Not recruiting

Study on the Safety and Effectiveness of Pembrolizumab, Lenvatinib, and Quavonlimab for Patients with Advanced Melanoma with Brain Metastases

Verified siteRegistered drugNo placebo

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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 treatments for advanced melanoma, a type of skin cancer that has spread to the brain. The study is exploring the safety and effectiveness of different treatment combinations, including the use of pembrolizumab (also known by its code name MK-3475), which is a medication given through an intravenous infusion. Other treatments being tested include lenvatinib, taken as a capsule, and a combination of pembrolizumab and quavonlimab (known as MK-1308A), also given by infusion.

The purpose of the study is to assess how safe these treatments are and how well they work in treating melanoma that has spread to the brain. Participants will receive one or more of these treatments, or a placebo, and their health will be monitored closely throughout the study. The study will look at how the cancer responds to the treatments, including any changes in the size of the tumors, and will also track any side effects experienced by participants.

Participants in the study will undergo regular check-ups and imaging tests, such as MRI scans, to evaluate the progress of the treatment. The study aims to provide valuable information on the potential benefits and risks of these treatment combinations for people with advanced melanoma, particularly those whose cancer has spread to the brain.

The research process

The trial runs in 6 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, you will be informed about the trial's purpose, procedures, and potential risks and benefits. You will be asked to provide informed consent, which means you agree to participate after understanding all the information provided.
Step 2
Initial assessment
An initial assessment will be conducted to confirm eligibility. This includes checking your medical history, current health status, and ensuring you meet the study's inclusion criteria, such as having advanced melanoma with brain metastases.
Step 3
Treatment phase
During the treatment phase, you will receive the study medications. These include pembrolizumab administered as an intravenous infusion and lenvatinib taken orally as capsules. The specific dosage and frequency will be determined by the study protocol and your healthcare provider.
If you are assigned to receive pembrolizumab alone, it will be given as an intravenous infusion. If you are assigned to receive a combination treatment, you may also receive quavonlimab with pembrolizumab as an infusion.
Step 4
Monitoring and follow-up
Throughout the study, regular monitoring will occur to assess your response to the treatment and any side effects. This includes physical exams, blood tests, and imaging studies like MRI to evaluate the size and number of brain metastases.
You will be required to attend scheduled visits for these assessments, and any changes in your health will be closely monitored.
Step 5
End of treatment
At the end of the treatment period, a final assessment will be conducted to evaluate the overall response to the study medications. This will include a review of any side effects experienced and the effectiveness of the treatment in managing your condition.
Step 6
Post-study follow-up
After completing the study, follow-up visits may be scheduled to monitor your long-term health and any lasting effects of the treatment. The duration of this follow-up period will depend on the study protocol and your healthcare provider's recommendations.

Who can join the trial?

7 criteria

The patient has **Stage IV, M1D melanoma**. This means the cancer has spread to other parts of the body, including the brain.
The patient is **neurologically asymptomatic** from brain metastases. This means they do not have symptoms affecting the brain.
The patient has not received **systemic corticosteroid therapy** in the 10 days before starting the study. These are medications that reduce inflammation in the body.
If the patient is male and can produce sperm, they agree to use contraception or abstain from sexual intercourse during the study and for a certain period after the last dose of the study medication.
If the patient is female, they are not pregnant or breastfeeding. They must use a highly effective contraceptive method or abstain from heterosexual intercourse during the study and for a certain period after the last dose of the study medication.
The patient has **adequate organ function**. This means their organs, like the liver and kidneys, are working well enough to participate in the study.
Female patients agree not to breastfeed during the study and for a certain period after the last dose of the study medication.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who have had another type of cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread).
Patients who are pregnant or breastfeeding.
Patients who have had a severe allergic reaction to similar treatments in the past.
Patients who are currently participating in another clinical trial.
Patients with active infections that require treatment.
Patients with certain heart conditions that are not well controlled.
Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body.
Patients who have received certain treatments for their cancer within a specific time frame before the study.
Patients with brain metastases that are causing symptoms or require treatment.

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Verified sites

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

Azienda Ospedaliera Universitaria Senese
Responsive
Siena, Italy
Istituto Europeo Di Oncologia S.r.l.
Responsive
Milan, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer cells. Pembrolizumab targets a specific protein on the surface of cells, which can help your immune system recognize and attack cancer cells more effectively. This medication is used in the trial to see if it can help treat melanoma, a type of skin cancer, either on its own or in combination with other investigational treatments.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently a well-established medication in the field of oncology, particularly in the treatment of various cancers, and is frequently discussed in medical literature. The main therapeutic indication for pembrolizumab in this trial is advanced melanoma with brain metastases, especially in patients who are either resistant to or have not been treated with PD-1 inhibitors. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

Advanced Melanoma with Brain Metastases – This is a type of skin cancer that has spread to the brain. Melanoma originates in the pigment-producing cells of the skin and is known for its aggressive nature. When it advances, it can metastasize, or spread, to other parts of the body, including the brain. Brain metastases occur when cancer cells travel through the bloodstream and form new tumors in the brain. The progression involves the growth of these metastatic tumors, which can affect brain function and cause neurological symptoms. The disease can continue to progress with the development of additional brain lesions and increased tumor size.