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Study of MK-7684A and Pembrolizumab for Patients with Advanced Solid Tumors

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 the effects of a new treatment called MK-7684A, which is a combination of two substances: pembrolizumab and vibostolimab. The study is being conducted on patients with various types of advanced solid tumors, which are cancers that have spread and are not easily removed by surgery. These include cancers such as cervical cancer, endometrial cancer, head and neck cancer, biliary cancer, esophageal cancer, triple-negative breast cancer, liver cancer, bladder cancer, ovarian cancer, and stomach cancer.

The purpose of the study is to compare the effectiveness of MK-7684A with another treatment, pembrolizumab alone, in patients with certain types of cancer. The study will also explore how well MK-7684A works when used with other cancer treatments. Some participants will receive a placebo, which is a substance with no active medication, to help researchers understand the true effects of the treatments being tested.

Participants in the study will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for several months, during which time participants will be monitored closely by healthcare professionals. The goal is to see how the treatments affect the cancer and to gather information on any side effects that may occur. This research is important for developing new and effective treatments for people with advanced cancers.

The research process

The trial runs in 6 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, the participant will be informed about the trial's objectives and procedures. Consent will be obtained to ensure understanding and agreement to participate.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to confirm eligibility. This includes verifying the presence of advanced solid tumors and ensuring adequate organ function.

    Blood pressure will be checked to ensure it is adequately controlled, and any necessary adjustments to medications will be made.

  3. Step 3

    Treatment phase

    Participants will receive the study medication, MK-7684A, which is a combination of vibostolimab and pembrolizumab. This will be administered through an intravenous infusion.

    The treatment may be given alone or in combination with other anticancer therapies, depending on the specific requirements of the study cohort.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring will occur to assess the response to treatment. This includes imaging studies to evaluate tumor size and progression.

    Participants will be monitored for any side effects or adverse events throughout the study duration.

  5. Step 5

    Evaluation of outcomes

    The primary outcomes being measured are the objective response rate and progression-free survival, as assessed by independent review.

    Secondary outcomes include overall survival and changes in quality of life scores.

  6. Step 6

    Completion of the study

    The study is estimated to conclude by February 2025. Participants will have a final assessment to determine the overall impact of the treatment.

Who can join the trial?

16 criteria

  • Have one of the following confirmed advanced solid tumors:
    • Squamous cell carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix
    • Endometrial cancer
    • Head and neck squamous cell carcinoma (HNSCC)
    • Unresectable biliary adenocarcinoma (cancer of the gallbladder or bile ducts)
    • Adenocarcinoma or squamous cell carcinoma of the esophagus or advanced/metastatic Siewert type 1 adenocarcinoma of the gastroesophageal junction (GEJ)
    • Triple-negative breast cancer (TNBC)
    • Hepatocellular carcinoma (HCC), a type of liver cancer
    • Urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra
    • Ovarian cancer
    • Gastric cancer, which is stomach cancer
    • Have a measurable disease according to specific medical guidelines
    • Have blood pressure that is well controlled, with or without medication
    • If infected with the human immunodeficiency virus (HIV), the infection must be well controlled with medication
    • Male participants must agree to use birth control methods
    • Female participants must not be pregnant or breastfeeding, and if they can have children, they must agree to use birth control methods
    • Have organs that are functioning well enough to participate

Who cannot join the trial?

3 criteria

  • Participants with **cervical cancer** whose tumors express **PD-L1** (a protein found on some cancer cells) are not eligible for certain parts of the study.
  • Participants with **BRCA1/2 nonmutated** and **HRD-negative** advanced epithelial ovarian cancer are not eligible for certain parts of the study. **BRCA1/2** are genes that, when mutated, can increase cancer risk. **HRD-negative** means the cancer does not have a specific type of genetic instability.
  • Participants who are part of a **vulnerable population** are not eligible. This means people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • MK-7684A

    is a combination of two medications, vibostolimab and pembrolizumab. It is being studied for its effectiveness in treating certain types of solid tumors, including cervical cancer. This combination aims to enhance the body's immune response against cancer cells by targeting specific proteins that help tumors evade the immune system.

  • Pembrolizumab (MK-3475)

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1, which can prevent the immune system from attacking cancer cells. This medication is being tested alone and in combination with other therapies to see how well it works in treating cervical cancer and other solid tumors.

What is already known about the treatment

Vibostolimab – Vibostolimab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced solid tumors. It is often combined with pembrolizumab, another cancer therapy, to enhance its effects. The main therapeutic indication for vibostolimab is in the treatment of various solid tumors, including cervical cancer and ovarian cancer. At the molecular level, vibostolimab works by targeting and inhibiting specific proteins that help cancer cells evade the immune system, thereby enhancing the body's ability to fight cancer. It is classified as an immune checkpoint inhibitor, a type of drug that helps to activate the immune system against cancer cells.

Investigated diseases

  • Advanced Solid Tumors

    Advanced solid tumors refer to a group of cancers that have formed solid masses and have progressed beyond their initial site. These tumors can occur in various organs and tissues, such as the lungs, liver, or pancreas. As they advance, they may invade nearby tissues and spread to other parts of the body. The progression of these tumors can lead to increased size and number of cancerous masses. Symptoms often depend on the location and size of the tumor, potentially causing pain, swelling, or organ dysfunction. The growth and spread of these tumors can significantly impact the body's normal functions.

  • Cervical Cancer

    Cervical cancer originates in the cells of the cervix, the lower part of the uterus that connects to the vagina. It typically develops slowly over time, beginning with precancerous changes in the cervical cells. As the disease progresses, it can invade deeper tissues of the cervix and spread to nearby areas, such as the vagina or lymph nodes. In advanced stages, cervical cancer may metastasize to distant organs, including the lungs or liver. Symptoms can include abnormal vaginal bleeding, pelvic pain, or pain during intercourse. The progression of cervical cancer is often linked to persistent infection with certain types of human papillomavirus (HPV).

  • Advanced Epithelial Ovarian Cancer

    Advanced epithelial ovarian cancer is a type of cancer that begins in the layer of cells covering the ovaries. It is often diagnosed at a late stage due to subtle symptoms, such as bloating, abdominal pain, or changes in bowel habits. As the cancer progresses, it can spread to the lining of the abdomen, lymph nodes, or distant organs. The disease may cause fluid buildup in the abdomen, known as ascites, leading to discomfort and swelling. The progression of this cancer can interfere with normal ovarian and abdominal functions. It is more common in women who have gone through menopause.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505284-36-00Protocol codeMK-7684A-005Estimated enrolment638 patientsSponsorMerck Sharp & Dohme LLC

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