Metro-PD1-1708: a phase I/II trial evaluating anti-PD1 (Nivolumab) in combination with metronomic chemotherapy in children and teenagers with refractory /relapsing solid tumors
This study is for children and teenagers who have solid cancers that are growing or have returned after previous treatments. Researchers are testing a new approach that combines a medicine called Nivolumab, which helps the body's immune system fight cancer, with a type of chemotherapy that's given at lower, more frequent doses (metronomic chemotherapy). The main goals are to find a safe dose and see how well this combination works against the cancer. They will also look at any side effects and how it affects the patient's quality of life. This is a multi-stage study, starting with checking for safety and then looking at how long patients live without their cancer getting worse.
At a glance
What is this study about?
This clinical trial, called Metro-PD1-1708, is exploring new treatment options for young people with solid tumours. These are cancers that form a lump, and in this study, they are either growing despite previous treatment or have returned after being treated. When standard treatments haven't worked, doctors are always looking for new and better ways to help.
The study combines two types of treatment: Nivolumab and metronomic chemotherapy. Nivolumab is an immunotherapy drug. This means it works by helping your body's own immune system recognise and fight the cancer cells. Metronomic chemotherapy is a way of giving chemotherapy drugs (like Capecitabine, Cyclophosphamide, and Vinblastine) in smaller, more regular doses, rather than larger, spaced-out doses. The idea is that these smaller, more frequent doses might have fewer side effects while still being effective against the cancer.
This trial has two main parts. The first part focuses on safety, to find the right dose of Nivolumab to use with the chemotherapy, and to understand any side effects. Once a safe dose is found, the second part will look at how well the treatment helps control the cancer and for how long. Researchers will also monitor how patients feel generally and their quality of life throughout the study.
Key takeaways
- Tests new cancer treatments for children and teenagers.
- Combines immunotherapy (Nivolumab) with milder chemotherapy.
- Aims to find safe doses and see how well it controls cancer.
- Also monitors side effects and quality of life.
- For solid tumours that haven't responded or have returned.
- Open to patients aged 18 and over, both male and female.
Who may be eligible?
This study is looking for young people aged 18 years and above. There is no upper age limit mentioned, so adults of any age might be considered if they meet all other criteria. Both male and female patients are welcome to take part.
To be considered, you must have a solid tumour that is either growing or has come back after previous treatment. This means the cancer has not responded well to treatments you've already had, or it has returned. Doctors will check many other factors, such as your general health and specific details about your cancer, to see if this study is suitable for you.
It's important to remember that joining a clinical trial is a big decision, and not everyone will be able to take part. Your doctor will be able to explain all the requirements and help you understand if this study might be a good option for your specific 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.
- Am I aged 18 years or older?
- Do I have a solid cancer that is growing or has come back after treatment?
- Am I willing to have regular hospital visits for treatment and check-ups?
- Am I happy to complete questionnaires about my well-being?
What does participation involve?
If you take part in this study, you will receive a combination of Nivolumab and metronomic chemotherapy, which involves several different drugs. The schedule for these drugs will be carefully explained by the study team. You will have regular visits to the hospital or clinic to receive your treatments and for health checks. During these visits, doctors will closely monitor your health, look for any side effects, and assess how the treatment is affecting your cancer. This will involve blood tests, scans, and other medical examinations.
In the first phase of the study, the focus will be on finding the safest dose of the drugs, so you'll be closely watched for any side effects, especially during the first two months. Throughout the study, your progress will be tracked, and doctors will assess how long the cancer stays stable or shrinks. We will also ask you to complete questionnaires about your quality of life, using a tool called KINDL-R. This helps us understand how the treatment is affecting your daily life and well-being. The study will involve follow-up appointments for up to three years after the last patient has joined.
Potential risks and benefits
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Common questions
What is a 'solid tumour'?
A solid tumour is a mass of abnormal cells that forms a lump, as opposed to cancers like leukaemia which affect blood cells.
What does 'refractory' or 'relapsing' mean?
'Refractory' means the cancer hasn't responded to previous treatments. 'Relapsing' means the cancer has returned after being treated.
What is immunotherapy like Nivolumab?
Immunotherapy helps your body's own immune system recognise and fight cancer cells more effectively.
What is 'metronomic chemotherapy'?
This is a way of giving chemotherapy drugs in smaller doses more frequently, rather than larger doses spread out over time.
Will I know if the treatment is working?
The study team will perform regular scans and tests to check how your cancer is responding to the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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