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A Study of Amivantamab With Carboplatin and Pembrolizumab 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 study involves people with head and neck squamous cell carcinoma that has come back or spread to other parts of the body and cannot be cured with surgery or radiation alone. The study will test a medication called JNJ-61186372, which contains amivantamab, given together with two other cancer medications called carboplatin and pembrolizumab. This combination will be compared to a standard treatment that includes either cisplatin or carboplatin, along with pembrolizumab and fluorouracil, which is also known as 5-FU. All of these medications are given through a vein into the bloodstream, except for JNJ-61186372 which is given as an injection under the skin. The study is designed for people who have not yet received any systemic treatment for their cancer after it has come back or spread.

The purpose of the study is to compare how well the different treatment combinations work against the cancer. Participants will be randomly assigned to receive either the new combination with JNJ-61186372 or the standard treatment. During the study, doctors will monitor how the cancer responds to treatment and track how long participants live. They will also check for any side effects or problems that might occur with the treatments.

Throughout the study, participants will have regular check-ups where doctors will measure the size of the cancer using imaging scans and assess overall health. The study will also look at quality of life and symptoms by asking participants to complete questionnaires about how they are feeling and how the treatment affects their daily activities. Blood samples will be collected to measure medication levels in the body and to check for any immune responses to the treatment. The study will continue for several years to fully understand the long-term effects of these treatment combinations.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    Upon entering the study, you will be randomly assigned to one of two treatment groups. This process is called randomization and determines which combination of medications you will receive.

    One group will receive amivantamab combined with carboplatin and pembrolizumab.

    The other group will receive the standard treatment consisting of a platinum-based medication with pembrolizumab and fluorouracil (also known as 5-FU).

  2. Step 2

    Medication administration

    If you are assigned to the first treatment group, you will receive amivantamab as an injection under the skin (subcutaneous injection), along with carboplatin and pembrolizumab, both given through a vein (intravenous infusion).

    If you are assigned to the second treatment group, you will receive a platinum-based medication (either cisplatin or carboplatin) through a vein, combined with pembrolizumab and fluorouracil, also given through a vein.

    The specific dosage, frequency, and duration of each medication will be determined by the study protocol and your medical condition.

  3. Step 3

    Regular monitoring and assessments

    Throughout the study, you will undergo regular medical examinations to monitor your health and the effects of the treatment.

    These assessments will include measurements of your tumor size according to RECIST v1.1, which is a standardized method for evaluating how tumors respond to treatment.

    Blood samples will be collected to measure medication levels in your system and to check for any laboratory abnormalities.

    Your blood will also be tested for anti-amivantamab antibodies, which are substances your body might produce in response to the medication.

  4. Step 4

    Quality of life evaluations

    You will be asked to complete questionnaires at regular intervals to assess your symptoms and quality of life.

    These questionnaires include the EORTC QLQ-HN43, which focuses on symptoms specific to head and neck cancer, and the EORTC QLQ-C30, which evaluates general cancer-related symptoms and functioning.

    Another questionnaire called EORTC IL46 will assess treatment tolerability.

    These evaluations help track changes in your symptoms and overall well-being during the study.

  5. Step 5

    Safety monitoring

    Your health will be closely monitored for any side effects or adverse events related to the study medications.

    Any new symptoms, changes in your condition, or laboratory test abnormalities will be recorded and evaluated for their severity.

    This ongoing safety monitoring continues throughout your participation in the study.

  6. Step 6

    Tumor response evaluation

    Imaging scans will be performed at specified intervals to evaluate how your tumor is responding to treatment.

    These scans will be reviewed both by your study doctor and by an independent group of experts called BICR (Blinded Independent Central Review).

    The evaluations will measure progression-free survival (the time during which your disease does not worsen), overall response rate (whether your tumor shrinks), and duration of response (how long any positive response lasts).

  7. Step 7

    Continuation of treatment

    You will continue receiving the assigned treatment according to the study schedule until your disease progresses, you experience unacceptable side effects, or you decide to withdraw from the study.

    The study protocol will specify the exact timing and frequency of medication administration, assessments, and follow-up visits.

  8. Step 8

    Long-term follow-up

    After completing the treatment phase, you will continue to be followed for long-term outcomes.

    The primary outcome being measured is overall survival, which refers to the length of time you remain alive after starting the study treatment.

    This follow-up period is an essential part of the study and may continue for an extended period.

Who can join the trial?

6 criteria

  • You must have head and neck squamous cell carcinoma (a type of cancer that affects the head and neck area) that has come back after treatment or has spread to other parts of the body, confirmed by laboratory tests of tissue or cells
  • Your cancer cannot be cured by treatments that target only the affected area, such as surgery or radiation
  • You have not received any treatment with medications that work throughout your whole body for your cancer that has come back or spread
  • You must be 18 years of age or older
  • You must have an ECOG score of 0 or 1, which is a measure of how well you can perform daily activities (0 means you are fully active and 1 means you have some restrictions but can still do light work)
  • Your cancer must be measurable on scans according to specific guidelines called RECIST version 1.1, which means doctors can track changes in the size of your tumors

Who cannot join the trial?

1 criterion

  • No specific exclusion criteria (reasons why you cannot join the study) have been provided in the available study information.
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Investigated drugs

  • Amivantamab

    is a medication that is being tested in this clinical trial. It is given together with other cancer treatments to see if it can help fight cancer in patients with head and neck cancer that has spread or come back.

  • Carboplatin

    is a chemotherapy medication that works by stopping cancer cells from growing and dividing. It is a standard treatment used to kill cancer cells in various types of cancer.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's immune system recognize and attack cancer cells. It works by blocking a protein that prevents the immune system from fighting the cancer.

  • 5-FU

    is a chemotherapy medication that interferes with the growth of cancer cells and slows their growth and spread in the body. It is commonly used to treat different types of cancers.

What is already known about the treatment

  • Amivantamab

    Amivantamab is a medication given through an intravenous infusion (directly into a vein) and is being studied in clinical trials for the treatment of head and neck squamous cell carcinoma that has spread or come back after previous treatment. This drug works by targeting two specific proteins on cancer cells called EGFR and MET, which help cancer cells grow and survive; by blocking these proteins, the medication helps slow down or stop the growth of cancer cells. It belongs to a class of medications called bispecific antibodies, which are designed to attach to two different targets on cancer cells at the same time, making them more effective at fighting cancer.

  • Carboplatin

    Carboplatin is a chemotherapy medication administered through an intravenous infusion (directly into a vein) and is widely used in cancer treatment, including head and neck cancers. This drug works by damaging the DNA inside cancer cells, which prevents them from dividing and growing, ultimately leading to their death. It belongs to a class of chemotherapy drugs called platinum-based agents, which are among the most commonly used medications for treating various types of cancer.

  • Pembrolizumab

    Pembrolizumab is an immunotherapy medication given through an intravenous infusion (directly into a vein) and is approved for treating several types of cancer, including head and neck squamous cell carcinoma. This drug works by blocking a protein called PD-1 on immune cells, which allows the body's immune system to recognize and attack cancer cells more effectively. It belongs to a class of medications called immune checkpoint inhibitors, which help the immune system fight cancer by removing the brakes that prevent it from attacking tumor cells.

  • 5-FU (Fluorouracil)

    5-FU, also known as fluorouracil, is a chemotherapy medication that can be given through an intravenous infusion (directly into a vein) and is commonly used to treat head and neck cancers along with other types of cancer. This drug works by interfering with the production of DNA and RNA in cancer cells, which are essential building blocks that cells need to grow and multiply, thereby stopping cancer cells from dividing. It belongs to a class of chemotherapy drugs called antimetabolites, which mimic natural substances in the body but disrupt normal cell growth processes.

Investigated diseases

  • Recurrent Head and Neck Squamous Cell Carcinoma

    This is a type of cancer that comes back after initial treatment in the head and neck region. The disease develops from squamous cells, which are flat cells that line the surfaces of the mouth, throat, voice box, nose, and salivary glands. When the cancer recurs, it means that cancer cells have returned to the same area where the original tumor was located or nearby tissues. The disease can progress by growing locally in surrounding tissues or spreading through the lymphatic system to nearby lymph nodes. Recurrent tumors may be more difficult to manage than the original cancer because they have already survived one course of treatment.

  • Metastatic Head and Neck Squamous Cell Carcinoma

    This is an advanced form of cancer that originates in the squamous cells of the head and neck area and has spread to distant parts of the body. The cancer cells travel through the bloodstream or lymphatic system to form new tumors in organs far from the original site, such as the lungs, liver, or bones. This represents a more advanced stage of the disease compared to cancer that remains localized. The progression involves cancer cells breaking away from the primary tumor, entering blood vessels or lymph channels, and establishing new growth sites in distant organs. As the disease advances, multiple organ systems may become affected by these secondary tumors.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521917-24-00Protocol code61186372HNC3001Estimated enrolment500 patientsSponsorJanssen Cilag International

sourced from the EU Clinical Trials Register and site verification

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