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RecruitingTherapeutic exploratory (Phase II)Interventional

Efficacy of immunotherapy in melanoma patients with brain metastases treated with steroids. The MEMBRAINS trial

Melanoma is a type of skin cancer that can sometimes spread to other areas of the body, including the brain. When cancer reaches the brain, doctors often prescribe steroid medicines to reduce swelling and ease symptoms. However, steroids can calm down the immune system, leaving doctors unsure how well newer treatments like immunotherapy work alongside them. The MEMBRAINS clinical trial is testing cancer treatments, including immunotherapy and targeted drugs, in people with advanced melanoma who have brain tumours and are taking steroids. The study aims to see whether these medicines can safely shrink tumours both inside the brain and across the rest of the body. By tracking patients over six months and longer, researchers hope to find the best care plans for people living with this condition.

At a glance

Status
Recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Region Hovedstaden
Enrolment target
41
Start
26 Aug 2024

What is this study about?

Melanoma is an aggressive form of skin cancer. In its advanced stages, it can spread to other organs. When melanoma spreads to the brain, it can cause fluid build-up and swelling. Doctors frequently treat this swelling with steroid medicines, which are very helpful for relieving headaches, sickness, and other neurological symptoms.

In recent years, immunotherapy has changed how melanoma is treated by helping the body's own immune system find and attack cancer cells. However, because steroids work by dampening the immune system, people taking them were often left out of earlier clinical trials. As a result, doctors do not yet have clear evidence on how effective immunotherapy is when taken alongside steroids.

The MEMBRAINS trial was designed to answer this important question. It tests several established cancer drugs—including immunotherapies given by a drip and targeted tablets—in people who have melanoma in the brain and require steroids. The researchers want to measure how many patients see their tumours shrink or stay stable at six months and beyond.

Taking part in this study helps researchers gather crucial safety and response data. The results could help NHS doctors make more informed treatment choices for people facing advanced melanoma in the future.

Key takeaways

  • The MEMBRAINS study tests cancer treatments in people with melanoma that has spread to the brain.
  • It specifically looks at patients who are taking steroid medicines for brain swelling.
  • The main goal is to measure tumour control and survival after six months of treatment.
  • Participants receive regular monitoring with MRI and CT scans.
  • Taking part is voluntary, and you can withdraw at any time without losing NHS care.

Who may be eligible?

This trial is for adults aged 18 and over who have been diagnosed with advanced melanoma that has spread to the brain. To be considered, patients usually need to be taking steroid tablets or injections to help manage swelling or symptoms caused by the brain tumours.

Participants must be well enough to attend regular hospital appointments and undergo routine health checks. Doctors will check your organ function, such as how well your liver and kidneys are working, using standard blood tests.

You may not be eligible if you have certain other medical conditions, severe active infections, or if your doctor feels that these specific study medicines are not safe for you. Your oncology team can review your medical history to see if the study is a good match.

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.

  1. I am aged 18 or over.
  2. I have been diagnosed with advanced melanoma (skin cancer).
  3. My cancer has spread to my brain.
  4. I am currently taking steroid medication to help manage brain symptoms.
  5. I am well enough to attend hospital visits for treatment and scans.
Answer every question to see your result.

What does participation involve?

Taking part in this trial involves receiving approved melanoma treatments, which may include immunotherapy drips into a vein (such as nivolumab or pembrolizumab) or daily targeted tablets. Treatments are usually given in cycles every few weeks at a hospital clinic.

You will have regular check-ups with your care team. These visits include physical exams, blood tests, and scans. You will have MRI scans of your brain and CT scans of your body to track how the tumours are responding to treatment. The main study period assesses your progress at six months, with follow-up appointments continuing afterwards to monitor your health and wellbeing over the longer term.

Potential risks and benefits

A potential benefit of joining is receiving close, specialised monitoring from a cancer care team, with the hope that the treatment will help shrink or control your tumours. However, there is no guarantee the treatment will work for everyone. Potential risks include side effects from the cancer medications, such as severe tiredness, skin rashes, diarrhoea, or inflammation in other organs. Having regular scans and blood tests can also take up time. Joining the trial is entirely your choice, and you can withdraw at any time without your normal NHS care being affected.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • —
    Unverified
    Denmark

Common questions

Why is this trial focusing on people taking steroids?

Steroids reduce brain swelling, but they also calm the immune system. Doctors need to know whether modern cancer drugs still work well when steroids are being used.

How are the study medicines given?

Depending on the exact treatment plan, medicines are given either as an infusion through a drip in your arm at the hospital or as tablets you swallow at home.

Will I have to pay to take part in this trial?

No. In the UK, clinical trial medications and study-related tests are provided free of charge through the hospital.

How often will I need scans?

You will have regular MRI brain scans and body CT scans, usually every few months, to see how your tumours are responding to the treatment.

Can I leave the study if I change my mind?

Yes. You are free to leave the trial at any point. Your doctors will simply discuss standard alternative treatments with you.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Efficacy of immunotherapy in melanoma patients with brain me…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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