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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Jena KöR	Jena	Germany
Universitaet Leipzig	Leipzig	Germany

Other Sites

Site Name	City	Country
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Mannheim GmbH	Mannheim	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Universitaetsklinikum Ulm AöR	Ulm	Germany
Klinikum Kassel GmbH	Kassel	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Klinikum Ernst von Bergmann gGmbH	Potsdam	Germany
Ueivnxuaji Hdptgrvd Cxcsduz	Cologne	Germany
Uqcfdkuuphlfthryskcrw Wnvqvcslo Ajs	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2023

Trial locations

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.

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 ID:

2022-502751-61-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?