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A study of ipilimumab and nivolumab to observe immune system changes in patients with unresectable stage III or IV melanoma

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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 unresectable stage III–IV melanoma, which is a serious type of skin cancer that cannot be removed by surgery. The purpose of the study is to compare two different ways of giving medication to see how they affect the immune system's response to the cancer. One approach involves using ipilimumab, an immunotherapy drug that helps the body's own defenses fight cancer, alongside nivolumab. In one part of the study, ipilimumab is given through an intradermal injection, which means the medicine is injected just under the surface of the skin, while nivolumab is given through an intravenous infusion, which is a liquid delivered directly into a vein.

The other part of the study uses the standard method where both ipilimumab and nivolumab are given through intravenous infusion. Researchers will look at how these different methods change the tumour microenvironment, which refers to the area immediately surrounding the cancer cells. The study will also monitor the activity of T cells, which are specific white blood cells that play a key role in the body's ability to attack harmful cells, as well as Tregs, a type of cell that can sometimes prevent the immune system from working too strongly against the cancer.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial medication administration
A single dose of ipilimumab (20 mg) is administered through an intradermal injection, which means the medication is injected into the upper layer of the skin.
nivolumab is administered through intravenous infusion, which means the medication is delivered directly into a vein.
Step 2
Blood monitoring
Blood samples are collected to analyze peripheral blood mononuclear cells, which are specific types of white blood cells found in the bloodstream.
The analysis focuses on measuring the frequency and function of T cells, which are immune cells that help the body fight disease, as well as Tregs, which are a specific group of cells that regulate the immune response.
The T cells are checked for systemic activation, which is measured by looking for an increase in a specific marker called ICOS/CD278.
Step 3
Safety monitoring
Any adverse events, which are side effects or unexpected medical occurrences, are recorded and monitored to ensure safety during the treatment process.

Who can join the trial?

13 criteria

You must be 18 years of age or older.
You must have a medical diagnosis of cutaneous melanoma, which is a type of skin cancer, that is either locally advanced, cannot be removed by surgery, or has spread to other parts of the body.
You must provide written and signed informed consent, which means you agree to participate after being told all the details of the study.
You must have a performance status of 0 or 1, meaning you are generally able to carry out most daily activities and are physically quite active.
Your doctor must agree that you are a suitable candidate for anti-PD-1 treatment, which is a type of immunotherapy that helps the immune system fight cancer.
You must have a life expectancy of at least 3 months.
You must have measurable disease, meaning there is at least one area of skin cancer that can be accurately measured using a CT-scan or MRI (special imaging tests used to see inside the body).
You must have adequate bone marrow function, specifically having enough leukocytes (white blood cells that fight infection) and platelets (cells that help the blood clot).
You must have adequate liver function, meaning your levels of bilirubin and liver enzymes like ASAT and ALAT are within safe limits.
You must have adequate kidney function, measured by your creatinine clearance, which shows how well your kidneys filter waste from your blood.
You must have adequate blood protein and enzyme levels, including sufficient albumin (a protein in the blood) and LDH (an enzyme related to cell damage).
Women of childbearing potential must use contraception (methods to prevent pregnancy) during the study and for 23 weeks after the last dose of medication.
Men who are sexually active with women of childbearing potential must use contraception during the study and for 7 months after the last dose of medication.

Who cannot join the trial?

22 criteria

You have uveal melanoma (cancer that starts in the eye) or mucosal melanoma (cancer that starts in the linings of the body, such as the mouth or nose).
You have used systemic corticosteroids (steroids taken throughout the body, such as pills or injections) to treat swelling or immune system issues within the last 15 days.
You have used immunosuppressive drugs (medicines that lower the body's ability to fight infection) within the last 30 days, unless it was a one-time low dose or inhaled/topical use.
You have taken specific immunosuppressive medications, such as prednisone or methotrexate, within the last 2 weeks.
You have taken immunostimulatory agents (medicines that stimulate the immune system, like interferons) within the last 6 weeks.
You have a known immunodeficiency (a condition where the immune system is weak or not working correctly), such as having had an organ transplant, having leukemia, HIV, hepatitis B, hepatitis C, or AIDS.
You have had major surgery within the last 4 weeks or have a major surgery planned during the study.
Your laboratory test results (including blood and urine tests) show issues that the doctor believes could make the study unsafe for you.
You have any other medical conditions or metabolic dysfunction (problems with how your body processes energy or chemicals) that could make the study treatment dangerous or affect the results.
You have a history of anaphylactic or hypersensitivity reactions (severe allergic reactions) to certain types of protein-based medicines or the ingredients in the study drugs.
You are currently pregnant or breastfeeding.
You have a history of alcohol or drug abuse within the last year.
You have previously used CTLA-4 inhibitors or anti-PD1 treatments (types of immune system drugs), except for a specific use of nivolumab more than 6 months ago.
You are currently taking part in another study using a new medicine, or you have not recovered from side effects of a previous study drug taken more than 4 weeks ago.
The local doctor decides that you are not a suitable candidate for the study for any reason.
You have had radiotherapy (radiation treatment) on the specific tumor areas being measured within the last 2 weeks, or you have not recovered from toxicities (harmful side effects) caused by radiation.
Your ECG (a test that records the electrical activity of your heart) shows significant problems.
You have had another type of malignancy (cancer) that is currently growing or being treated within the last 5 years, excluding certain skin cancers.
You have an active SARS-CoV-2 (COVID-19) infection.
You have a serious illness that is not cancer which the doctor believes could make the study unsafe.
You have metastasis (cancer that has spread) in your brain or bone marrow (the soft tissue inside bones where blood cells are made) that could make the study unsafe.
You have an active systemic infection (an infection spreading through the whole body) that requires treatment or shows symptoms within the last 2 weeks.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands

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Investigated drugs

Ipilimumab
is a type of immunotherapy that helps the body's immune system recognize and attack cancer cells. In this study, it is being tested as an injection under the skin to see how it works when combined with other treatments.
Nivolumab
is another immunotherapy medication that helps the immune system find and destroy tumor cells. In this trial, it is given through a vein as part of the standard treatment for melanoma.

Ipilimumab

What is already known about the treatment

Ipilimumab - This medication is an immunotherapy drug administered as an injection into the skin. It is already used in medical practice to treat certain types of advanced skin cancer, specifically melanoma. It works by blocking a specific protein on immune cells that acts like a brake, allowing the body's natural immune system to recognize and attack cancer cells more effectively. This substance is classified as an immune checkpoint inhibitor.

Investigated diseases

Melanoma - This is a type of skin cancer that develops from pigment-producing cells called melanocytes. It often begins as a new or changing spot on the skin. As the disease progresses, the abnormal cells can grow deeper into the skin layers. These cells may eventually spread to other parts of the body through the lymphatic system or bloodstream.