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Study Comparing MK-7684A (Vibostolimab and Pembrolizumab) with Pembrolizumab for Adults and Children with High-Risk Stage II-IV 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

This clinical trial is focused on studying a type of skin cancer known as melanoma. The study is comparing two treatments: one is a combination of two medications, MK-7684A (which includes pembrolizumab and vibostolimab), and the other is pembrolizumab alone. Both treatments are given as a solution through an intravenous infusion, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to see how well the combination treatment works compared to the single medication in preventing the return of melanoma after it has been surgically removed. Participants in the study will be randomly assigned to receive either the combination treatment or the single medication. Some participants may receive a placebo, which is a substance with no active medication. The study will last for up to 12 months, during which time participants will receive regular infusions and be monitored for any changes in their condition.

Throughout the study, researchers will keep track of how long participants remain free from melanoma returning, as well as other important health outcomes. These include how long participants live without the cancer spreading to other parts of the body, overall survival rates, and any side effects experienced. The study will also assess changes in participants' quality of life and physical functioning. This information will help determine the effectiveness and safety of the combination treatment compared to the single medication.

The research process

The trial runs in 4 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 randomly assigned to one of two groups. One group will receive the combination of MK-7684A (vibostolimab with pembrolizumab), and the other group will receive pembrolizumab alone.

    This assignment is done randomly, like flipping a coin, to ensure fairness and objectivity in the study.

  2. Step 2

    Treatment administration

    You will receive the assigned medication through an intravenous infusion. This means the medication will be given directly into your vein using a needle.

    The infusion will be administered at regular intervals as determined by the study protocol. The exact schedule and duration will be explained to you by the study team.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups and tests to assess your response to the treatment and to ensure your safety.

    You will be asked to report any side effects or changes in your health to the study team immediately.

  4. Step 4

    Completion of the study

    At the end of the study period, you will undergo a final evaluation to assess the outcomes of the treatment.

    The study team will discuss the results with you and provide guidance on any further steps or treatments that may be necessary.

Who can join the trial?

7 criteria

  • Must have a diagnosis of Stage IIB, IIC, III, or IV cutaneous melanoma that has been confirmed by examining tissue samples under a microscope.
  • Must have had surgery to remove the melanoma.
  • Must not have received any treatment for melanoma other than surgery.
  • Must have had no more than 12 weeks between the last surgery and the start of the study.
  • If the participant has HIV (Human Immunodeficiency Virus), it must be well controlled with medication.
  • Open to both male and female participants.
  • Participants of all age groups are eligible.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than melanoma.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to give informed consent or understand the study requirements.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a serious medical condition that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or major medical procedure.
  • Patients who have an allergy to the study medication or its ingredients.
  • Patients who have a history of substance abuse or addiction.
  • Patients who have an active infection that requires treatment.
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Investigated drugs

  • MK-7684A

    is a combination of two medications, Vibostolimab and Pembrolizumab, used together to help the body's immune system fight cancer. This combination is being tested to see if it can help prevent melanoma, a type of skin cancer, from coming back after surgery. Vibostolimab is a type of drug that helps activate the immune system to attack cancer cells, while Pembrolizumab is already used to treat various cancers by blocking a pathway that cancer cells use to hide from the immune system.

  • Pembrolizumab

    is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific pathway that cancer cells use to avoid being attacked by the immune system. This medication is already used in treating several types of cancer, including melanoma, and is being tested in this trial to see how well it works compared to the combination of Vibostolimab and Pembrolizumab.

What is already known about the treatment

MK-7684A (Vibostolimab with Pembrolizumab) – This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating high-risk stage II-IV melanoma, a type of skin cancer. It is in the experimental phase and is being compared to pembrolizumab, a well-known cancer treatment, to see which is more effective in preventing the return of cancer after initial treatment. MK-7684A works by helping the immune system recognize and attack cancer cells more effectively. It belongs to a class of drugs known as immune checkpoint inhibitors, which are designed to boost the body's natural defenses 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 grow deeper into the skin and spread to other parts of the body, including lymph nodes and internal organs. The disease is known for its ability to metastasize, or spread, rapidly if not detected early. Melanoma can occur on any skin surface, but it is more common in areas exposed to the sun, such as the back, legs, arms, and face. Early detection and monitoring of changes in the skin are crucial in managing the progression of melanoma.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501417-31-01Protocol codeMK-7684A-010Estimated enrolment1 595 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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