A Phase 1, Multicentre, Open-label, Dose-escalation and Cohort Expansion Study of Niraparib and Dostarlimab in Paediatric Patients with Recurrent or Refractory Solid Tumours
This research study is for children and young people who have solid tumours that have either returned after treatment or haven't responded well to previous therapies. Doctors are testing a combination of two medicines, called Zejula (niraparib) and JEMPERLI (dostarlimab). The first part of the study aims to find the safest and most effective dose of these medicines when given together. They will carefully watch for any side effects. Once a safe dose is found, the study will expand to see how well this combination treatment works against different types of solid tumours. The hope is to find new and better ways to treat these cancers in young patients.
At a glance
What is this study about?
This study is about finding new ways to treat solid tumours in children and young people when other treatments haven't worked or the cancer has come back. Solid tumours are types of cancer that form a lump or mass, like those found in bones, muscles, or organs. Researchers are testing two specific medicines. One is called Zejula (the active ingredient is niraparib), and the other is JEMPERLI (the active ingredient is dostarlimab).
Zejula works by stopping cancer cells from repairing themselves, which can make them die. JEMPERLI is an immunotherapy, which means it helps your body's own immune system fight the cancer cells more effectively. The doctors want to see if giving these two medicines together is safe and if it can shrink or stop the growth of these tumours in young patients. This type of study is called a 'Phase 1' study, which means it's one of the first times these treatments are being combined and tested in people, specifically in this younger age group.
The main aim of the first part of the study is to find the right amount, or 'dose,' of each medicine that can be given safely without causing too many side effects. Once they find this safe dose, they will then open the study to more young people with different types of solid tumours to see how well the treatment works. They will be looking to see if the tumours shrink or stop growing, and for how long. Finding new treatments for children with cancer is very important, especially when their cancer is hard to treat.
Key takeaways
- New study for children with solid tumours that are difficult to treat.
- Combines two medicines: Zejula (tablets) and JEMPERLI (drip).
- First goal is to find the safest dose for this age group.
- Aims to see if the combination can shrink or stop tumour growth.
- Close monitoring and support for all participants.
Who may be eligible?
This study is for children and young people, regardless of their age, who have been diagnosed with a solid tumour. This means it's not looking at blood cancers, but rather cancers that form a mass in the body.
To be considered for this study, your child's solid tumour must be one that has come back after previous treatment, or it hasn't responded as expected to other cancer therapies. Both boys and girls can take part in this research.
There will be other, more detailed entry requirements that the study doctors will check, such as your child's general health, how well their organs are working, and if they have had certain other medical conditions or treatments. These checks are important to make sure the study will be safe for your child.
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.
- Does your child have a 'solid tumour'?
- Has the tumour either returned or not responded to previous treatments?
- Is your child able to take tablets and receive medicine through a drip?
- Is your child generally well enough to take part in a study like this (your doctor will check this)?
- Are you able to attend regular hospital visits for appointments and tests?
What does participation involve?
If your child takes part in this study, they will receive two medicines: Zejula, which comes as tablets, and JEMPERLI, which is given through a drip into a vein. In the first part of the study, the dose of Zejula might be changed or given in different ways to find the safest and most effective amount. Your child will likely have regular hospital visits for check-ups, blood tests, and scans to monitor their health and see how the treatment is affecting the cancer. They will also be closely watched for any side effects.
The total length of time your child might be on the treatment can vary. It will depend on how they respond to the treatment and how they are feeling. There will be careful follow-up after the treatment period to continue monitoring their health and the effects of the medicines. The study team will explain exactly what is involved for your child, including the schedule for taking the medicines, all appointments, and how long they might be in the study.
Potential risks and benefits
Locations (5)
- —UnverifiedSpain
- —UnverifiedGermany
- —UnverifiedCzechia
- —UnverifiedHungary
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
It's for children and young people with 'solid tumours' – cancers that form a lump, and that have either come back or not responded to other treatments.
What medicines are being tested?
Two medicines called Zejula (niraparib) and JEMPERLI (dostarlimab) are being tested in combination.
Why are researchers doing this study?
They want to find a safe dose of these two medicines together and see if they can help treat cancer in children and young people.
Will my child be closely monitored?
Yes, your child will have regular check-ups, tests, and scans to ensure their safety and see how the treatment is working.
Can we stop participating if we want to?
Yes, you can choose to leave the study at any time, for any reason, without affecting your child's 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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