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Study of Pembrolizumab for Patients with High-Risk Stage IIB/IIC Melanoma

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

The clinical trial focuses on studying a type of skin cancer known as cutaneous melanoma, specifically in its high-risk stages IIB and IIC. The treatment being tested is called pembrolizumab, which is also known by its brand name, KEYTRUDA. Pembrolizumab is a medication given through an infusion, which means it is delivered directly into the bloodstream. This study aims to understand how effective pembrolizumab is when given before surgery to remove the melanoma.

The purpose of the study is to see how well pembrolizumab works in shrinking the melanoma before surgery. Participants in the study will receive pembrolizumab as a neoadjuvant treatment, which means it is given before the main treatment, in this case, surgery. The study will monitor the response of the melanoma to the treatment, looking for a major pathological response, which means a significant reduction in cancer cells in the tumor. The study will also track any side effects or adverse events that participants may experience during the treatment.

Throughout the study, participants will undergo regular check-ups and assessments to monitor their health and the progress of the treatment. The study will also evaluate the long-term outcomes for participants, such as event-free survival, which is the time from the start of treatment until the cancer progresses or other significant events occur. The study is expected to continue until 2029, providing valuable information on the effectiveness and safety of pembrolizumab as a treatment for high-risk cutaneous melanoma.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide a signed and dated informed consent form. This confirms your understanding and agreement to participate in the study.

    You must meet specific criteria, such as being 18 years or older, having a confirmed diagnosis of stage IIB or IIC melanoma, and being able to comply with the study protocol.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to evaluate your health status and confirm eligibility. This includes a review of your medical history and a physical examination.

    A biopsy of the melanoma lesion will be performed to confirm the diagnosis and assess the tumor's characteristics.

  3. Step 3

    Neoadjuvant treatment

    You will receive the medication pembrolizumab, which is administered as an infusion. This involves receiving the medication through a vein over a period of time.

    The dosage and frequency of the infusion will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment, regular monitoring will be conducted to assess your response to the medication and any side effects.

    This includes clinical examinations and standardized photographs of the primary tumor to evaluate changes in size or appearance.

  5. Step 5

    Surgery

    Following the neoadjuvant treatment, surgery will be performed to remove the primary tumor.

    The surgical specimen will be evaluated to determine the response to the treatment, focusing on the presence of viable tumor cells.

  6. Step 6

    Post-surgery follow-up

    After surgery, follow-up visits will be scheduled to monitor your recovery and check for any signs of melanoma recurrence.

    Additional treatments may be recommended based on the surgical findings and your overall health status.

  7. Step 7

    Completion of study

    The study will conclude after the final follow-up visit, which will assess your long-term health outcomes and any lasting effects of the treatment.

    Your participation in the study will contribute to understanding the effectiveness of pembrolizumab in treating high-risk melanoma.

Who can join the trial?

16 criteria

  • Must be at least 18 years old.
  • Must be able to follow the study instructions, as judged by the study doctor.
  • Must sign and date a form agreeing to participate in the study.
  • Must have a type of skin cancer called primary cutaneous melanoma. A small number of patients with a specific type called acral melanoma can also join.
  • Must have a specific stage of melanoma, known as AJCC 8 stage IIB or IIC. This includes:
    • T3b: Tumor is more than 2mm thick and has an open sore (ulcerated).
    • T4a: Tumor is more than 4mm thick and does not have an open sore (non-ulcerated).
    • T4b: Tumor is more than 4mm thick and has an open sore (ulcerated).
    • Must have a confirmed diagnosis through a small tissue sample (biopsy) of the lesion.
    • The primary tumor must be able to be surgically removed (operable).
    • Must have a visible tumor larger than 2mm, which can be seen in photos or scans.
    • Must have a performance status of less than 2 on the ECOG scale, which measures daily living abilities.
    • Women who can have children must use highly effective birth control and have a negative pregnancy test before starting the study. Women who cannot have children must meet certain criteria, such as:
      • Being post-menopausal, which means over 50 years old and not having a period for at least 12 months after stopping hormone treatments.
      • Women under 50 can be considered post-menopausal if they haven't had a period for 12 months after stopping hormone treatments and have certain hormone levels.
      • Having had surgery that permanently prevents pregnancy, like removal of the uterus or ovaries.
      • Men with partners who can have children must use barrier contraception during the study and for 6 months after stopping the study drug. They should also not donate sperm during this time.
      • Must be part of or have benefits from the French social security system.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides melanoma cannot participate.
  • Patients who have received any other treatment for melanoma before the study cannot participate.
  • Patients with serious heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions to similar drugs cannot participate.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
  • Patients who have received a live vaccine within 30 days before the study cannot participate.
  • Patients with a history of drug or alcohol abuse that could interfere with the study cannot participate.
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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 used before surgery to treat patients with a specific type of skin cancer called melanoma. The goal is to see if the medication can shrink the tumor and make it easier to remove during surgery. By boosting the body's natural defenses, pembrolizumab aims to improve the chances of a successful treatment outcome.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an injection into a vein, typically given in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating high-risk, stage IIB/IIC 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 specific 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 enhances the body's immune response against cancer.

Investigated diseases

Melanoma – Melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It often begins as a mole that changes in size, shape, or color, but it can also appear on skin that looks normal. As melanoma progresses, it can invade deeper layers of the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is characterized by its ability to grow quickly and metastasize, making early detection crucial. Melanoma can vary in appearance, sometimes presenting as a flat or slightly raised lesion with irregular edges and multiple colors. It is more common in individuals with fair skin, but it can affect anyone, regardless of skin type.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-519573-19-00Protocol code2024/880Estimated enrolment19 patientsSponsorCentre Hospitalier Regional Universitaire

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