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Study on Pembrolizumab for Patients with High-Risk Melanoma Without Signs of Metastasis

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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 called melanoma, specifically in patients who have a high risk of the cancer spreading but do not yet show signs of it spreading to other parts of the body. The treatment being tested in this study is called pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is a type of medicine that helps the immune system fight cancer cells and is given to patients through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of this study is to see how effective pembrolizumab is in treating high-risk melanoma before any surgery is done to remove the cancer. This approach is known as "neoadjuvant" treatment, which means the treatment is given before the main treatment, usually surgery, to help shrink the tumor and make it easier to remove. The study will monitor how well the treatment works by checking if the cancer has spread to nearby lymph nodes, which are small glands that help fight infection and are often the first place cancer spreads.

Participants in the study will receive pembrolizumab over a period of time, and doctors will perform regular check-ups and tests to see how the cancer responds to the treatment. The study will also look at the overall health and quality of life of the participants during the treatment. This research aims to provide more information on how pembrolizumab can be used effectively in treating high-risk melanoma and improve outcomes for patients with this type of 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
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history, physical examination, and necessary laboratory tests to ensure adequate organ function.
A sentinel lymph node biopsy is performed to check for any signs of melanoma spread.
Step 2
Treatment administration
The treatment involves the administration of pembrolizumab, a medication given through an intravenous infusion. This is a solution that is slowly introduced into the bloodstream through a vein.
The dosage is 25 mg/mL, and the frequency and duration of administration are determined by the study protocol.
Step 3
Monitoring and follow-up
Regular monitoring is conducted to assess the response to treatment. This includes clinical examinations, blood tests, and imaging studies as needed.
The primary goal is to evaluate the absence of melanoma in the sentinel node after treatment.
Step 4
Evaluation of outcomes
The study measures several outcomes, including the rate of negative sentinel node procedures, recurrence-free survival, and overall survival.
Safety is assessed through clinical examinations and analysis of any side effects experienced during the trial.
Step 5
Quality of life assessment
Health-related quality of life is evaluated using a questionnaire designed to understand the impact of treatment on daily living.
This assessment helps in understanding the overall well-being of participants during the trial.

Who can join the trial?

10 criteria

Must be at least 18 years old on the day of signing the consent form.
Must be able to provide written consent to participate in the study, which means agreeing to follow the study's rules and restrictions.
Must have a confirmed diagnosis of high-risk primary cutaneous melanoma. This is a type of skin cancer that is considered high risk based on specific medical tests and stages.
Must be able to undergo a procedure called sentinel lymph node biopsy, which checks if cancer has spread to the lymph nodes.
Must not have any signs of cancer spreading to other parts of the body, as shown by specific medical scans and exams.
Must not have received any previous treatment that affects the whole body for melanoma.
Must have an ECOG Performance Status of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities.
Must have normal organ function, which includes specific levels of blood cells and chemicals in the body, checked within 7 days before starting the study treatment.
Women who can have children must have a negative pregnancy test before starting treatment and agree to use effective birth control during the study and for 16 weeks after the last treatment. Women must not be breastfeeding.
Men with partners who can have children must agree to use effective birth control starting 14 days before the first treatment, during the study, and for 16 weeks after the last treatment, or have had a vasectomy.

Who cannot join the trial?

4 criteria

Patients with any other type of cancer besides melanoma cannot participate. Melanoma is a type of skin cancer.
Patients who have signs of cancer spreading to other parts of the body, known as metastasis, are not eligible. Metastasis means the cancer has moved beyond its original location.
Patients who are not within the specified age range for the study cannot join. The study is open to certain age groups only.
Patients who are part of a vulnerable population, meaning they might need special protection or care, are not allowed to participate.

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Vrije Universiteit Brussel
Jette, Belgium

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Investigated drugs

Pembrolizumab is a medication used in this clinical trial to treat patients with high-risk melanoma. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. In this trial, pembrolizumab is given to patients before surgery to see if it can reduce the size of the melanoma and prevent the cancer from spreading.

Pembrolizumab

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently well-established in medical literature as an immunotherapy for various cancers, including melanoma. The main therapeutic indication for pembrolizumab in this trial is high-risk melanoma without signs of metastasis. It works by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. Pembrolizumab is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that begins in the cells responsible for producing melanin, the pigment that gives skin its color. It typically appears as a new spot on the skin or a change in an existing mole, often with irregular borders and multiple colors. Melanoma can grow quickly and has the potential to spread to other parts of the body if not detected early. It is more common in areas of the skin that have been exposed to the sun, but it can also occur in places not typically exposed. The progression of melanoma is categorized by stages, with early stages being confined to the skin and later stages involving spread to lymph nodes or other organs. Regular skin checks and awareness of changes in skin appearance are important for early detection.