AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

(CHOPI) Phase 1b/2 Study Combining Hepatic Percutaneous Perfusion with Ipilimumab plus Nivolumab in advanced Uveal Melanoma.

This research, called CHOPI, is investigating new treatments for people with advanced uveal melanoma, a rare eye cancer that has spread to other parts of the body, particularly the liver. Liver-focused treatments are often needed. The study is combining a procedure called percutaneous hepatic perfusion (PHP), which delivers strong anti-cancer medicine directly to the liver, with two immunotherapy drugs, ipilimumab and nivolumab. These drugs help your body's immune system fight cancer. The first part of the study ensures this combination is safe and practical. The second part compares whether patients receiving the combination of PHP with the two immunotherapy drugs do better than those receiving PHP alone, specifically looking at how long people live without their cancer progressing.

At a glance

Status

Authorised

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Leids Universitair Medisch Centrum (LUMC)

Enrolment target

Start

12 Sep 2024

metastasized melonama uveal

What is this study about?

This clinical trial, called CHOPI, is exploring new ways to treat a specific type of cancer called uveal melanoma, which starts in the eye. When this cancer spreads to other parts of the body, especially the liver, it's considered advanced. The study aims to find better treatments for patients in this situation.

The trial is looking at a combination of treatments. One part is called percutaneous hepatic perfusion (PHP). This is a special procedure where powerful anti-cancer medicines are delivered directly to the liver, where the cancer has often spread. This allows doctors to target the cancer cells in the liver more directly while trying to limit the side effects on the rest of the body. The study combines this PHP procedure with two well-known immunotherapy drugs: ipilimumab and nivolumab. These drugs work by boosting your body's natural immune system, helping it to recognise and fight cancer cells more effectively.

The study has two main parts. The first part (Phase 1b) focuses on safety, making sure this new combination of PHP with ipilimumab and nivolumab is safe for patients and can be given effectively. Once safety is confirmed, the second part (Phase 2) will compare the new combination to PHP treatment on its own. Researchers will be looking to see if patients treated with the combination live longer without their cancer getting worse, and whether their tumors shrink more. They will also look at overall survival.

Key takeaways

Targets advanced uveal melanoma, especially when it has spread to the liver.
Combines liver-focused medicine (PHP) with immune-boosting drugs (ipilimumab, nivolumab).
Aims to check safety first, then compare effectiveness against PHP alone.
Could offer a new treatment option for this challenging cancer.
Participation involves regular check-ups and treatments.

Who may be eligible?

To join this study, participants must be at least 18 years old. People of any gender can take part.

The study is specifically designed for individuals who have uveal melanoma that has spread (metastasized) to other parts of their body, particularly if it has affected their liver.

There will be other specific health requirements and medical evaluations to make sure the treatment is suitable and safe for each person. A doctor involved in the study would discuss all the detailed criteria with potential participants.

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 uveal melanoma?
Has your uveal melanoma spread to other parts of your body, especially your liver?
Are you able to travel to study appointments?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve several visits to the hospital for assessments and treatments. You would receive treatment that includes a liver procedure called percutaneous hepatic perfusion (PHP), alongside infusions of the immunotherapy drugs ipilimumab and nivolumab, if you are in the combination group. If you are in the other group, you would receive PHP alone. The exact schedule of treatments and tests for each participant will be carefully planned and explained by the study team.

Assessments would include regular blood tests, scans (like MRI or CT scans) to check on your cancer, and check-ups with the study doctors. These are done to monitor how your body is responding to the treatment and to keep track of any side effects. You would also have follow-up visits after your main treatment period to see how you are doing over time. The total duration of participation, including follow-up, would be determined by the study protocol and personal factors.

Potential risks and benefits

Participating in this study might offer potential benefits, such as access to new treatments before they are widely available, and your health will be closely monitored. There's a chance the new combination treatment could be more effective at controlling your cancer. However, all medical treatments carry risks. You might experience side effects from the PHP procedure, ipilimumab, or nivolumab, which can range from mild to serious. The study team will explain all known and potential risks in detail. Remember, you can choose 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
Netherlands

Common questions

What is uveal melanoma?

Uveal melanoma is a rare type of cancer that forms in certain cells in the eye, and it can sometimes spread to other parts of the body.

What does 'advanced' mean in this study?

It means the uveal melanoma has spread from the eye to other areas of the body, most commonly the liver.

What is percutaneous hepatic perfusion (PHP)?

PHP is a procedure that delivers strong cancer-fighting medicine directly to the liver while trying to keep it from affecting the rest of the body as much.

How do ipilimumab and nivolumab work?

These are immunotherapy drugs that help your body's own immune system find and fight the cancer cells.

What is the main goal of this study?

The main goal is to see if combining PHP with ipilimumab and nivolumab is safe and more effective at controlling advanced uveal melanoma than PHP alone.