A Phase 1/2 Study of the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Relatlimab Plus Nivolumab in Pediatric and Young Adult Participants with Recurrent or Refractory Classical Hodgkin Lymphoma and Non-Hodgkin Lymphoma
This research study is for children and young adults under 18 who have specific types of blood cancer, Hodgkin Lymphoma or Non-Hodgkin Lymphoma, that have come back or not responded to previous treatments. It's testing a combination of two new medicines, relatlimab and nivolumab. The main goals are to find a safe dose for these medicines and to see if they help control or shrink the cancer. The study will carefully monitor for any side effects and check how the medicines are absorbed and used by the body. Ultimately, it aims to see if this new treatment can offer a better option for young people with these challenging cancers.
At a glance
What is this study about?
This study is looking at new ways to treat two types of blood cancer called Hodgkin Lymphoma and Non-Hodgkin Lymphoma. These are cancers that affect the body's immune system. This study is specifically for children and young adults up to 18 years old whose cancer has either returned after treatment or hasn't responded to other treatments given.
The researchers are testing two medicines together: relatlimab and nivolumab (which you might also hear called OPDIVO). These medicines work by helping your own immune system fight the cancer. The study has two main parts. The first part is about finding the right and safest dose of these medicines for young people and carefully watching for any side effects. The second part will then look more closely at how well this combination treatment can make the cancer shrink or disappear.
By taking part, you would be helping doctors learn more about these new treatments. This could lead to better ways to help young people with these types of cancer in the future, especially when standard treatments haven't been successful. It's a way to explore new possibilities and understand how these medicines work in younger patients.
Key takeaways
- New study for young people with specific blood cancers.
- Investigating two new medicines: relatlimab and nivolumab.
- Aims to find a safe dose and see if the treatment shrinks cancer.
- For cancers that have returned or not responded to previous treatments.
- Regular health checks and monitoring will be part of participation.
Who may be eligible?
This study is designed for children and young adults. To be considered, you must be 18 years old or younger. There's no minimum age, so very young children might also be able to join.
Both boys and girls are welcome to take part in this study. The most important condition is that you have been diagnosed with either Hodgkin Lymphoma or Non-Hodgkin Lymphoma, and that your cancer has come back after previous treatment, or hasn't responded to the treatments you've had so far.
There will be other detailed medical checks to make sure the study is a good fit for you and safe for you to join. Your doctor or the study team will discuss these with you.
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.
- Am I 18 years old or younger?
- Have I been diagnosed with Hodgkin Lymphoma or Non-Hodgkin Lymphoma?
- Has my cancer come back after previous treatment?
- Has my cancer not responded to treatments I've had so far?
What does participation involve?
If you join this study, you will likely have regular visits to the hospital or clinic to receive the study medicines. These medicines, relatlimab and nivolumab, are given through a drip into your arm.
Throughout the study, you'll have frequent check-ups, blood tests, and scans (like MRI or CT scans) to see how you're responding to the treatment and to monitor for any side effects. The first part of the study will involve closely monitoring how much medicine is in your body at different times. The doctors will also carefully look for any reactions or side effects you might experience to find the safest dose.
The total length of time you'll be on the study will depend on how your body reacts to the treatment and how well it works. There will also be follow-up appointments after you stop the treatment to check on your long-term health and the lasting effects of the medicines.
Potential risks and benefits
Locations (4)
- —UnverifiedNetherlands
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for two types of blood cancer: Hodgkin Lymphoma and Non-Hodgkin Lymphoma.
Who can join this study?
It's for children and young adults (up to 18 years old) whose cancer has come back or hasn't responded to other treatments.
What are relatlimab and nivolumab?
They are new medicines that help your body's immune system fight cancer.
What will happen if I join?
You'll receive the medicines through a drip and have regular check-ups, blood tests, and scans.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, and it won't affect your regular 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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