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Study of Pembrolizumab and Cisplatin for Patients with Stage III-IVA Resectable Head and Neck Cancer

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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 cancer called Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). The study is investigating the use of a treatment called pembrolizumab, which is also known by its code name MK-3475. Pembrolizumab is being tested as a therapy given before surgery (neoadjuvant therapy) and in combination with standard treatments after surgery (adjuvant therapy). The standard treatments include radiotherapy, which uses high-energy rays to kill cancer cells, and may also include a drug called cisplatin, which is a type of chemotherapy that helps stop the growth of cancer cells.

The purpose of the study is to compare the effectiveness of pembrolizumab combined with radiotherapy and possibly cisplatin, against the standard treatment of radiotherapy with or without cisplatin. The study will look at how long participants remain free from cancer events, which means the cancer does not return or worsen. Participants in the study will receive their treatments through an intravenous infusion, which means the medication is given directly into a vein.

Throughout the study, participants will be monitored to see how their cancer responds to the treatment and to check for any side effects. The study aims to understand if adding pembrolizumab to the standard treatment can improve outcomes for patients with this type of head and neck cancer. The trial will also assess other factors such as overall survival, which is the length of time participants live after starting the study, and changes in quality of life, which refers to the overall well-being of participants during and after treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A biopsy of the tumor is performed if not previously done, and imaging tests such as a CT scan or MRI are conducted to evaluate the tumor size and spread.

  2. Step 2

    Neoadjuvant therapy

    The first phase of treatment involves receiving **pembrolizumab** as neoadjuvant therapy. This medication is administered through an intravenous infusion.

    The infusion is given at a healthcare facility, and the schedule and duration are determined by the study protocol.

  3. Step 3

    Surgery

    After completing the neoadjuvant therapy, surgery is performed to remove the tumor. The timing of the surgery is based on the response to the initial treatment.

  4. Step 4

    Adjuvant therapy

    Following surgery, adjuvant therapy is administered. This may include **pembrolizumab** in combination with radiotherapy, with or without **cisplatin**.

    Both **pembrolizumab** and **cisplatin** are given through intravenous infusion. The frequency and duration of these treatments are specified in the study protocol.

  5. Step 5

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor health status and response to treatment. These assessments may include physical exams, imaging tests, and laboratory tests.

    The follow-up period continues for the duration of the study, which is estimated to end in July 2026.

Who can join the trial?

9 criteria

  • Has a new diagnosis of a type of cancer called squamous cell carcinoma in the head and neck area that can be surgically removed and has not spread to other parts of the body.
  • Is eligible for primary surgery based on the decision of the study doctor and local medical practices.
  • If female or male and able to have children, must agree to use effective birth control during the study and for 180 days after the last dose of study treatment.
  • If male, must agree not to donate sperm during the study and for 180 days after the last dose of study treatment.
  • If female, must not be pregnant or breastfeeding.
  • Has a tumor that can be measured or evaluated using a CT scan or MRI scan.
  • Has provided a new sample of the tumor tissue that has not been treated with radiation before.
  • Has results from a local test to check for HPV status in oropharyngeal cancer using a specific test called p16 IHC.
  • Has a performance status score of 0 or 1, which means the person is fully active or has some symptoms but can carry out light work, assessed within 10 days before starting the study.

Who cannot join the trial?

15 criteria

  • Patients with any other type of cancer that is not the specific type being studied.
  • Patients who have had a different cancer in the past, unless it was a type that is not likely to come back.
  • Patients who have had a severe allergic reaction to any of the drugs being used in the study.
  • Patients with an active infection that requires treatment with antibiotics.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of heart problems, such as a heart attack or heart failure.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of lung disease that makes it hard to breathe.
  • Patients with a history of liver disease.
  • Patients with a history of kidney disease.
  • Patients who are currently participating in another clinical trial.
  • Patients who have received an organ transplant.
  • Patients with a history of autoimmune disease, which is when the body's immune system attacks its own cells.
  • Patients with a history of drug or alcohol abuse.
  • Patients who are unable to follow the study procedures or attend the required visits.
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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 shrink the tumor and after surgery to help prevent the cancer from coming back. It is given to patients with a specific type of head and neck cancer.

  • Cisplatin

    is a chemotherapy drug that helps kill cancer cells. It is often used in combination with other treatments to increase its effectiveness. In this trial, cisplatin is used after surgery along with radiation therapy to help destroy any remaining cancer cells and reduce the risk of the cancer returning.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials as a treatment for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). 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 can help the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of drug that helps to boost the body's natural defenses against cancer.

Investigated diseases

Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC) – This disease is a type of cancer that occurs in the squamous cells lining the moist surfaces inside the head and neck. It is considered locoregionally advanced, meaning it has spread from its original site to nearby tissues or lymph nodes but is still potentially resectable, or removable, through surgery. The progression of this carcinoma involves the growth and spread of malignant cells, which can invade surrounding structures and potentially affect functions such as swallowing and speaking. As the disease advances, it may cause symptoms like persistent sore throat, difficulty swallowing, and changes in voice. The cancer can also lead to the formation of lumps or sores that do not heal. The progression is influenced by factors such as the size and location of the tumor and the involvement of lymph nodes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500254-41-00Protocol codeMK-3475-689Estimated enrolment680 patientsSponsorMerck Sharp & Dohme LLC

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