus is on safety and finding the right dose first, understanding how well these new treatments work could lead to better options for patients in the future.
Key takeaways
- This study is testing a new combination treatment for certain cancers in young people.
- It aims to find a safe dose and see how well the treatment works.
- It's for cancers that are newly diagnosed or have returned after other treatments.
- You would receive treatment through a drip and have regular check-ups.
- Participation could help advance cancer treatment for others.
- You can stop participating at any time.
Who may be eligible?
To be considered for this study, you would typically be a child or a young adult. The study is open to both boys and girls. Currently, the study is looking for patients aged from 18 years upwards, there isn't an upper age limit mentioned.
You would need to have been diagnosed with certain types of cancer that have either just been found or have come back after other treatments have been tried. This means your cancer has not responded to previous treatments, or it has returned despite them.
It's important to know that specific medical tests would be done to ensure you meet all the detailed health requirements for the study. Your doctor would discuss these with you to see if this study might be suitable for your particular situation.
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 cancer recently, or has it returned after previous treatments?
- Are you a child or young adult?
- Could your cancer be described as 'difficult to treat' or not responding to current options?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, JEMPERLI, through a drip into your arm. The study is in two main parts. In the first part, the doctors will find the safest dose of the treatment, which might involve different amounts of the medicine for different people. They will closely watch for any side effects.
Throughout the study, you will have regular visits to the hospital. These visits will include blood tests to check how the medicine is working and to monitor your general health. You’ll also have scans to see if your tumour is responding to the treatment. Doctors will also check your heart and other important body functions.
After you stop receiving the treatment, you'll have follow-up appointments for up to 90 days to keep an eye on your health and check for any delayed side effects. The total length of your participation will depend on which part of the study you are in and how you respond to the treatment.
Potential risks and benefits
Locations (6)
- —UnverifiedSpain
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- —UnverifiedItaly
- —UnverifiedCzechia
Common questions
What is JEMPERLI?
JEMPERLI is one of two medicines being tested in this study. It's a type of cancer treatment that works with your body's immune system.
Who is this study for?
This study is for children and young adults who have newly diagnosed cancer or cancer that has returned and not responded to other treatments. Participants must be 18 years or older.
What does 'Phase 1/2' mean?
This means the study has two main parts. Phase 1 focuses on finding the safest dose and checking for side effects. Phase 2 looks at how well the treatment works.
Will I get better if I join this study?
We cannot guarantee you will get better. This study is testing if a new treatment works, and there is no guarantee of benefit. However, you will be closely monitored by medical professionals.
Can I stop being in the study at any time?
Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.
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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