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Study on Pembrolizumab and Radiotherapy for Patients with Limited Spread of 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 treating a type of cancer known as squamous cell carcinoma of the head and neck. The study is investigating the use of a medication called pembrolizumab, which is a type of immunotherapy. Immunotherapy is a treatment that helps the body's immune system fight cancer. In this study, pembrolizumab is being used in combination with a type of radiation therapy called stereotactic ablative body radiotherapy (SABR). SABR is a precise form of radiation therapy that targets cancer cells while minimizing damage to surrounding healthy tissue.

The purpose of the study is to determine if adding SABR to pembrolizumab can improve the time patients live without their cancer getting worse, compared to using pembrolizumab alone. The study involves patients who have a limited number of cancer spread sites, known as oligometastatic disease. Participants will receive treatment over a period of time and will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, participants will be assessed for various outcomes, including how long they live without the cancer progressing, overall survival, and any side effects they may encounter. The study will also gather information on how the treatment affects patients' quality of life, including symptoms like pain, fatigue, and appetite loss. This information will help researchers understand the benefits and challenges of using pembrolizumab and SABR together for treating head and neck 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

    Enrollment

    Upon joining the study, the patient will be required to provide written informed consent. This is a formal agreement to participate in the trial, acknowledging understanding of the study's purpose and procedures.

    Eligibility will be confirmed based on specific criteria, including age, health status, and previous treatments. The patient must have a confirmed diagnosis of squamous cell carcinoma of the head and neck with limited metastatic spread.

  2. Step 2

    Initial assessment

    The patient will undergo a series of assessments to establish baseline health status. This includes imaging tests to measure the extent of the disease and laboratory tests to ensure adequate organ function.

    The patient's performance status will be evaluated to ensure they are fit for treatment. This involves assessing the ability to perform daily activities.

  3. Step 3

    Treatment initiation

    The patient will begin treatment with pembrolizumab, administered intravenously. The specific dosage and frequency will be determined by the study protocol and the patient's health status.

    In addition to pembrolizumab, some patients may receive stereotactic ablative body radiotherapy (SABR) to target specific metastatic lesions.

  4. Step 4

    Treatment monitoring

    Throughout the treatment period, the patient will be closely monitored for any side effects or adverse reactions. Regular follow-up visits will be scheduled to assess the patient's response to treatment.

    The patient's disease progression will be evaluated using imaging tests and clinical assessments. Adjustments to the treatment plan may be made based on these evaluations.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment regimen, the patient will undergo a final assessment to determine the overall response to the therapy.

    The patient will be advised on follow-up care and any necessary ongoing monitoring to manage their health post-treatment.

Who can join the trial?

16 criteria

  • Participants must be male or female and at least 18 years old on the day they sign the consent form.
  • The disease must be measurable based on a specific guideline called RECIST 1.1, which helps doctors assess the size of tumors.
  • Participants should have a performance status of 0 to 1 according to the Eastern Cooperative Oncology Group (ECOG), which means they are fully active or have some symptoms but can still do light work.
  • Participants must have recovered from any side effects of previous treatments like radiotherapy, systemic treatment, or surgery, and should not need corticosteroids to manage side effects like swelling, lung inflammation, or pain.
  • Participants must have adequate organ function based on laboratory tests.
  • Women who can have children must have a negative pregnancy test within 72 hours before joining the study and again within 72 hours before the first dose of the study treatment.
  • Participants who can have children should use highly effective birth control methods during the study and for at least 4 months after the last dose. Men should not donate sperm during this time. Effective birth control methods include hormonal contraception, intrauterine devices, surgical procedures, or abstinence.
  • Women who are breastfeeding should stop nursing before the first dose of the study treatment and continue to avoid breastfeeding for 6 months after the last treatment.
  • Participants must provide written informed consent according to international and local regulations before joining the study.
  • Participants must have a confirmed diagnosis of squamous cell carcinoma of the head and neck, which is a type of cancer, in specific areas like the mouth, throat, or voice box, and have a limited number of metastatic lesions (1-5), which are cancer spots that have spread to other parts of the body.
  • Participants must be suitable for first-line systemic treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).
  • For participants with oropharyngeal cancer, their HPV status must be evaluated using a test called p16 IHC.
  • Participants must have a PD-L1 CPS of at least 1, which is a measure used to evaluate certain proteins in cancer cells.
  • The staging of the cancer must not be older than 12 weeks before joining the study.
  • All 1-5 metastases must be suitable for a treatment called SABR, which is a type of precise radiation therapy.
  • Participants must be eligible for treatment with a medication called pembrolizumab.

Who cannot join the trial?

5 criteria

  • Patients who have a different type of cancer than squamous cell carcinoma of the head and neck cannot participate.
  • Patients who do not have a PD-L1 CPS score of 1 or higher are excluded. PD-L1 CPS is a test that measures a protein on cancer cells.
  • Patients with more than 1-5 metastatic lesions are not eligible. Metastatic lesions are cancer spots that have spread to other parts of the body.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to give informed consent or are part of a vulnerable population may be excluded.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to treat squamous cell carcinoma of the head and neck. It works by helping the immune system recognize and attack cancer cells. Pembrolizumab is often used when the cancer has spread to other parts of the body, known as metastatic cancer.

  • Stereotactic Ablative Body Radiotherapy (SABR)

    is a type of radiation therapy used in this trial. It delivers high doses of radiation to specific areas of the body where cancer has spread. The goal of SABR is to target and destroy cancer cells while minimizing damage to surrounding healthy tissue. In this study, SABR is combined with pembrolizumab to see if it improves the outcomes for patients with oligometastatic disease, which means having a limited number of metastatic lesions.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently a well-established medication in the field of oncology, with extensive documentation in medical literature. The primary use of pembrolizumab is for treating various types of cancer, including squamous cell carcinoma of the head and neck. It works by blocking a specific protein on immune cells, known as PD-1, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth that can gradually expand and invade nearby tissues. As the disease progresses, it may spread to lymph nodes in the neck and potentially to other parts of the body. Symptoms often include a persistent sore throat, difficulty swallowing, and changes in voice. The disease can also cause visible lumps or sores that do not heal. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504478-39-00Protocol code2014-HNCGEstimated enrolment215 patientsSponsorEuropean Organisation For Research And Treatment Of Cancer

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