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Study of Pembrolizumab for Patients with Stage IIb/c Melanoma

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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 Stage IIb/c melanoma, a type of skin cancer. The treatment being tested is called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is a medication that is given through an infusion, which means it is delivered directly into the bloodstream. The purpose of the study is to understand how well pembrolizumab works in treating patients with this stage of melanoma before they undergo surgery.

Participants in the study will receive one dose of pembrolizumab, and the effects will be observed to see how the cancer responds. The study will also include a comparison with a placebo to evaluate the effectiveness of the treatment. The trial aims to gather information on the response of the cancer to the treatment, as well as any side effects that may occur. This will help researchers understand the potential benefits and risks of using pembrolizumab in treating Stage IIb/c melanoma.

The study will monitor various outcomes, such as the rate at which the cancer responds to the treatment, the occurrence of any side effects, and the overall survival of the participants. By collecting this data, the trial seeks to provide valuable insights into the use of pembrolizumab as a treatment option for patients with this type of melanoma. The findings could contribute to improving treatment strategies and outcomes for individuals affected by this disease.

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 trial
Upon joining the trial, you will be required to provide a signed informed consent. This document confirms your understanding and agreement to participate in the study.
You must be at least 18 years old and have a confirmed diagnosis of stage IIb/c melanoma. This means the melanoma is either more than 2.0 mm thick with ulceration or more than 4.0 mm thick without ulceration.
A blood test will be conducted to ensure adequate organ function. Female participants of childbearing potential will need to take a pregnancy test within 72 hours before receiving the first treatment.
Step 2
Treatment preparation
Before starting the treatment, you will be scheduled for a wide local excision and sentinel lymph node biopsy. This is a surgical procedure to remove the melanoma and check if it has spread to nearby lymph nodes.
You will be required to use an adequate method of contraception during the study and for 150 days after the last dose of the study medication. Abstinence is acceptable if it is your usual lifestyle.
Step 3
Treatment administration
You will receive a single dose of the study medication, pembrolizumab, at a dosage of 400 mg. This medication is administered through an intravenous infusion, which means it is given directly into your vein.
The infusion will be prepared using a solution called sodium chloride, which is a common fluid used in medical treatments.
Step 4
Post-treatment monitoring
After receiving the treatment, you will be monitored for any side effects or adverse events. This includes regular check-ups to assess your health and the response of the melanoma to the treatment.
The primary goal is to measure the pathological response, which refers to how the melanoma cells react to the treatment before surgery.
Step 5
Surgery
Following the treatment and monitoring phase, you will undergo surgery to remove the melanoma. This is a planned part of the trial to evaluate the effectiveness of the treatment.
The surgery will also help in assessing the sentinel lymph node positivity rate, which indicates whether the cancer has spread to the lymph nodes.
Step 6
Follow-up
After surgery, you will continue to be monitored for any recurrence of melanoma and overall survival. This includes regular follow-up visits to track your health status.
The study aims to gather information on various outcomes, such as recurrence-free survival and melanoma-specific survival, to better understand the long-term effects of the treatment.

Who can join the trial?

9 criteria

Patient is 18 years or older.
Patient has signed informed consent, meaning they understand the study and agree to participate.
Patient has an ECOG performance status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Patient has a confirmed diagnosis of stage IIb/c melanoma, which is a type of skin cancer. The tumor must be larger than 2.0 mm with ulceration or larger than 4.0 mm without ulceration, and it should not be completely removed by the initial biopsy.
Patient is planned for wide local excision and sentinel lymph node biopsy, which are surgical procedures to remove the tumor and check if cancer has spread.
Patient has adequate organ function based on blood tests, meaning their organs are working well enough to participate in the study.
Female patients who can have children must have a negative pregnancy test within 72 hours before receiving the first treatment. If the urine test is positive or unclear, a blood test will be needed.
Female patients who can have children must be willing to use an adequate method of contraception during the study and for 150 days after the last dose of study medication. Abstinence is acceptable if it is their usual lifestyle and preferred method of contraception.
Male patients who can have children must agree to use an adequate method of contraception starting with the first dose of study therapy and for 150 days after the last dose. Abstinence is acceptable if it is their usual lifestyle and preferred method of contraception.

Who cannot join the trial?

7 criteria

Patients with any other type of cancer besides Stage IIb/c melanoma cannot participate.
Patients who have received any other treatment for melanoma before the study cannot participate.
Patients with a history of severe allergic reactions to medications cannot participate.
Patients with active infections that require treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with any other serious medical conditions that could interfere with the study cannot participate.
Patients who are unable to comply with the study procedures cannot participate.

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Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Gothenburg, Sweden

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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. In this trial, pembrolizumab is given to patients with a type of skin cancer called melanoma before they undergo surgery. The goal is to see how well the cancer responds to the treatment before it is removed surgically. Pembrolizumab is designed to block a specific protein on cancer cells, which can help your immune system recognize and attack these cells more effectively.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials for its effectiveness in treating stage IIb/c melanoma, a type of skin cancer. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps boost the body's natural defenses against cancer.

Investigated diseases

Stage IIb/c melanoma – Melanoma is a type of skin cancer that begins in the melanocytes, which are the cells responsible for producing the pigment melanin. Stage IIb/c melanoma indicates a more advanced form of the disease, where the tumor is thicker and may have ulceration, but it has not yet spread to the lymph nodes or distant sites. In this stage, the melanoma is typically more than 2 mm thick, and it may or may not have broken through the skin's surface. The progression of stage IIb/c melanoma involves the potential for local growth and the risk of spreading to nearby tissues. As the disease advances, there is an increased likelihood of recurrence and metastasis, which is the spread of cancer cells to other parts of the body. Monitoring and managing the disease at this stage is crucial to prevent further progression.