A phase II, open label, randomised trial of ipilimumab and nivolumab with concurrent intracranial stereotactic radiotherapy versus ipilimumab and nivolumab alone in patients with melanoma brain metastases
This study is for people with melanoma (a type of skin cancer) that has spread to their brain. It will test if adding a special type of radiation therapy to two existing cancer medicines, YERVOY and OPDIVO, works better than taking the medicines alone. Doctors want to find out how many people in each group are still alive after one year and if their brain tumours have grown. They will also look at how these treatments affect other parts of the body, and any side effects like damage to healthy brain tissue from the radiation. The main goal is to improve treatment for melanoma brain metastases.
At a glance
What is this study about?
This research study is about trying to find better ways to treat a type of cancer called melanoma, specifically when it has spread to the brain. When cancer spreads from its original location to other parts of the body, it's called 'metastatic cancer.' In this case, doctors are focusing on 'melanoma brain metastases,' which means the melanoma has travelled to the brain.
The study will look at two medicines, YERVOY and OPDIVO, which are already used to treat certain cancers. These medicines work by helping your body's own immune system fight the cancer. The study wants to see if adding a special type of radiation therapy, called 'stereotactic radiotherapy,' to these two medicines makes the treatment more effective than just using the medicines alone. Stereotactic radiotherapy is a very precise way to deliver high doses of radiation to a small area, like a brain tumour, while trying to protect the surrounding healthy brain tissue.
The main thing the doctors want to understand is how many patients in each group (those getting medicines plus radiation, and those getting medicines only) are still alive after one year, and if the cause of death is related to their brain tumours. They will also closely monitor how well the treatments shrink or control the tumours in the brain and in other parts of the body. By comparing these two approaches, the researchers hope to find a better treatment plan for people facing this challenging condition. This helps us learn more about the best ways to fight melanoma that has spread to the brain.
Key takeaways
- This study is for people with melanoma that has spread to the brain.
- It compares two cancer drugs (YERVOY and OPDIVO) with or without special radiation.
- The main aim is to see how many people are alive after one year and how tumours respond.
- Participation involves regular treatments, scans, and health checks.
- You might receive a new treatment, but there are potential side effects.
- You have the right to leave the study at any time.
Who may be eligible?
This study is open to both men and women. You must be at least 18 years old to take part; there is no upper age limit.
To be considered for this study, you must have been diagnosed with melanoma that has spread to your brain. The doctors will check your medical history and current health to make sure this study is right for you and that taking part would be safe.
If you have other serious health conditions or are currently on certain other treatments, you might not be able to join. The study team will review all your medical information carefully to see if you meet all the requirements.
- Are you 18 years old or older?
- Have you been diagnosed with melanoma that has spread to your brain?
- Are you able to have regular hospital visits and medical tests?
- Have you discussed this study with your doctor?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would be put into one of two groups by chance (like flipping a coin). One group will receive two medicines, YERVOY and OPDIVO, as infusions (given directly into your vein). The other group will receive these same two medicines, plus they will have a special type of radiation treatment to their brain tumours. Both groups will have regular hospital visits for their treatments, check-ups, and scans to monitor how the cancer is responding and to check for any side effects.
Over time, you'll have various tests, including imaging scans of your brain and other parts of your body, to see if the treatments are working. These scans help doctors measure how much your tumours have shrunk or if they have grown. You will also have blood tests and physical examinations.
There will be follow-up appointments even after your main treatment period finishes, to continue monitoring your health and the long-term effects of the treatment. The total length of your participation, including follow-up, will depend on your individual response and how well you are doing, but could last for several years.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What is melanoma brain metastases?
It means you have melanoma, a type of skin cancer, that has spread from where it started to your brain.
What are YERVOY and OPDIVO?
These are medicines that help your body's immune system fight cancer. They are given as an infusion into a vein.
What is stereotactic radiotherapy?
It's a very precise type of radiation treatment used to target and treat tumours, like those in the brain, while trying to protect healthy tissue.
Why are they doing this study?
Doctors want to find out if combining YERVOY and OPDIVO with this special radiation therapy is a better treatment for melanoma that has spread to the brain, compared to just using the medicines alone.
Will I definitely get the radiation therapy?
No, you will be randomly assigned to one of two groups. One group gets the medicines plus radiation, and the other group gets only the medicines.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.