RecruitingRare disease

Study of Ipilimumab, Nivolumab and Melphalan combination therapy with hepatic perfusion in patients with advanced uveal melanoma that has spread to other organs

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with uveal melanoma, a rare type of eye cancer that has spread to the liver. The research examines a combination treatment approach using three medications: ipilimumab, nivolumab, and melphalan. The treatment involves a procedure called hepatic percutaneous perfusion, which delivers medication directly to the liver, combined with two drugs that help the immune system fight cancer cells.

The purpose of the study is to determine if combining these treatments is safe and effective for patients with liver metastases from uveal melanoma. The treatment plan includes giving medications through intravenous administration, with some medications being delivered directly to the liver through a special procedure. The study consists of two parts - an initial safety evaluation phase followed by a comparison phase between different treatment combinations.

During the study, patients will receive either the liver perfusion treatment alone or liver perfusion treatment combined with both ipilimumab and nivolumab. The medications ipilimumab and nivolumab are types of immunotherapy that work by helping the body's immune system recognize and attack cancer cells, while melphalan is a chemotherapy drug that directly kills cancer cells.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
You will receive treatment through intravenous administration (delivery of medication directly into your bloodstream) of three medications: ipilimumab, nivolumab, and melphalan.
The treatment involves a procedure called Percutaneous Hepatic Perfusion (PHP), which delivers medication directly to your liver.
Step 2
Treatment monitoring
Regular blood tests will be performed to monitor your health status, including white blood cell count, liver function, and other important indicators.
Your response to treatment will be evaluated using imaging scans to measure any changes in the liver tumors.
Step 3
Follow-up assessments
Your overall health status will be monitored throughout the treatment period.
The medical team will track how well the treatment is working using standard measurement criteria called RECIST 1.1 and iRECIST.
The study will continue monitoring your progress for up to one year to assess the long-term effectiveness of the treatment.
Step 4
Long-term monitoring
Your overall survival and health status will be tracked throughout the study period, which may continue until November 2027.
Regular assessments will continue to evaluate the safety and effectiveness of the treatment combination.

Who can join the trial?

16 criteria

Age must be between 18 and 80 years
Must have good physical condition (WHO Performance Status 0 or 1 - able to perform all or most daily activities)
Must have confirmed liver metastases that cannot be surgically removed, affecting 50% or less of the liver
No previous systemic treatments (such as chemotherapy, vaccines, antibody treatments)
Previous local treatments of metastases are allowed (except chemotherapy procedures), if disease has progressed
Not taking systemic steroids higher than 10mg/day prednisone or equivalent (topical and inhaled steroids are allowed)
Blood test results must meet specific criteria:
- White blood cells ≥ 2.0x109/L
- Neutrophils (type of white blood cells) ≥ 1.0x109/L
- Platelets ≥ 100 x109/L
- Hemoglobin (protein carrying oxygen) ≥ 6.5 mmol/L
- Normal or slightly elevated liver and kidney function tests
- Women who can become pregnant must use reliable contraception
- Men must use contraception as specified in the protocol
- No other severe or uncontrolled medical conditions
- No current or previous cancer in the past 2 years (except for successfully treated skin cancer or cervical cancer in situ)
- Liver blood vessels must be suitable for the procedure

Who cannot join the trial?

14 criteria

History of autoimmune disease (a condition where the immune system attacks healthy cells in the body)
Previous treatment with immune checkpoint inhibitors (medications that help the immune system fight cancer)
Active brain metastases (cancer that has spread to the brain) that are not treated
Serious heart conditions including uncontrolled hypertension (high blood pressure)
Active infections requiring systemic treatment
Pregnant or breastfeeding women
Known allergies to study medications
Major surgery within 4 weeks before starting the study
Participation in another clinical trial within 30 days
Serious mental health conditions that could affect participation
Liver dysfunction or active hepatitis
Active or chronic inflammatory bowel disease (conditions affecting digestive system)
History of organ transplant
Uncontrolled medical conditions that could interfere with treatment

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Responsive
Leids Universitair Medisch Centrum (LUMC)
Leiden, The Netherlands

Trial locations

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Investigated drugs

Ipilimumab is a medication that helps the immune system fight cancer cells. It works by activating the body's immune system to recognize and attack melanoma cells. This medication is commonly used in the treatment of different types of melanoma. Nivolumab is also an immunotherapy medication that works by helping the immune system fight cancer. It blocks certain proteins on cancer cells that can stop the immune system from working properly. When used together with ipilimumab, it can enhance the body's ability to fight melanoma. Hepatic Percutaneous Perfusion (PHP) is a treatment procedure where anti-cancer medications are delivered directly to the liver through blood vessels. This targeted approach allows for higher doses of medication to reach liver tumors while limiting exposure to the rest of the body. It's specifically designed to treat melanoma that has spread to the liver.

What is already known about the treatment

Ipilimumab
An intravenously administered immunotherapy medication that belongs to the class of monoclonal antibodies used in advanced melanoma treatment. It works by targeting and blocking CTLA-4, a protein that normally helps keep immune system T-cells in check, thereby enhancing the body's immune response against cancer cells. This medication is primarily used in the treatment of metastatic melanoma, including uveal melanoma, and has shown significant effectiveness in clinical trials when combined with other immunotherapy agents.
Nivolumab
A prescription immunotherapy drug administered through intravenous infusion that belongs to the PD-1 inhibitor class of medications. It functions by blocking the PD-1 protein on T-cells, which helps the immune system recognize and attack cancer cells more effectively. This medication is commonly used in treating various types of cancer, including melanoma, and has demonstrated improved outcomes when used in combination therapy, particularly for patients with metastatic uveal melanoma.

Investigated diseases

Uveal Melanoma – A cancer that develops in the uvea, which is the middle layer of the eye containing blood vessels, pigment cells, and muscle fibers. This type of eye cancer begins when pigment-producing cells called melanocytes develop mutations and grow uncontrollably. When uveal melanoma spreads (metastasizes), it most commonly affects the liver. The disease typically develops slowly in one eye, and in its early stages, it may not cause any noticeable symptoms. Uveal melanoma is considered a rare form of cancer, occurring less frequently than other types of melanoma.