Changes in the tumour microenvironment after intravenous or intradermal administration of anti-CTLA-4 in combination with anti-PD1 treatment in patients with melanoma
This study is for people with advanced melanoma that can't be removed by surgery. It's investigating two existing anti-cancer drugs, YERVOY and an anti-PD1 treatment, when used together. The main goal is to understand how this combination affects important immune cells in the body, specifically T-cells. Researchers will compare giving YERVOY directly into the skin versus into a vein, alongside the anti-PD1 treatment. They will measure changes in these immune cells before and after treatment to see how active they become. The study also carefully tracks any side effects to make sure the treatments are as safe as possible. This research helps us learn more about how these drugs work to fight melanoma.
At a glance
What is this study about?
This research study is looking at new ways to treat advanced melanoma, a type of skin cancer that has spread and cannot be surgically removed. The study focuses on combining two types of modern anti-cancer drugs: YERVOY (which is a drug called anti-CTLA-4) and another drug known as anti-PD1 treatment. These drugs are designed to help your body's own immune system fight cancer more effectively.
The main aim of this study is to understand how combining these two drugs affects special immune cells called T-cells. T-cells are like soldiers in your immune system, and their job is to recognise and destroy abnormal cells, including cancer cells. The researchers will be looking very closely at how the number and activity of these T-cells change in patients before and after they receive the treatment. They are particularly interested in whether giving YERVOY directly into the skin (what they call intradermal administration) works differently or potentially better than giving it into a vein (intravenous administration) when combined with the anti-PD1 drug.
By carefully studying these immune changes, and also keeping a close eye on any side effects, the doctors hope to find out if this combined treatment is safe and how it works to boost the immune system against melanoma. This knowledge could help improve treatments for people with melanoma in the future.
Key takeaways
- This study is for people with advanced melanoma that cannot be removed by surgery.
- It combines two anti-cancer drugs: YERVOY and an anti-PD1 treatment.
- Researchers want to see how these drugs affect your immune system's fighting cells (T-cells).
- They are comparing giving YERVOY into a vein versus directly into the skin.
- The study will carefully check for any side effects, ensuring patient safety.
- The aim is to find better ways to use these treatments against melanoma.
Who may be eligible?
To be able to join this study, you must be 18 years old or older. The study is open to both men and women.
It is specifically for people who have advanced melanoma, meaning the cancer is at stage III or stage IV and cannot be removed by surgery. This means the cancer may have spread to nearby lymph nodes or other parts of the body.
There will be other detailed health checks to make sure the treatment is safe for you and that you will benefit most from taking part. Your doctors will discuss all these criteria 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.
- Are you 18 years old or older?
- Do you have advanced melanoma (Stage III or IV)?
- Has your doctor told you your melanoma cannot be removed by surgery?
- Are you able to attend regular clinic visits for treatment and check-ups?
What does participation involve?
If you decide to take part in this study, you will receive two types of anti-cancer medication: YERVOY and an anti-PD1 treatment. Depending on which group you are assigned to, YERVOY will either be given into a vein (like a drip) or directly into your skin. The anti-PD1 treatment will be given into a vein.
Throughout the study, you will have regular visits to the clinic. These visits will involve blood tests to check your T-cells and overall health, and doctors will carefully monitor you for any side effects. You might also have scans or other tests as needed by the study doctors. The exact number of visits, frequency of medication, and total duration of your participation will be explained in detail by the study team, but it will involve ongoing assessments before, during, and after your treatment.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is advanced melanoma?
Advanced melanoma means that the skin cancer has grown and spread to other parts of your body, and cannot be completely removed by surgery.
What are T-cells?
T-cells are a type of white blood cell, like tiny soldiers in your immune system, that help find and destroy unhealthy cells, including cancer cells.
What's the difference between giving YERVOY into a vein or into the skin?
Giving YERVOY into a vein means it's delivered through a drip, while giving it into the skin means it's injected just under the surface, similar to some vaccinations.
Why are researchers looking at the immune system?
By understanding how these drugs affect your immune system, particularly T-cells, researchers hope to find better ways to empower your body to fight the cancer itself.
Will I know if I'm getting YERVOY into a vein or skin?
Yes, if you join the study, the research team will explain which treatment approach you will receive.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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