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 study about?

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.

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.

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.

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.

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 Study?

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 ≥ 2.0×109/L
- Neutrophils (type of white blood cells) ≥ 1.0×109/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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Llebx Uxpmcmcjykdn Mrevhrp Cmyaznr (igpmw	Leiden	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	15.05.2019

Trial locations

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.

Investigated diseases:

Uveal melanoma

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.

Trial ID:

2024-516127-14-01

Trial Phase:

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

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?