Recruiting

Study of Cetuximab and Avelumab for Patients with Recurrent or Metastatic Head and Neck Cancer with PD-L1 Score 1 or Higher

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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 (HNSCC). This cancer affects areas such as the mouth, throat, and voice box and has returned or spread to other parts of the body. The study will use a combination of treatments, including cetuximab and avelumab, which are medications given through an intravenous infusion, meaning they are delivered directly into the bloodstream through a vein. Cetuximab is a protein-based medication, while avelumab is a type of human monoclonal antibody, which is a protein made in a lab that can bind to substances in the body, including cancer cells.

The purpose of the study is to evaluate if the combination of cetuximab with platinum and taxane-based chemotherapy, followed by maintenance therapy with avelumab and cetuximab, can improve the progression-free survival of patients. Progression-free survival refers to the length of time during and after treatment that a patient lives with the disease without it getting worse. The study will involve a single group of participants who will receive this treatment sequence. The treatment period is expected to last up to 12 months.

Participants in the study will first receive cetuximab along with chemotherapy drugs that include platinum and taxane. After this initial treatment phase, they will continue with maintenance therapy using avelumab and cetuximab. The study aims to see if this approach can increase the percentage of patients who remain free from disease progression at six months. The study will also look at overall survival, response rates, and the safety of the treatment. This trial is designed to help understand if this combination of treatments can be more effective for patients with this type of cancer.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial treatment phase
Upon joining the study, the initial treatment involves receiving a combination of medications. These include cetuximab, a medication given through an intravenous infusion, which means it is administered directly into a vein. The dosage is 5 mg/mL.
Alongside cetuximab, a combination of platinum and taxane-based chemotherapy is administered. This phase is designed to target the cancer cells effectively.
Step 2
Maintenance therapy
Following the initial treatment phase, the next step is the maintenance therapy. This involves the administration of avelumab and cetuximab.
Avelumab is also given through intravenous administration. The purpose of this phase is to maintain the progress achieved during the initial treatment and to help prevent the cancer from returning or worsening.
Step 3
Progress monitoring
Throughout the trial, regular monitoring is conducted to assess the response to the treatment. This includes various tests and evaluations to check the status of the cancer and overall health.
The primary goal is to evaluate the progression-free survival at six months, which means checking if the cancer has not worsened during this period.
Step 4
Completion and follow-up
Upon completion of the treatment phases, follow-up appointments are scheduled to continue monitoring health and any long-term effects of the treatment.
These follow-ups are crucial to ensure any changes in health are addressed promptly and to gather data on the overall effectiveness of the treatment.

Who can join the trial?

15 criteria

Must be able to sign a consent form and be at least 18 years old.
Must have a confirmed diagnosis of head and neck squamous cell carcinoma (HNSCC) that has come back or spread to other parts of the body.
The cancer must be in areas like the oral cavity, oropharynx, larynx, or hypopharynx and not suitable for treatment aimed at curing it.
Must have a PD-L1 CPS score between 1 and 19. This is a test that helps understand how the cancer might respond to certain treatments.
Must have measurable disease according to specific criteria used by doctors to assess cancer.
Must not have had previous systemic therapy (treatment that affects the whole body) for recurrent or metastatic HNSCC.
Previous systemic therapy is allowed if it was completed more than 6 months before signing the consent and was part of a treatment plan for locally advanced disease.
Must have an ECOG Performance Status of 0-1, which means being fully active or restricted in physically strenuous activity but able to carry out light work.
Must have adequate liver function, which means certain liver tests must be within specific limits.
Must have adequate kidney function, with a creatinine clearance of at least 30 mL/min. This is a test to see how well the kidneys are working.
Must have adequate bone marrow function, which means having enough blood cells like neutrophils, platelets, and hemoglobin.
Must have tissue samples of the disease available for study.
Must provide blood samples as required by the study protocol.
Palliative radiotherapy or surgery within 4 weeks before joining the study is allowed.
If experiencing certain symptoms like nerve damage or hearing issues, or if kidney function is below a certain level, treatment with carboplatin is required instead of cisplatin.

Who cannot join the trial?

10 criteria

Patients with other types of cancer that are not recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) cannot participate.
Patients who have had a different cancer treatment within the last 4 weeks are not eligible.
Patients with severe heart problems are excluded.
Patients with uncontrolled infections cannot join the study.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients with a history of severe allergic reactions to similar drugs used in the study are excluded.
Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
Patients who have received an organ transplant cannot participate.
Patients with a history of drug or alcohol abuse in the past 6 months are excluded.
Patients with any other medical condition that the study doctors think would make it unsafe for them to participate are not eligible.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
Verified
Palermo, Italy
Azienda Ospedaliero Universitaria Careggi
Responsive
Florence, Italy
Istituto Oncologico Veneto
Responsive
Padua, Italy

Trial locations

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Investigated drugs

Cetuximab
is a medication used in this trial to help treat head and neck cancer. It works by targeting a specific protein on the surface of cancer cells, which can slow down or stop the growth of these cells. This medication is often used in combination with other treatments to improve its effectiveness.
Avelumab
is another medication used in the trial. It is a type of immunotherapy, which means it helps your immune system fight cancer. Avelumab works by blocking a protein that cancer cells use to hide from the immune system, allowing your body to better recognize and attack the cancer cells.
Platinum-based chemotherapy
refers to a group of cancer-fighting drugs that contain the metal platinum. These medications work by damaging the DNA of cancer cells, which can prevent them from growing and dividing. They are commonly used in combination with other treatments to enhance their cancer-fighting effects.
Taxane-based chemotherapy
is a type of cancer treatment that includes drugs like paclitaxel and docetaxel. These medications work by interfering with the normal function of microtubules in cells, which are structures that help cells divide. By disrupting these structures, taxane-based chemotherapy can stop cancer cells from growing and spreading.

What is already known about the treatment

Cetuximab
Cetuximab is administered intravenously, meaning it is given directly into a vein through an IV. It is currently used in medicine to treat certain types of cancer, including head and neck squamous cell carcinoma (HNSCC). The main therapeutic indication for cetuximab in this trial is for patients with recurrent or metastatic head and neck cancer. At the molecular level, cetuximab works by blocking a protein called the epidermal growth factor receptor (EGFR), which is involved in the growth and spread of cancer cells. It is classified as a monoclonal antibody, a type of targeted cancer therapy.
Avelumab
Avelumab is also administered intravenously, similar to cetuximab. It is an immunotherapy drug used in the treatment of various cancers, including head and neck squamous cell carcinoma (HNSCC) in this trial. The main therapeutic indication for avelumab is to help the immune system recognize and attack cancer cells. At the molecular level, avelumab works by blocking a protein called PD-L1, which cancer cells use to hide from the immune system. It is classified as a checkpoint inhibitor, a type of immunotherapy that helps the immune system fight cancer.

Investigated diseases

Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma – This disease is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It is characterized by the recurrence of cancer after initial treatment or its spread to other parts of the body, known as metastasis. The progression involves the uncontrolled growth of abnormal cells, which can invade nearby tissues and organs. As the disease advances, it may cause symptoms such as difficulty swallowing, persistent sore throat, and changes in voice. The cancer can spread to lymph nodes in the neck and potentially to distant organs. The progression and symptoms can vary depending on the specific location and extent of the cancer.