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Study on Advanced Laryngeal and Hypopharyngeal Cancer: Comparing Docetaxel, Cisplatin, and Pembrolizumab for Patients Eligible for Laryngectomy

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 advanced forms of head and neck cancer, specifically those affecting the larynx and hypopharynx, which are parts of the throat. The study aims to explore the effectiveness of adding a medication called pembrolizumab to the standard treatment. Pembrolizumab is also known by its code name MK-3475 and is used to help the immune system fight cancer. The standard treatment involves chemotherapy with drugs like docetaxel and cisplatin, followed by radiation therapy. The goal is to see if adding pembrolizumab can help patients avoid a surgery called a laryngectomy, which involves removing the voice box.

Participants in the study will receive either the standard treatment or the standard treatment plus pembrolizumab. The study will monitor patients over a period of 24 to 48 months to see how many can avoid laryngectomy and how long they live without the cancer returning. The study will also look at the quality of swallowing, which is an important aspect of life for patients with throat cancer. Other medications that may be used in the study include clindamycin, an antibiotic, and dexamethasone, an anti-inflammatory drug, to manage side effects or other conditions.

The purpose of this study is to improve the treatment outcomes for patients with advanced head and neck cancer by potentially offering a treatment option that preserves the larynx and improves survival rates. The study will help determine if pembrolizumab can be a beneficial addition to the current treatment protocol for these types of cancer.

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 treatment phase

    The initial phase involves the administration of docetaxel and cisplatin through infusion. This is known as induction chemotherapy. The purpose is to evaluate the early response of the cancer to the treatment.

    The specific dosage and frequency of these medications will be determined by the healthcare provider based on individual patient needs and response.

  2. Step 2

    Evaluation of response

    After the initial treatment phase, an evaluation is conducted to assess the response of the cancer to the chemotherapy. This helps in determining the next steps in the treatment plan.

  3. Step 3

    Additional treatment phase

    If the cancer shows a suitable response, the treatment may include the addition of pembrolizumab, which is administered as an infusion. This medication is intended to enhance the effectiveness of the treatment by inhibiting certain proteins that help cancer cells evade the immune system.

    The frequency and duration of pembrolizumab administration will be specified by the healthcare provider.

  4. Step 4

    Radiation therapy

    Following the chemotherapy and potential addition of pembrolizumab, radiation therapy is administered. This phase aims to further target and destroy cancer cells in the larynx or hypopharynx.

  5. Step 5

    Follow-up and monitoring

    Regular follow-up appointments are scheduled to monitor the patient's health and the effectiveness of the treatment. This includes assessing the quality of swallowing and overall survival.

    The follow-up period extends from 24 to 48 months, during which the patient's condition is closely observed to ensure the larynx is preserved and to monitor for any signs of cancer recurrence.

Who can join the trial?

8 criteria

  • Participants must be at least 18 years old and have a confirmed diagnosis of a specific type of cancer in the throat area, known as squamous cell carcinoma of the larynx or hypopharynx, which can be treated with a surgery called total laryngectomy.
  • The cancer must be at stage II, III, or IVA-IVB, and it should be possible to remove it completely with clear margins, meaning no cancer cells are left at the edges of the removed tissue. There should be no signs of cancer spreading beyond the neck nodes on imaging tests.
  • Participants must provide a new sample of the tumor tissue that has not been treated with radiation before. This sample should ideally be in the form of a tissue block preserved in a specific way.
  • The tumor sample must show a certain level of a protein called PD-L1, which is measured using a specific test. This is important for the treatment being studied.
  • Male participants must agree to use birth control during the study and for at least 120 days after the last treatment dose, and they should not donate sperm during this time.
  • Female participants must not be pregnant or breastfeeding. They must either be unable to have children or agree to use birth control during the study and for at least 120 days after the last treatment dose.
  • Participants must have a good general health status, as measured by a scale called the Eastern Cooperative Oncology Group (ECOG) performance status, with a score of 0 or 1. This assessment should be done within 7 days before starting the study.
  • Participants must have normal functioning of their organs, as defined in the study protocol, with tests done within 10 days before starting the study treatment.

Who cannot join the trial?

2 criteria

  • Patients who do not have advanced stage II, III, IVA/B head and neck squamous cell carcinoma of the larynx or hypopharynx that can be treated by removing the larynx completely.
  • Patients whose tumor tissue biopsy does not show PD-L1-expression with a CPS (Combined Positive Score) of 1 or more. This means the tumor must have a certain level of a specific protein to qualify.
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Investigated drugs

  • Docetaxel

    is a medication used in this trial as part of the induction chemotherapy. It works by interfering with the growth of cancer cells, slowing down or stopping their spread. In this study, it is used to treat advanced laryngeal and hypopharyngeal cancer.

  • Cisplatin

    is another chemotherapy drug used in combination with Docetaxel. It helps to kill cancer cells by damaging their DNA, which prevents them from dividing and growing. This medication is part of the initial treatment phase in the trial.

  • Pembrolizumab

    is an immunotherapy drug that is being tested in this trial for its potential to improve outcomes in patients with advanced laryngeal and hypopharyngeal cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. The trial aims to see if adding Pembrolizumab to the standard treatment can improve survival without the need for laryngectomy.

What is already known about the treatment

  • Docetaxel

    Docetaxel is administered intravenously and is used in combination with other medications for treating certain types of cancer, including advanced head and neck cancer. It is currently well-established in medical literature as a chemotherapy agent. The main therapeutic indication for Docetaxel in this trial is to treat advanced laryngeal and hypopharyngeal cancer. It works by disrupting the microtubule network in cells, which is essential for cell division, thereby inhibiting cancer cell growth. Docetaxel is classified as a taxane chemotherapy drug.

  • Cisplatin

    Cisplatin is given through an intravenous infusion and is used in combination with other drugs to treat various cancers, including advanced head and neck cancer. It is a well-known and widely used chemotherapy agent in medical practice. In this trial, its main therapeutic use is for treating advanced laryngeal and hypopharyngeal cancer. Cisplatin works by forming cross-links in DNA, which prevents cancer cells from dividing and leads to cell death. It is classified as a platinum-based chemotherapy drug.

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion and is used to enhance the immune system's ability to fight cancer. It is currently approved and recognized in medical literature as an immunotherapy agent. In this trial, it is used to treat advanced laryngeal and hypopharyngeal cancer by inhibiting the PD-1 pathway, which helps the immune system recognize and attack cancer cells. Pembrolizumab is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that occurs in the squamous cells lining the head and neck region, specifically affecting areas such as the larynx and hypopharynx. It is characterized by the abnormal growth of cells in these regions, which can lead to tumors. As the disease progresses, it may cause symptoms like difficulty swallowing, changes in voice, and persistent sore throat. The cancer can spread to nearby tissues and lymph nodes, potentially affecting breathing and speech. Advanced stages may require surgical interventions such as laryngectomy to remove the affected areas. The progression and impact of the disease can vary based on the location and size of the tumor.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-502751-61-00Estimated enrolment140 patientsSponsorUniversitaet Leipzig

sourced from the EU Clinical Trials Register and site verification

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