Study on Melphalan, Ipilimumab, and Nivolumab for Patients with Uveal Melanoma Liver Metastases

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What is this study about?

This clinical trial is focused on studying a type of cancer called Uveal Melanoma, which can spread to the liver, known as liver metastases. The study is investigating the effectiveness of a treatment method called Percutaneous Hepatic Perfusion (PHP) combined with two medications, Ipilimumab and Nivolumab, compared to using Ipilimumab and Nivolumab alone. Ipilimumab and Nivolumab are medications that help the immune system fight cancer cells. PHP is a procedure where a high dose of chemotherapy is delivered directly to the liver while the rest of the body is protected from the effects of the drug.

The purpose of this study is to evaluate how well patients with uveal melanoma liver metastases respond to these treatments. Participants will be randomly assigned to receive either the combination of PHP with Ipilimumab and Nivolumab or just Ipilimumab and Nivolumab. The study will monitor the progression of the disease, which means checking if the cancer is growing or spreading, and will also look at the overall health and quality of life of the participants.

Throughout the study, participants will receive regular treatments and check-ups to monitor their health and the effects of the treatment. The study aims to provide valuable information on whether adding PHP to the treatment plan can improve outcomes for patients with this type of cancer. The trial is expected to continue for several years to gather comprehensive data on the effectiveness and safety of the treatments being tested.

1 joining the study

Upon joining the study, the patient must provide signed informed consent.

Eligibility is confirmed through various criteria, including age, performance status, and confirmation of liver metastasis from uveal melanoma.

2 initial assessment

An initial assessment is conducted to establish baseline health status.

This includes a computed tomography (CT) scan to identify measurable disease in the liver.

3 treatment allocation

The patient is randomly assigned to one of two treatment groups.

One group receives percutaneous hepatic perfusion (PHP) combined with ipilimumab and nivolumab, while the other group receives only ipilimumab and nivolumab.

4 treatment administration

The medications ipilimumab and nivolumab are administered as solutions for infusion.

The specific dosage and frequency are determined by the study protocol and medical team.

5 monitoring and follow-up

Regular monitoring is conducted to assess the patient’s response to treatment.

This includes evaluating progression-free survival and other health indicators.

6 completion of study

The study is estimated to conclude by December 31, 2028.

Final assessments are conducted to evaluate the overall outcomes and any long-term effects of the treatment.

Who Can Join the Study?

The patient must be at least 18 years old.
Male patients who can have children must agree to use a reliable method of birth control from the start of the study treatment until 150 days after the last dose. Choosing not to have sex is acceptable if it is the usual lifestyle and preferred method of birth control for the patient.
The patient must sign a document agreeing to participate in the study, known as an informed consent.
The patient must have an ECOG performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
The patient must have liver metastasis of uveal melanoma confirmed by a test called histology or cytology, which examines cells or tissues under a microscope.
The patient must have a measurable disease in the liver, identified by a computed tomography (CT) scan according to specific guidelines called RECIST 1.1, with at least one target area in the liver.
The patient must not have had previous treatment for uveal melanoma metastases, except if they have shown disease progression after certain treatments like tebentafusp, surgery, or specific procedures like radiofrequency ablation or stereotactic body radiation therapy.
The patient must be considered suitable for a procedure called percutaneous hepatic perfusion, which is a method to deliver high doses of chemotherapy directly to the liver.
Female patients who can have children must have a negative pregnancy test within 72 hours before receiving the first treatment. If the urine test is positive or unclear, a blood test will be needed.
Female patients who can have children must agree to use a reliable method of birth control during the study and for 150 days after the last dose of study medication. Choosing not to have sex is acceptable if it is the usual lifestyle and preferred method of birth control for the patient.

Who Cannot Join the Study?

Patients who have a different type of cancer than uveal melanoma liver metastases. This means the cancer has spread to the liver from the eye.
Patients who are not within the specified age range for the study.
Patients who belong to a vulnerable population, which means they might need special protection or care.
Patients who are not eligible for the specific treatment groups being studied.
Patients who have any other medical conditions or factors that the study doctors think might make it unsafe for them to participate.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

Site Name	City	Country
Region Oestergoetland	Linkoping	Sweden
Region Vaesterbotten	Umea	Sweden
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Uylajae Uvilkaqund Hiajvxcc	Uppsala	Sweden

Trial status

Country	Status	Recruitment Start
Norway	Recruiting	01.04.2024
Sweden	Recruiting	01.04.2024

Trial locations

Investigated drugs:

Ipilimumab is a medication used in cancer treatment. It works by helping the immune system attack cancer cells. In this trial, it is used to treat patients with uveal melanoma that has spread to the liver.

Nivolumab is another medication that helps the immune system fight cancer. It is often used in combination with other treatments to improve their effectiveness. In this trial, it is used alongside ipilimumab to treat liver metastases in patients with uveal melanoma.

Percutaneous Hepatic Perfusion (PHP) is a procedure used to deliver high doses of chemotherapy directly to the liver. This method aims to target liver tumors more effectively while minimizing exposure to the rest of the body. In this trial, PHP is combined with ipilimumab and nivolumab to evaluate its effectiveness in treating liver metastases from uveal melanoma.

Uveal Melanoma Liver Metastases – This condition occurs when cancer that originated in the uveal tract of the eye spreads to the liver. Uveal melanoma is a type of eye cancer that can metastasize, or spread, to other parts of the body, with the liver being a common site. The progression involves the growth of cancerous cells in the liver, which can lead to liver dysfunction and other complications. As the disease advances, patients may experience symptoms related to liver involvement, such as abdominal pain or jaundice. The spread of melanoma to the liver can significantly impact the patient’s overall health and quality of life. Monitoring and managing the progression of liver metastases is crucial in the care of individuals with this condition.

Trial ID:

2023-508156-20-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Melphalan, Ipilimumab, and Nivolumab for Patients with Uveal Melanoma Liver Metastases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?