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Study on the Effects of Tepotinib and Cetuximab for Patients with Platinum-Resistant Head and Neck Cancer After Immunotherapy Relapse

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 a type of cancer known as head and neck cancer, specifically in patients whose cancer has returned or worsened after receiving immunotherapy and who are resistant to platinum-based treatments. The study will explore the effects of a combination of two medications: cetuximab and tepotinib. Cetuximab is given as a solution through an infusion, which means it is administered directly into the bloodstream, while tepotinib is taken orally in the form of a tablet.

The purpose of this study is to evaluate how well the combination of these two drugs works in terms of reducing the size of the tumor. Participants in the study will receive both medications over a period of up to 12 months. The study is designed to observe the response of the cancer to this treatment combination, which targets specific proteins involved in cancer growth.

This trial is open-label, meaning that both the researchers and participants will know which treatments are being administered. The study is being conducted at multiple centers, allowing for a broader range of participants. The goal is to gather information on the effectiveness of this treatment combination in managing head and neck cancer that has not responded to previous therapies.

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 verifying age, medical history, and specific cancer characteristics.

    Eligibility criteria include being over 18 years old and having a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) that is resistant to platinum-based treatments.

  2. Step 2

    Treatment initiation

    The treatment phase begins with the administration of two medications: cetuximab and tepotinib.

    Cetuximab is given through an infusion, which involves receiving the medication directly into the bloodstream via a vein.

    Tepotinib is taken orally, meaning it is consumed by mouth in the form of a pill or liquid.

  3. Step 3

    Treatment schedule

    The specific dosage and frequency of cetuximab and tepotinib are determined by the study protocol and will be explained by the healthcare team.

    The duration of the treatment phase is aligned with the study's objectives, focusing on evaluating the tumor's response to the medication combination.

  4. Step 4

    Monitoring and evaluation

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes physical examinations, imaging tests, and laboratory tests.

    The primary goal is to observe the tumor's response, which is measured by criteria such as complete or partial response.

  5. Step 5

    Completion of study

    The study is estimated to conclude by May 31, 2026. At this point, a final evaluation is conducted to summarize the treatment outcomes.

    Participants will receive information about their health status and any further steps if necessary.

Who can join the trial?

7 criteria

  • Must be an adult over 18 years old.
  • Must have a confirmed diagnosis of head and neck cancer. This includes cancer from any primary site in the head and neck area, such as the nasopharynx (the upper part of the throat behind the nose) and paranasal sinuses (air-filled spaces around the nose). It also includes squamous cell carcinoma (a type of skin cancer) of unknown origin, as long as it is related to the head and neck.
  • Must have recurrent (cancer that has come back) or metastatic (cancer that has spread to other parts of the body) disease. This means the cancer must meet at least one of the following conditions:
    • The disease cannot be cured by surgery or radiation, as determined by a doctor.
    • The cancer has spread to other parts of the body (referred to as M1 disease).
    • The disease has not improved or has worsened after treatment aimed at curing it, and surgery is not an option because it cannot cure the disease or would cause too many problems. Patients who choose not to have major surgery are also eligible.
    • For patients with cancer in the oropharynx (part of the throat behind the mouth) or with an unknown primary site, the cancer must not be related to human papillomavirus (HPV). This is determined by tests such as p16 immunohistochemistry, where a tumor is considered p16-positive if at least 70% of the tumor cells show specific staining.
    • For patients with nasopharyngeal cancer or an unknown primary site, the cancer must not be related to Epstein-Barr Virus (EBV).

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than head and neck cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not able to give informed consent or understand the study requirements cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
  • Patients who have had a recent major surgery or are recovering from surgery cannot participate.
  • Patients who have allergies or reactions to the study medications cannot participate.
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Investigated drugs

  • Tepotinib

    is a medication used in this trial to target and inhibit the c-MET receptor, which can be involved in the growth and spread of cancer cells. By blocking this receptor, tepotinib may help slow down or stop the progression of the cancer.

  • Cetuximab

    is another medication used in the trial, which targets the EGFR (epidermal growth factor receptor). This receptor is often overactive in certain types of cancer, leading to tumor growth. Cetuximab works by blocking this receptor, potentially reducing the growth and spread of cancer cells.

What is already known about the treatment

  • Tepotinib

    This medication is administered orally and is currently being studied in clinical trials for its effectiveness in treating head and neck cancer, specifically in patients who have not responded to platinum-based chemotherapy and have relapsed after immunotherapy. Tepotinib is a c-MET inhibitor, which means it works by blocking the c-MET receptor, a protein that can promote cancer cell growth when overactive. It is classified as a targeted cancer therapy, aiming to interfere with specific molecules involved in tumor growth and progression.

  • Cetuximab

    This medication is given through an intravenous infusion and is used in combination with tepotinib in clinical trials for head and neck cancer. Cetuximab is an EGFR inhibitor, which means it targets the epidermal growth factor receptor, a protein on the surface of cells that, when activated, can lead to cancer cell proliferation. By blocking this receptor, cetuximab helps to slow down or stop the growth of cancer cells. It is classified as a monoclonal antibody used in targeted cancer therapy.

Investigated diseases

Head and Neck Cancer – This type of cancer originates in the squamous cells that line the moist surfaces inside the head and neck, such as the mouth, throat, and nose. It often begins as a small, painless growth or sore that does not heal. As it progresses, it may cause symptoms like a persistent sore throat, difficulty swallowing, or changes in voice. The cancer can spread to nearby tissues, including lymph nodes, and may eventually affect other parts of the body. Early stages might not show noticeable symptoms, making regular check-ups important for detection. The progression can vary depending on the specific location and type of cells involved.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518892-72-00Protocol codeTEPMEETCETEstimated enrolment30 patientsSponsorAzienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia

sourced from the EU Clinical Trials Register and site verification

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