AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT

This UK-based study, called NEO-CYT, is for adults with a serious type of skin cancer called high-risk melanoma. This is melanoma that doctors believe can be fully removed with an operation. The study wants to find out if giving new combinations of medicines before surgery can improve how well treatment works. These medicines, including nivolumab and ipilimumab (types of immunotherapy), alongside MDNA11 or tocilizumab, aim to help your body's immune system fight the cancer. Researchers hope that by treating the cancer before surgery, they can shrink it and reduce the chance of it returning in the future. This is an early-stage study, meaning it's one of the first times these specific combinations are being tested in people with this condition.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Fondazione Melanoma Onlus

Enrolment target

Start

15 Sep 2025

High-Risk Surgically Resectable Melanoma

What is this study about?

This study, known as NEO-CYT, is exploring new ways to treat high-risk melanoma, a serious form of skin cancer that can be removed with an operation. The main goal is to see if giving a combination of different medicines before surgery can improve the chances of a successful outcome. The trial is especially interested in using 'immunotherapy' drugs like nivolumab and ipilimumab, which work by boosting your body's own defence system (your immune system) to fight cancer cells. These are being tested alongside other drugs called MDNA11 or tocilizumab.

Imagine your body's immune system as an army. Sometimes cancer cells can hide from this army. Immunotherapy drugs help your army find and attack these cancer cells more effectively. By giving these medicines before surgery, doctors hope to shrink the cancer, making the operation potentially more effective, and reducing the risk of the cancer coming back later on.

This is an early-stage study, which means it’s one of the first times these specific combinations of medicines are being looked at in people with this type of melanoma. The researchers want to understand how safe they are and how well they work together. Your participation could help improve future treatments for melanoma patients.

Key takeaways

The study is for adults with high-risk melanoma that can be surgically removed.
It tests new combinations of immunotherapy medicines given before surgery.
The goal is to shrink the cancer and reduce the chance of it returning.
This is an early-stage study to check safety and effectiveness.
Participation involves receiving study medicines, regular check-ups, and follow-up after surgery.

Who may be eligible?

To be considered for this study, you need to be an adult, aged 18 or older. Both men and women can take part.

The most important medical requirement is that you have been diagnosed with high-risk melanoma. This means your melanoma is considered serious and your doctors believe it can be completely removed using surgery. The study is specifically looking for people in this situation.

There will be other detailed medical checks to make sure the study treatments are safe for you and that you fit all the requirements. Your doctor will be able to discuss these with you thoroughly.

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 18 years old or older?
Do I have high-risk melanoma?
Has my doctor said my melanoma can be removed by surgery?
Am I able to attend hospital appointments regularly?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive specific study medicines before your planned surgery. This would involve regular visits to the clinic for treatments and check-ups. During these visits, doctors would assess your health, check how you're responding to the medicines, and look for any side effects. You might have blood tests, scans, and physical examinations. After your surgery, there would be a follow-up period where your health and cancer status would continue to be monitored. The total length of your involvement in the study, including treatment and follow-up, would be fully explained by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving new treatments that are not yet widely available and closely monitored medical care. However, because these are investigational medicines, there are also potential risks, including side effects that are not yet fully known. You might not experience any direct medical benefit from joining. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Italy

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that starts in the cells that give your skin colour.

What does 'high-risk' mean?

High-risk means the melanoma is more likely to spread or come back, so doctors want to treat it very carefully.

What is 'immunotherapy'?

Immunotherapy is a type of treatment that helps your body's own immune system fight the cancer.

Will I still have surgery?

Yes, this study is about giving medicines *before* your planned surgery to remove the melanoma.

Is this a new type of treatment?

Yes, these specific combinations of medicines are being tested to see how well they work together for the first time in this group of patients.