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Study on the Effectiveness of Pembrolizumab and Ipilimumab in Melanoma Patients with Brain Metastases Requiring Steroid Treatment

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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 the effects of immunotherapy in patients with advanced melanoma that has spread to the brain. The study involves the use of medications known as anti-PD-1 antibodies and anti-CTLA-4 antibodies. These medications are designed to help the immune system fight cancer cells. The specific drugs being tested include pembrolizumab (also known as Keytruda), ipilimumab (also known as Yervoy), and nivolumab (also known as Opdivo). Some patients may receive a combination of these drugs, while others may receive a placebo.

The purpose of the study is to evaluate how effective these treatments are for patients who need steroid medication due to brain metastases. The trial will observe patients over a period to see how well the treatments work in controlling the cancer and improving survival rates. Participants will receive the medications through an intravenous infusion, which means the drugs are given directly into a vein. The study will monitor the patients' health and response to the treatment over time.

Throughout the study, researchers will look at various outcomes, such as how long patients live without the cancer getting worse and the overall survival rate. They will also assess the response of the cancer both inside and outside the brain. The study aims to provide valuable information on the effectiveness of these immunotherapy treatments for patients with melanoma that has spread to the brain.

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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of metastatic melanoma with brain metastasis and the need for systemic steroid treatment.
Eligibility criteria include being 18 years or older, having a performance status of 0-2, and the ability to undergo an MRI with a contrast agent.
Step 2
Treatment initiation
The treatment phase begins with the administration of immunotherapy drugs. These may include pembrolizumab (Keytruda), ipilimumab (Yervoy), and nivolumab (Opdivo), which are given intravenously.
The specific combination and dosage depend on individual treatment plans, which are determined by the study protocol.
Step 3
Ongoing treatment and monitoring
Regular monitoring is conducted to assess the response to treatment. This includes imaging tests to evaluate the size and number of brain metastases.
Blood tests and other assessments are performed to monitor overall health and detect any side effects from the treatment.
Step 4
Progress evaluation
The primary goal is to achieve a 6-month progression-free survival rate and a 6-month overall survival rate.
Secondary goals include evaluating overall survival, response rates, and clinical benefits, both intracranially and extracranially.
Step 5
Completion and follow-up
Upon completion of the treatment phase, follow-up assessments are conducted to monitor long-term outcomes and any late side effects.
The study is expected to continue until December 31, 2029, with ongoing evaluations of treatment efficacy and safety.

Who can join the trial?

8 criteria

Must have a confirmed diagnosis of metastatic melanoma, which means the melanoma has spread to other parts of the body, including the brain.
Must need treatment with steroids (medications that reduce inflammation) due to brain metastasis. This includes taking more than 10 mg of prednisolone daily, more than 1.6 mg of dexamethasone daily, or more than 40 mg of hydrocortisone daily, or an equivalent dose.
Must have at least one measurable tumor or lesion as per specific guidelines called RECIST version 1.1, which are used to assess how tumors respond to treatment.
Must be 18 years of age or older.
Must have a performance status of 0-2, which is a scale that measures how well a person can perform ordinary tasks and carry out daily activities.
Must be able to undergo an MRI (a type of imaging test) with a special dye called gadolinium.
Must have adequate hematological (blood-related) and organ function, meaning the blood and organs are working well enough.
Must have signed a consent form after receiving both oral and written information about the study, indicating they understand and agree to participate.

Who cannot join the trial?

7 criteria

Patients who do not have advanced melanoma. Melanoma is a type of skin cancer, and "advanced" means it has spread to other parts of the body.
Patients who do not have melanoma that has spread to the brain.
Patients who do not need steroid treatment. Steroids are medicines used to reduce inflammation and help with certain symptoms.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not male or female, as the study includes both genders.
Patients who are not considered part of a vulnerable population. This means people who might need extra protection or care.

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Verified sites

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

Aarhus University Hospital
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Aarhus, Denmark
Herlev Hospital
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Herlev, Denmark
Odense University Hospital
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Odense, Denmark

Trial locations

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Investigated drugs

Anti-PD-1 Antibodies
are a type of immunotherapy used to help the body's immune system fight cancer cells. In this trial, they are being tested to see how effective they are in treating melanoma that has spread to the brain. These antibodies work by blocking a specific pathway that cancer cells use to hide from the immune system, allowing the immune system to better recognize and attack the cancer cells.
Anti-CTLA-4 Antibodies
are another form of immunotherapy that can be used in combination with anti-PD-1 antibodies. They help to further enhance the immune system's ability to fight cancer by targeting a different pathway. This combination is being studied to determine if it provides a more effective treatment for melanoma patients with brain metastases who are also receiving steroid treatment.

What is already known about the treatment

Anti-PD-1 Antibodies
These medications are administered intravenously and are currently being studied for their effectiveness in treating advanced melanoma, particularly in patients with brain metastases. They are well-documented in medical literature as a promising treatment option in oncology. The main therapeutic indication is for advanced melanoma, especially in cases where the cancer has spread to the brain. At the molecular level, anti-PD-1 antibodies work by blocking the PD-1 protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. They are classified as immunotherapy agents.
Anti-CTLA-4 Antibodies
This medication is also given intravenously and is used in combination with anti-PD-1 antibodies for treating advanced melanoma with brain metastases. It is recognized in medical literature as a significant advancement in cancer treatment. The primary therapeutic use is for advanced melanoma, particularly when the disease has spread to the brain. The mechanism of action involves inhibiting the CTLA-4 protein on T-cells, enhancing the immune response against cancer cells. It falls under the category of immunotherapy drugs.

Investigated diseases

Advanced Melanoma – This is a type of skin cancer that has spread beyond the original site to other parts of the body, such as the lymph nodes, lungs, liver, brain, or bones. It begins in the melanocytes, which are the cells responsible for producing melanin, the pigment that gives skin its color. As the disease progresses, it can form tumors in distant organs, leading to various symptoms depending on the affected areas. The spread to the brain can cause neurological symptoms, while involvement of other organs may lead to systemic symptoms like fatigue or weight loss. The progression of advanced melanoma can vary, with some patients experiencing rapid changes, while others may have a slower course. The disease is often characterized by its ability to resist traditional treatments, necessitating the exploration of new therapeutic approaches.