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Study of Carboplatin, Paclitaxel, and Cetuximab for Patients with Recurrent or Metastatic Head and Neck Cancer After Pembrolizumab Treatment Failure

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 squamous cell carcinoma. This cancer affects areas such as the mouth, throat, and voice box. The study is investigating a combination of treatments for patients whose cancer has returned or spread after initial treatment with a drug called Pembrolizumab. The treatments being tested in this study include three medications: Carboplatin, Paclitaxel, and Cetuximab. These medications are given as solutions through a vein, a method known as intravenous infusion.

The purpose of the study is to see how well this combination of treatments works in patients who have not responded to their first treatment. Participants in the study will receive the combination of Carboplatin, Paclitaxel, and Cetuximab over a period of time. The study will monitor how the cancer responds to these treatments and will also keep track of any side effects that may occur. The study aims to understand the effectiveness of this treatment combination in managing the cancer and improving patient outcomes.

Throughout the study, researchers will collect information on how the cancer progresses and how patients are doing overall. This includes looking at whether the cancer shrinks or grows, and how long patients live after starting the treatment. The study will also gather information on any side effects experienced by the patients. This information will help doctors understand if this treatment combination is a good option for patients with head and neck squamous cell carcinoma who have not had success with their initial treatment.

The research process

The trial runs in 6 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, tumor progression, and diagnosis of head and neck squamous cell carcinoma.

    The study is designed for patients who have experienced progression after initial treatment with pembrolizumab, with or without chemotherapy.

  2. Step 2

    Treatment initiation

    The treatment involves a combination of three medications: cetuximab, paclitaxel, and carboplatin.

    These medications are administered through an intravenous infusion, which means they are given directly into a vein.

  3. Step 3

    Medication administration

    Cetuximab is provided as a 5 mg/mL solution for infusion.

    Paclitaxel is given as a 6 mg/mL solution to be diluted for infusion.

    Carboplatin is administered as a 10 mg/mL solution for injection or infusion.

  4. Step 4

    Treatment schedule

    The treatment schedule and dosage are determined by the healthcare provider based on individual patient needs and response to the treatment.

    The duration of the treatment is aligned with the study's objectives and patient response.

  5. Step 5

    Monitoring and follow-up

    Patients are monitored for objective response rates, which assess the effectiveness of the treatment.

    Progression events and patient condition are tracked beyond 12 months of participation.

    Adverse events and serious adverse events are recorded according to established criteria.

  6. Step 6

    Completion of study participation

    The study is expected to continue until September 2029, with patient participation extending as needed based on individual treatment response and study requirements.

    Patient-reported outcomes are collected using specific questionnaires to assess quality of life.

Who can join the trial?

11 criteria

  • Must be **18 years or older**.
  • Must have a **tumor** that has grown or spread, as shown by medical tests.
  • Must have the correct **biology**, meaning the right type of cancer cells.
  • Must have a confirmed diagnosis of **invasive squamous cell carcinoma** in the head and neck. This means a specific type of cancer in these areas.
  • Cancer must be in one of these areas: **oral cavity** (mouth), **oropharynx** (part of the throat behind the mouth), **larynx** (voice box), or **hypopharynx** (lower part of the throat). The **p16 status** should be known for oropharynx cancer, which is a specific test result related to the cancer.
  • Cancers in the head and neck with an **unknown primary origin** are accepted. This means the starting point of the cancer is not known.
  • Must have **metastatic** (stage IVc) or **recurrent disease**. This means the cancer has spread to other parts of the body or has come back after treatment, and surgery or radiation cannot cure it.
  • Must need a **second line of treatment** after using **pembrolizumab** (a type of cancer treatment) with or without chemotherapy.
  • Must have had a break from **chemotherapy** for at least **3 months**.
  • Must have an **ECOG Performance Index** of 0, 1, or 2. This is a scale that measures how well a person can perform daily activities, with 0 being fully active and 2 being able to do some activities but not work.
  • Must have a **life expectancy** of at least **12 weeks**.

Who cannot join the trial?

4 criteria

  • Patients who have not been diagnosed with head and neck squamous cell carcinoma. This is a type of cancer that occurs in the head and neck region.
  • Patients who have not experienced a recurrence or spread of their cancer after treatment with Pembrolizumab. Pembrolizumab is a medication used to treat certain types of cancer.
  • Patients who are not in the age range specified for the study. The study includes certain age groups, and patients outside these groups cannot participate.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

  • Carboplatin

    is a chemotherapy medication used to treat various types of cancer. In this trial, it is used to help stop the growth of cancer cells in patients with head and neck squamous cell carcinoma who did not respond to initial treatment.

  • Paclitaxel

    is another chemotherapy drug that works by stopping cancer cells from dividing and growing. It is used in combination with other medications to treat patients with head and neck cancer that has returned or spread after initial treatment.

  • Cetuximab

    is a targeted therapy that works by blocking a protein on the surface of cancer cells, which can slow down or stop their growth. It is used in this trial to treat patients with head and neck cancer that has not responded to previous treatments.

  • Pembrolizumab

    is an immunotherapy drug that helps the immune system recognize and attack cancer cells. It is used as a first-line treatment for head and neck squamous cell carcinoma, but this trial focuses on patients who did not respond to it.

What is already known about the treatment

  • Carboplatin

    This medication is administered intravenously and is used in the treatment of various cancers, including head and neck squamous cell carcinoma. It is currently well-established in medical practice and literature as a chemotherapy agent. Carboplatin works by interfering with the DNA of cancer cells, preventing them from dividing and growing. It belongs to the pharmacological class of platinum-based antineoplastic agents.

  • Paclitaxel

    Administered through an intravenous infusion, Paclitaxel is used to treat several types of cancer, including head and neck squamous cell carcinoma. It is widely recognized in medical literature as an effective chemotherapy drug. Paclitaxel acts by stabilizing the structure of microtubules, which are essential for cell division, thereby inhibiting the growth of cancer cells. It is classified as a mitotic inhibitor.

  • Cetuximab

    This medication is given by intravenous infusion and is used to treat head and neck squamous cell carcinoma, among other cancers. It is well-documented in medical literature as a targeted therapy. Cetuximab works by blocking the epidermal growth factor receptor (EGFR) on the surface of cancer cells, which is involved in their growth and survival. It is classified as a monoclonal antibody.

Investigated diseases

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth that can spread to nearby tissues and lymph nodes. As the disease progresses, it may lead to symptoms like a persistent sore throat, difficulty swallowing, or changes in voice. The cancer can further metastasize to distant parts of the body, complicating the condition. Environmental factors like tobacco and alcohol use are significant risk factors. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512297-96-01Estimated enrolment46 patientsSponsorCentre Regional Lutte Contre Le Cancer

sourced from the EU Clinical Trials Register and site verification

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