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Study on Pembrolizumab and Drug Combination for Patients with Recurrent 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 locoregionally recurrent head and neck squamous cell carcinoma (HNSCC). This is a condition where cancer returns in the head and neck area after initial treatment. The study will explore the effectiveness of a treatment plan that includes a combination of therapies. The main treatment being tested is pembrolizumab, which is a type of immunotherapy that helps the immune system fight cancer. The study will compare this treatment to the standard therapy, which may include pembrolizumab with or without chemotherapy.

The trial will involve several medications, including fluorouracil, carboplatin, and cisplatin, which are types of chemotherapy drugs. These medications are given to help stop the growth of cancer cells. The purpose of the study is to see if the new treatment plan can improve the overall survival of patients with this type of cancer. Participants in the study will receive these treatments over a period of time, and their health will be monitored to see how well the treatment works.

The study will follow a specific course where participants will receive the treatments through intravenous infusion, which means the medication is given directly into a vein. The trial aims to find out if the new treatment plan can help patients live longer and control the cancer better than the current standard treatments. The study will also look at other factors, such as how the treatment affects the quality of life and any side effects that may occur. The ultimate goal is to find a more effective way to treat this type of cancer and improve the lives of those affected by it.

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.

    Blood tests are performed to ensure normal organ and marrow function. This includes checking levels of hemoglobin, white blood cells, and platelets.

    A pregnancy test is conducted for females of childbearing potential within 72 hours before starting treatment.

  2. Step 2

    Treatment group assignment

    Participants are randomly assigned to one of two treatment groups. One group receives sequential re-radiochemotherapy followed by pembrolizumab, while the other group receives pembrolizumab with or without chemotherapy.

  3. Step 3

    Treatment phase

    For those in the sequential re-radiochemotherapy group, treatment begins with re-radiochemotherapy. This involves receiving radiation therapy along with chemotherapy drugs such as fluorouracil, carboplatin, or cisplatin through an intravenous infusion.

    After completing re-radiochemotherapy, participants receive pembrolizumab through an intravenous infusion. The frequency and duration of administration are determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor health and response to treatment. This includes physical examinations, blood tests, and imaging studies.

    Participants are asked to complete questionnaires to assess tumor symptoms, swallowing function, and quality of life.

  5. Step 5

    End of study participation

    The study concludes with a final assessment to evaluate overall health and treatment outcomes.

    Participants are monitored for any long-term effects of the treatment and are provided with appropriate care and guidance.

Who can join the trial?

18 criteria

  • Provide written informed consent before any study-related procedures. This means you agree to participate after being informed about the study.
  • Have normal organ and bone marrow function, which includes:
    • Hemoglobin (a protein in red blood cells) level of at least 9.0 g/dL.
    • White blood cells (WBC) count of at least 3,000 per mm3 or neutrophils (a type of white blood cell) count of at least 1,500 per mm3.
    • Platelet count (cells that help with blood clotting) greater than 100,000 per mm3.
    • Serum bilirubin (a substance made by the liver) level should be 1.5 times or less than the normal upper limit, unless you have Gilbert’s syndrome.
    • AST (SGOT) and ALT (SGPT) (liver enzymes) levels should be 2.5 times or less than the normal upper limit.
    • Creatinine clearance (a measure of kidney function) should be at least 40 ml/min.
    • If you are a female of childbearing potential, you must have a negative pregnancy test within 72 hours before starting treatment and use highly effective birth control during the study and for 120 days after the last dose.
    • If you are a male, you must agree to use highly effective birth control starting with the first dose and for 120 days after the last dose.
    • Be willing and able to follow the study protocol, including attending treatment sessions and scheduled visits.
    • Be at least 18 years old at the time of joining the study.
    • Have an ECOG performance status of 0, 1, or 2, which measures your ability to perform daily activities.
    • Have locoregionally recurrent or a second primary head and neck squamous cell carcinoma (HNSCC).
    • Have a confirmed diagnosis of HNSCC through a tissue sample.
    • The tumor cannot be surgically removed, or surgery would cause significant functional issues, or you refuse surgery.
    • No distant metastases, meaning the cancer has not spread to distant parts of the body.
    • Have a PD-L1 combined positive score (CPS) of 1 or more, determined by a validated test in an accredited lab. This score helps assess the likelihood of response to certain therapies.
    • Have had prior radio(chemo)therapy of the neck, with at least a 6-month interval since the last treatment.

Who cannot join the trial?

7 criteria

  • Patients with other types of cancer besides locoregionally recurrent head and neck squamous cell carcinoma (HNSCC) cannot participate.
  • Patients who have had a different type of cancer treatment recently may not be eligible.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study may be excluded.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients with known allergies to the study medications cannot participate.
  • Patients who are unable to follow the study procedures or attend the required visits may be excluded.
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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 to treat a type of cancer called HNSCC, which stands for head and neck squamous cell carcinoma. The goal is to see if pembrolizumab can help improve survival in patients whose cancer has come back in the same area after previous treatment.

  • Re-Radiochemotherapy

    is a combination of radiation therapy and chemotherapy. Radiation therapy uses high-energy rays to target and kill cancer cells, while chemotherapy uses drugs to stop the growth of cancer cells. In this trial, re-radiochemotherapy is given first, followed by pembrolizumab, to see if this sequence of treatments can be more effective in treating recurrent HNSCC compared to other standard treatments.

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 a well-established medication in the field of oncology, with numerous studies and medical literature supporting its use. The main therapeutic indication for pembrolizumab in this trial is for treating locoregionally recurrent head and neck squamous cell carcinoma (HNSCC) that is positive for PD-L1, a specific protein. At the molecular level, pembrolizumab works by blocking a pathway that cancer cells use to hide from the immune system, thereby allowing the immune system to recognize and attack the cancer cells. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the body's immune system fight cancer.

Investigated diseases

Locoregionally recurrent head and neck squamous cell carcinoma – This disease is a type of cancer that occurs in the squamous cells lining the head and neck region. It is characterized by the return of cancer in the same area after initial treatment. The progression involves the growth of cancerous cells in the local region, which can affect nearby tissues and structures. As the disease advances, it may lead to symptoms such as difficulty swallowing, changes in voice, or swelling in the neck. The cancer can spread to nearby lymph nodes and, in some cases, to distant parts of the body. The progression and symptoms can vary depending on the specific location and extent of the recurrence.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520264-33-00Protocol codeRePaIr-HNEstimated enrolment204 patientsSponsorUniversitaet Des Saarlandes

sourced from the EU Clinical Trials Register and site verification

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