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Study on the Effect of Nivolumab and Melphalan in Patients with In-Transit Melanoma Metastases

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What is this trial about?

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

This clinical trial is focused on studying a type of skin cancer known as melanoma, specifically when it spreads to areas between the original tumor and nearby lymph nodes, called in-transit metastases. The study is investigating the effects of a treatment called nivolumab, which is also known by its code name BMS936558 or ABP 206. Nivolumab is a medication that helps the immune system fight cancer cells. The trial will also use a procedure called isolated limb perfusion (ILP), which involves delivering high doses of chemotherapy directly to the limb affected by cancer, in this case using a drug called melphalan.

The purpose of the study is to see if combining ILP with nivolumab can improve the treatment outcomes for patients with in-transit melanoma metastases. Participants in the study will receive either the combination of ILP and nivolumab or ILP with a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo, to ensure unbiased results.

Throughout the study, participants will be monitored for their response to the treatment, including any changes in their cancer and overall health. The main goal is to determine if the combination treatment can lead to a complete response, where the cancer is no longer detectable, three months after treatment. Other aspects being studied include how long patients remain free from cancer progression, their overall survival, and any side effects experienced during the trial. The study will also explore how the treatment affects the immune system's ability to fight cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will have provided written informed consent. This indicates understanding and agreement to participate in the trial.
Eligibility is confirmed based on criteria such as age, diagnosis of in-transit metastases of malignant melanoma, and performance status.
Step 2
Initial assessment
The patient undergoes an initial assessment to measure the disease, ensuring at least one metastasis is 5 mm or larger.
This assessment helps establish a baseline for evaluating treatment effects.
Step 3
Treatment phase
The patient receives treatment with isolated limb perfusion (ILP) using melphalan, a chemotherapy drug.
In addition, the patient is administered nivolumab, a medication given through infusion. This is a solution for infusion known as OPDIVO, with a concentration of 10 mg/mL.
The treatment aims to evaluate if ILP combined with nivolumab induces complete responses in melanoma patients.
Step 4
Monitoring and follow-up
The patient is monitored for a period of 3 months post-treatment to assess the response according to specific criteria.
Primary outcomes include the rate of complete response at 3 months, while secondary outcomes involve survival rates, adverse events, and quality of life assessments.
Step 5
End of trial
The trial is estimated to conclude by June 30, 2027.
Final assessments will be conducted to evaluate the long-term effects and outcomes of the treatment.

Who can join the trial?

5 criteria

Must be a male or female aged above 18 years.
Must provide a signed and dated written informed consent before starting any specific procedures related to the study.
Must have a confirmed diagnosis of in-transit metastases of malignant melanoma. This means that the cancer has spread to areas between the original tumor and nearby lymph nodes. It can be confirmed through tests like a biopsy.
Must have a measurable disease, which means there is at least one tumor that is 5 millimeters or larger that can be measured.
Must have an ECOG performance status of 0-2. This is a scale used to assess how well a person can perform daily activities. A score of 0 means fully active, while 2 means capable of all self-care but unable to carry out any work activities.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than **in-transit metastasis of malignant melanoma**. This means the cancer has spread to areas between the original tumor and nearby lymph nodes.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.
Patients who have any medical condition or are taking any medication that might interfere with the study treatment.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who have participated in another clinical trial recently, which might affect the results of this study.
Patients who are pregnant or breastfeeding, as the study treatment might affect the baby.
Patients who have a known allergy or severe reaction to any of the study medications.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
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Gothenburg, Sweden

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Investigated drugs

Nivolumab
is a medication used in this trial to help the immune system attack cancer cells. It is being tested to see if it can improve the treatment outcomes for patients with melanoma that has spread to nearby areas of the skin.
Melphalan
is a chemotherapy drug used in this trial as part of a procedure called isolated limb perfusion (ILP). This procedure delivers high doses of the drug directly to the limb affected by melanoma, aiming to kill cancer cells while minimizing exposure to the rest of the body.

What is already known about the treatment

Nivolumab
This medication is administered intravenously and is used in the treatment of various cancers, including melanoma. It is currently well-established in medical literature as an immune checkpoint inhibitor. Nivolumab is primarily indicated for the treatment of in-transit metastasis of malignant melanoma. It works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. It belongs to the pharmacological class of monoclonal antibodies.
Melphalan
This medication is administered through isolated limb perfusion, a method that delivers the drug directly to the affected limb. It is used in the treatment of in-transit metastasis of malignant melanoma. Melphalan is an alkylating agent that works by damaging the DNA of cancer cells, preventing them from multiplying. It is classified as a chemotherapy drug.

Investigated diseases

In-transit metastasis of malignant melanoma – This condition occurs when melanoma cancer cells spread from the original tumor site to skin or lymph vessels between the primary tumor and nearby lymph nodes. It is characterized by the appearance of new melanoma lesions on the skin, often forming nodules or bumps. These metastases are typically found in the same limb as the original melanoma. The progression involves the growth and potential spread of these lesions, which can vary in size and number. The condition is a sign of advanced melanoma and indicates that the cancer has begun to spread beyond its initial location.