RecruitingNAINTERVENTIONAL

Immunological Functionnal Test Validation to Predict Melanoma Metastatic Patient Response to Checkpoint Inhibitors

This research is exploring how a type of advanced skin cancer, called melanoma, responds to new treatments called checkpoint inhibitors. Specifically, it's looking at drugs like nivolumab and ipilimumab, which are known to boost the immune system to fight cancer. While these treatments can be very effective, they can also cause serious side effects because they make the immune system more active. The study aims to identify specific chemical signals in the body, called cytokines, that might predict whether a patient will respond well to the treatment or experience side effects. By understanding these signals, doctors hope to better balance the benefits and risks of these powerful cancer medicines, making treatment safer and more effective for future patients.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

31 Jan 2023

Estimated completion

01 Jun 2027

Melanoma (Skin)

What is this study about?

This study is looking into a new way to understand how advanced skin cancer (melanoma) patients respond to modern treatments called 'checkpoint inhibitors'. You might have heard of drugs like nivolumab and ipilimumab. These are special medicines that essentially take the 'brakes' off your immune system, helping your body recognise and fight cancer cells more effectively. Combining these two drugs can be very powerful against advanced melanoma because they work together to boost your immune response.

However, because these treatments supercharge your immune system, they can sometimes cause serious side effects. These side effects happen when the ramped-up immune system mistakenly attacks healthy parts of your body. Doctors are looking for ways to predict who will benefit most from these treatments and who might be at higher risk of these side effects. This knowledge would allow them to tailor treatment plans better, aiming for the best possible outcome with the fewest problems.

Researchers previously found that melanoma patients who respond well to these treatments tend to have certain immune chemicals, called cytokines, at higher levels. They also noticed that other specific cytokines might increase if a patient develops severe side effects. This study is an original approach aiming to examine these immune chemicals at the start of treatment and as it progresses, to see if changes in their levels can act as early warning signs or indicators of success. The goal is to find a balance where the treatment is effective against cancer but doesn't cause too many problems for the patient.

Key takeaways

This study helps understand advanced melanoma treatment.
It looks at immune system chemicals (cytokines) to predict treatment success and side effects.
It's for adults with advanced melanoma starting specific immune-boosting drugs.
Participation involves blood tests during regular clinic visits.
The goal is to improve future patient care by predicting treatment responses.

Who may be eligible?

To take part in this study, you need to be an adult with a confirmed diagnosis of advanced melanoma skin cancer. This means your cancer has either spread or can't be removed by surgery. Your doctor will use specific scans to confirm that your cancer fits the study’s criteria, often called RECIST 1.1.

This study is for people who are starting their very first treatment with checkpoint inhibitor medications like nivolumab and ipilimumab. It’s important that you haven't received these types of treatments before.

There are also some reasons why you wouldn't be able to join. For example, if your melanoma started in your eye or in certain inner linings of the body (like your mouth or nose), this study wouldn't be suitable. You also can't have brain tumours that are causing symptoms, or be taking other medicines that suppress your immune system.

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 an adult aged 18 or over?
Do you have advanced melanoma (skin cancer that has spread or can't be removed)?
Are you about to start your first treatment with nivolumab and ipilimumab combination therapy?
Do you *not* have melanoma in your eye or certain internal linings of your body?
Do you *not* have active brain tumours causing symptoms or take immune-suppressing medicines?

Answer every question to see your result.

What does participation involve?

This study focuses on understanding how your immune system responds to your cancer treatment. If you decide to take part, you wouldn't be given new medicines but rather have certain tests done alongside your usual treatment. This mainly involves providing blood samples at the beginning of your treatment and regularly during your ongoing combined immunotherapy (nivolumab and ipilimumab). These blood samples will be used to measure specific immune chemicals called cytokines. This is a "functional test" meaning they will look at how these chemicals are working. There won't be extra hospital visits purely for the study; samples would be collected during your routine clinic appointments. The total duration would be for the period where you are receiving the combined immunotherapy and subsequent follow-up, which your doctor will discuss with you.

Potential risks and benefits

The main benefit of taking part in this study is contributing to a better understanding of how advanced melanoma treatments work, which could help future patients. For you directly, there's no guarantee of personal benefit, as it's an observational study focused on testing. The primary risks involve the usual discomfort and potential for bruising from blood draws. You are free to withdraw from the study at any time without affecting your medical care.

Locations (3)

CHU de Nice - Hôpital de l'Archet
Verified postcode
Nice, France· Recruiting
CHU de Montpellier
Verified postcode
Montpellier, France· Recruiting
CHRU de Lille
Verified postcode
Lille, France· Not yet recruiting

Common questions

What are 'checkpoint inhibitors'?

Checkpoint inhibitors are a type of cancer medicine that helps your body's immune system recognise and fight cancer cells.

What is melanoma?

Melanoma is a serious type of skin cancer. In this study, we're looking at advanced melanoma, meaning it has spread or is difficult to treat.

What are cytokines and why are they important?

Cytokines are small proteins that act as messengers in your immune system. Researchers believe they might help predict how well your cancer treatment works and if side effects will occur.

Will I receive new treatment in this study?

No, you won't receive new treatment. The study observes how your body responds to standard treatments you're already receiving for melanoma.

Will this study change my current cancer care?

No, taking part in this study will not change how your doctors manage your cancer or the treatment you receive.

How to find out more

Montaudie Henri, PhD

montaudie.h@chu-nice.fr 33492036083 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.