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Study on the Safety and Tolerance of Durvalumab and Radiotherapy for Patients with Untreated Head and Neck Squamous Cell Carcinoma

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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 squamous cell carcinoma of the head and neck. This cancer affects areas such as the mouth, throat, and voice box. The study is testing a treatment that combines a medication called durvalumab (also known by its code name MEDI4736) with radiotherapy, which is a treatment that uses high-energy rays to target and kill cancer cells. The purpose of the study is to evaluate how well this combination works in controlling the cancer in the neck area without using additional radiation in areas that do not show signs of cancer.

Participants in the study will receive the treatment over a period of time, with regular check-ups to monitor their health and the cancer's response to the treatment. The study will look at how well the treatment controls the cancer in the neck and whether it causes any side effects. The study will also assess the overall health and survival of the participants, as well as their quality of life during and after the treatment.

This trial is important for understanding the effectiveness and safety of combining durvalumab with radiotherapy for treating squamous cell carcinoma of the head and neck. The results could help improve treatment options for patients with this type of cancer in the future.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, health status, and type of cancer. The study focuses on untreated squamous cell carcinoma of the head and neck.

    The patient must be over 18 years old and meet certain health conditions, including specific performance status and medical history.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of durvalumab and radiotherapy. Durvalumab is administered as a solution for infusion, which means it is given through a drip into a vein.

    The specific dosage and frequency of durvalumab administration are determined by the medical team based on individual patient needs and study protocols.

  3. Step 3

    Radiotherapy

    Radiotherapy targets the tumor site, including the primary tumor and affected lymph nodes. The treatment does not include prophylactic irradiation of unaffected neck regions.

    The aim is to control the cancer locally and regionally, focusing on the neck area.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, the patient's response to treatment is closely monitored. This includes assessing the control of cancer in the neck region and observing any side effects.

    Regular follow-ups are scheduled to evaluate the patient's health status and the effectiveness of the treatment. These follow-ups occur at baseline, 3, 12, and 24 months after radiotherapy.

  5. Step 5

    Study completion

    The study is expected to conclude by July 2026. The primary goal is to assess the control of cancer in the neck region one year after treatment.

    Secondary outcomes include evaluating side effects, overall survival, and quality of life scores.

Who can join the trial?

10 criteria

  • Must be over 18 years old, with no upper age limit.
  • Must have a **Performance Status ECOG** between 0 and 2. This is a scale that measures how well a person can perform daily activities.
  • Must have **squamous cell carcinoma** that has not been treated before. This is a type of cancer that affects certain cells in the body.
  • Must have a tumor classified as T1 to T4 with specific clinical statuses (N0-N1, N2a, or N2b) and only one affected lymph node on the same side as the tumor, as seen in imaging tests.
  • Must meet at least one of these fragility criteria:
    • **ECOG Status** of 1 with multiple other health issues, at least two of which are moderate to severe (affecting kidneys, heart, blood vessels, liver, nerves, or lungs).
    • **ECOG Status** of 2.
    • Age 70 or older, considered unfit by a special geriatric evaluation or unable to receive certain chemotherapy drugs (cisplatin or carboplatin-5FU) due to specific health criteria.
    • The cancer must be located in the oral cavity, oropharynx, hypopharynx, or larynx.
    • Must have documentation of **p16 disease**, which is related to HPV status for tumors in the oropharynx.
    • Must have a **glomerular filtration rate (GFR)** greater than 40 mL/min/1.73m² or a calculated **creatinine clearance** greater than 40 mL/min. These are measures of kidney function.

Who cannot join the trial?

1 criterion

  • Having an untreated squamous cell carcinoma of the head and neck. This means the type of cancer in the head and neck area has not been treated yet.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It works by blocking a specific protein that can stop the immune system from attacking cancer cells. In this study, it is combined with radiotherapy to treat squamous cell carcinoma of the head and neck.

  • Radiotherapy

    is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, radiotherapy is directed at the tumor site, including the primary tumor and the affected lymph nodes, to help control the spread of cancer in the head and neck area.

What is already known about the treatment

Durvalumab – Durvalumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently being studied in clinical trials for its effectiveness in treating squamous cell carcinoma of the head and neck, particularly in combination with radiotherapy. The main therapeutic indication for durvalumab is to enhance the body's immune response against cancer cells. At the molecular level, durvalumab works by blocking the PD-L1 protein, which can help the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of immunotherapy used in cancer treatment.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that begins in the squamous cells, which are flat cells found in the lining of the head and neck region. It typically affects areas such as the mouth, throat, and nose. The disease progresses by forming tumors that can invade nearby tissues and spread to lymph nodes in the neck. As it advances, it may cause symptoms like a persistent sore throat, difficulty swallowing, or a lump in the neck. The progression can vary, with some cases remaining localized while others may spread to distant parts of the body. Early detection and monitoring are crucial for managing the disease's progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513977-31-00Protocol codeGORTEC 2018-02Estimated enrolment61 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).