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Study Comparing MK-7684A (Vibostolimab and Pembrolizumab) with Pembrolizumab for Adults and Children with High-Risk 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 treatments for high-risk melanoma, a type of skin cancer that has been surgically removed but still poses a risk of returning. The study is comparing two treatments: one is a combination of two medications, pembrolizumab and vibostolimab, known together as MK-7684A, and the other is pembrolizumab alone. Pembrolizumab is a medication that helps the immune system fight cancer cells, while vibostolimab is another drug that works with pembrolizumab to enhance this effect.

The purpose of the study is to see which treatment is more effective in preventing the cancer from coming back. Participants in the study will receive one of these treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for up to 12 months, during which time participants will be monitored regularly to check for any signs of the cancer returning and to assess their overall health and well-being.

Throughout the study, researchers will also keep track of any side effects experienced by participants and how these might affect their quality of life. The goal is to gather information that will help determine the best treatment option for people with high-risk melanoma, aiming to improve their chances of staying cancer-free for as long as possible.

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 pembrolizumab and vibostolimab, while the other group will receive only pembrolizumab.

    This process is double-blind, meaning neither you nor the study team will know which group you are in to ensure unbiased results.

  2. Step 2

    Treatment administration

    You will receive the treatment through an intravenous infusion, which means the medication will be given directly into your vein.

    The dosage and frequency of the medication will be determined by the study protocol, and you will be informed about the schedule and duration of your treatment.

  3. Step 3

    Monitoring and follow-up

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment.

    These check-ups will include physical examinations, blood tests, and possibly other assessments to ensure your safety and to gather data for the study.

  4. Step 4

    Completion of treatment

    Once the treatment period is over, you will have a final evaluation to assess your response to the treatment.

    You may be asked to continue with follow-up visits to monitor your long-term health and any potential late effects of the treatment.

Who can join the trial?

6 criteria

  • Must have had surgery to remove melanoma and have a confirmed diagnosis of Stage IIB, IIC, III, or IV cutaneous melanoma according to the American Joint Committee on Cancer (AJCC) guidelines.
  • Must not have received any prior treatment for melanoma other than surgery.
  • Must have had no more than 12 weeks between the final surgery and the start of the study.
  • If the participant is infected with HIV (Human Immunodeficiency Virus), their condition must be well controlled with anti-retroviral therapy (ART).
  • Open to both male and female participants.
  • Includes participants from vulnerable populations.

Who cannot join the trial?

7 criteria

  • Patients with any other type of cancer that is not high-risk resected melanoma cannot participate.
  • Patients who have had a different cancer treatment in the past that might interfere with the study cannot participate.
  • Patients with a serious infection or illness that could affect their ability to participate safely cannot join the study.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a known allergy to any of the study medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
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Investigated drugs

  • MK-7684A

    is a combination of two medications, Vibostolimab and Pembrolizumab. This combination is being tested to see if it can help people with high-risk melanoma, a type of skin cancer, by preventing the cancer from coming back after surgery. Vibostolimab is a type of medication that helps the immune system recognize and attack cancer cells. Pembrolizumab, which is already used to treat melanoma, works in a similar way by boosting the immune system's ability to fight cancer.

  • Pembrolizumab

    is a medication that helps the body's immune system fight cancer. It is already used to treat melanoma and works by blocking a specific protein that prevents the immune system from attacking cancer cells. In this study, Pembrolizumab is being used as a comparison to see if the combination of Vibostolimab and Pembrolizumab (MK-7684A) is more effective in preventing the return of melanoma after surgery.

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 resected 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. The main therapeutic use of MK-7684A is to help the immune system recognize and attack cancer cells. It works by blocking certain proteins that cancer cells use to hide from the immune system, allowing the body to better fight the cancer. This medication falls under the category of immunotherapy, which uses the body's own immune system to combat diseases.

Investigated diseases

High-risk Resected Melanoma – High-risk resected melanoma is a type of skin cancer that has been surgically removed but has a high chance of returning. It originates in the melanocytes, which are the cells responsible for producing pigment in the skin. After surgical removal, the disease may progress by spreading to nearby lymph nodes or distant organs if not completely eradicated. The risk of recurrence is higher in cases where the melanoma was thick, ulcerated, or had spread to the lymph nodes at the time of initial diagnosis. Monitoring for recurrence is crucial, as the disease can reappear in the same area or metastasize to other parts of the body. The progression of the disease is influenced by various factors, including the original tumor's characteristics and the patient's immune response.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501417-31-00Protocol codeMK-7684A-010Estimated enrolment1 806 patientsSponsorMerck Sharp & Dohme LLC

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