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Study of Amivantamab, Pembrolizumab, and Paclitaxel for Patients with Recurrent or Metastatic 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 Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma. This is a condition where cancer cells form in the tissues of the head and neck and have either returned after treatment or spread to other parts of the body. The study will explore the effects of a treatment called Amivantamab, both on its own and in combination with other treatments. These combinations include Pembrolizumab, a medication that helps the immune system fight cancer, and Paclitaxel, a chemotherapy drug that stops cancer cells from growing.

The purpose of the study is to understand how well these treatments work against the cancer and to learn more about their safety. Participants will be divided into different groups, or cohorts, to receive different treatment combinations. Some participants will receive Amivantamab alone, while others will receive it with Pembrolizumab or Paclitaxel. The study will also include a group that receives a placebo, which is a substance with no active medication, to compare the effects of the treatments.

Throughout the study, participants will receive their assigned treatments and be monitored for any changes in their cancer and any side effects they may experience. The study aims to gather information over a period of time to determine the effectiveness and safety of these treatment combinations for people with this type of cancer. The study is expected to continue until 2026, providing valuable insights into potential new treatment options for this challenging condition.

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, the participant will be assigned to one of the cohorts based on their medical history and current condition.

    The study focuses on individuals with recurrent or metastatic head and neck squamous cell carcinoma.

  2. Step 2

    Treatment administration

    Participants will receive treatments based on their assigned cohort.

    Cohort 1 involves amivantamab monotherapy, administered through intravenous use.

    Cohort 2 involves a combination of amivantamab and pembrolizumab, both administered intravenously.

    Cohort 3A and 3B involve amivantamab in addition to paclitaxel, with amivantamab administered subcutaneously and paclitaxel intravenously.

  3. Step 3

    Treatment schedule

    The frequency and duration of the treatment will depend on the specific cohort and the participant's response to the treatment.

    Regular monitoring and assessments will be conducted to evaluate the treatment's effectiveness and any side effects.

  4. Step 4

    Monitoring and assessments

    Participants will undergo regular health assessments to monitor the progress of the treatment.

    These assessments will include physical examinations, blood tests, and imaging studies to evaluate the tumor's response.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by July 2026.

    Upon completion, participants will have a final assessment to determine the overall impact of the treatment.

Who can join the trial?

15 criteria

  • Must be at least 18 years old or older, depending on the legal age in the area where the study is conducted.
  • Must have a confirmed diagnosis of **Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma** (R/M HNSCC) that cannot be cured with local treatments. This includes tumors in the oropharynx, oral cavity, hypopharynx, or larynx. If the tumor is in the oropharynx, a specific test result called **p16 status** must be negative.
  • Must have certain lab values within specific limits, such as:
    • **AST** and **ALT** (liver enzymes) should be no more than 3 times the upper limit of normal (ULN), or 5 times if there are liver metastases.
    • **Total bilirubin** should be no more than 1.5 times the ULN, unless the participant has a condition like Gilbert's syndrome, in which case the conjugated bilirubin should be normal.
    • Must have adequate organ and bone marrow function, which includes:
      • **Hemoglobin** of at least 9 grams per deciliter (g/dL).
      • **Neutrophils** (a type of white blood cell) of at least 1.5 x 10^3 per microliter (µL).
      • **Platelets** of at least 100 x 10^3 per microliter (µL).
      • Must have a performance status of 0 to 1 on the **ECOG scale**, which measures daily living abilities.
      • Must have at least one of the following kidney function indicators:
        • **Serum creatinine** no more than 1.5 times the ULN.
        • **Estimated glomerular filtration rate** (eGFR) of at least 45 mL/min.
        • Must provide a tumor tissue sample for testing, if available. If not, a new biopsy may be required.
        • Must have resolved any side effects from previous cancer treatments to a mild level or to the level they were before treatment, except for hair loss or skin changes from radiation, and certain nerve or thyroid issues.
        • May have another cancer, as long as it does not interfere with the study treatment or outcomes.
        • Must meet specific requirements for different groups in the study, such as:
          • For some groups, must have received certain previous treatments and shown disease progression.
          • For others, must not have received certain treatments before or must be new to treatment in the recurrent/metastatic setting.

Who cannot join the trial?

5 criteria

  • Patients who have not received prior treatment with platinum-based chemotherapy and a PD-1/PD-L1 inhibitor cannot participate. **Platinum-based chemotherapy** is a type of cancer treatment using drugs that contain the metal platinum. **PD-1/PD-L1 inhibitors** are medicines that help the immune system fight cancer.
  • Patients who have already received treatment in the recurrent/metastatic setting cannot participate in Cohort 2. **Recurrent/metastatic** means that the cancer has come back or spread to other parts of the body.
  • Patients who have not received PD-1/PD-L1 based therapy cannot participate in Cohorts 3A and 3B.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, but certain vulnerable populations may be excluded. **Vulnerable populations** refer to groups of people who may need special protection or care.
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Investigated drugs

  • Amivantamab

    is a medication being studied for its ability to fight cancer in patients with head and neck squamous cell carcinoma that has come back or spread. It is being tested both on its own and in combination with other treatments to see how well it works against tumors.

  • Pembrolizumab

    is another medication used in this study. It is combined with amivantamab to see if the two together can better treat patients who have not yet received treatment for their recurrent or metastatic head and neck cancer.

  • Paclitaxel

    is a chemotherapy drug included in the study. It is used alongside amivantamab to determine if this combination is safe and effective for patients who have already been treated with certain other cancer therapies.

What is already known about the treatment

Amivantamab – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating recurrent or metastatic head and neck squamous cell carcinoma. It is primarily used for patients who have previously undergone treatment with platinum-based chemotherapy and PD-1/PD-L1 inhibitors. Amivantamab works by targeting specific proteins on cancer cells, helping the immune system to recognize and destroy these cells. It is classified as a monoclonal antibody, which is a type of targeted cancer therapy.

Investigated diseases

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the head and neck region. It is characterized by its ability to recur after initial treatment or spread to other parts of the body, known as metastasis. The disease often begins in areas such as the mouth, throat, or larynx and can progress to involve nearby tissues and lymph nodes. As it advances, it may cause symptoms like difficulty swallowing, persistent sore throat, or changes in voice. The progression of this carcinoma can vary, with some cases remaining localized while others spread more extensively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-508418-40-00Protocol code61186372HNC2002Estimated enrolment275 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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