AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Neoadjuvant nivolumab and ipilimumab for patients with high-risk uveal melanoma

This study is exploring a new way to treat high-risk uveal melanoma, a rare and serious type of cancer that starts in the eye. Researchers are testing a combination of two medicines, nivolumab and ipilimumab, which are types of immunotherapy. Immunotherapy helps your own body's immune system fight cancer. In this study, the medicines are given before surgery to remove the cancer. The main goal is to understand if this treatment is safe and if it can reduce the chance of the cancer spreading or coming back later. This is an early-stage study, meaning doctors are carefully watching how patients respond and if there are any side effects. It's open to adults aged 18 and over, of any gender, who have this specific type of high-risk eye cancer.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Region Hovedstaden

Enrolment target

Start

04 Feb 2026

Uveal melanoma

What is this study about?

Uveal melanoma is a rare type of cancer that begins in the eye. When it's considered 'high-risk,' it means there's a greater chance of the cancer spreading to other parts of the body, which can be very serious. Currently, surgery to remove the cancer is the main treatment. However, doctors are always looking for better ways to prevent the cancer from returning or spreading after surgery.

This study is investigating a new approach using two medicines called nivolumab and ipilimumab. These aren't like traditional chemotherapy; they work by boosting your body's natural defence system, called the immune system, to fight the cancer more effectively. Giving these medicines *before* surgery is known as 'neoadjuvant' treatment. The idea is that by shrinking or weakening the cancer before it's removed, it might reduce the risk of it coming back later on.

This is an early-stage study, sometimes called a Phase I trial. This means the doctors are mainly focused on finding out if the treatment is safe for people with uveal melanoma and what the best dose might be. They will also be looking closely to see if there are any early signs that the treatment is helpful in preventing the cancer from spreading. The information gathered from studies like this is really important for developing new and better treatments for future patients.

Key takeaways

The study is for high-risk uveal melanoma, a type of eye cancer.
It tests two immunotherapy drugs (nivolumab and ipilimumab) before surgery.
The goal is to see if this treatment is safe and helps prevent cancer spread.
This is an early-stage study focusing on safety and initial effectiveness.
It's open to adults aged 18 and over, of any gender.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old, and your gender doesn't matter. The most important thing is that you have been diagnosed with a specific type of eye cancer called high-risk uveal melanoma. The doctors will have special tests to confirm this specific diagnosis.

There will also be other medical checks to make sure this study is right for you and that taking part would be safe. These might include reviewing your general health, other medical conditions you have, and any other medications you are taking. All these checks are put in place to protect your safety and to make sure the study results are clear.

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?
Have you been diagnosed with high-risk uveal melanoma?
Are you generally healthy enough to receive study treatment?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medication (nivolumab and ipilimumab) before your surgery. This would involve regular visits to the hospital for infusions of the medications, likely over several weeks. You would also have frequent check-ups, blood tests, and scans to monitor your health, how you're responding to the treatment, and to look for any side effects. After your surgery, you would continue to have follow-up appointments and tests for a period of time to see how you are doing in the long term. The total duration of your involvement could extend over many months or even a few years, depending on the study's follow-up plan.

Potential risks and benefits

Potential benefits of taking part include receiving a new treatment that might help reduce the risk of your cancer spreading. You would also be closely monitored by a team of cancer specialists throughout the study. However, there are potential risks, as these medications can have side effects, which can vary from mild to more serious; the study team will explain these in detail. It’s important to remember that this is a research study, and there's no guarantee the treatment will work for everyone or that you won't experience side effects. You are always free to withdraw from the study at any time, for any reason, without affecting your standard 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
Denmark

Common questions

What is uveal melanoma?

It's a rare type of cancer that forms in the eye, specifically in the part called the uvea.

What are nivolumab and ipilimumab?

These are special medicines called immunotherapies that help your body's own immune system fight cancer.

What does 'neoadjuvant' mean?

It means the treatment is given before the main surgery to remove the cancer.

Is this a new treatment?

Yes, this specific combination given before surgery for uveal melanoma is being studied to understand its effects better.

Will I still need surgery if I join this study?

Yes, the study treatment is given *before* surgery, which remains an important part of treatment for this cancer.