Study of avelumab and cetuximab combination treatment after TPEx chemotherapy for patients with recurrent or metastatic head and neck cancer receiving first-line therapy

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What is this study about?

This study focuses on patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck, a type of cancer that has either returned after initial treatment or spread to other parts of the body. The study will evaluate a treatment approach called TPEx, which combines several anti-cancer medications, followed by a maintenance therapy using two drugs: avelumab and cetuximab.

The treatment plan consists of two phases. In the first phase, patients will receive TPEx therapy which includes docetaxel, cisplatin or carboplatin, and cetuximab. After this initial treatment, patients will continue with maintenance therapy using a combination of avelumab and cetuximab. Both medications are given through an infusion into a vein.

The main purpose of this study is to determine how well this combination treatment works in terms of helping patients live longer. The study will also track how the disease responds to treatment and monitor any side effects that patients may experience, particularly during the maintenance phase of treatment with avelumab and cetuximab.

1 Initial treatment phase – TPEx

You will receive a combination treatment called TPEx, which consists of three medications given through an intravenous infusion:

– Docetaxel (Docetaxel Hospira)

– Platinum-based drug (either Cisplatin or Carboplatin, depending on your medical condition)

– Cetuximab (Erbitux)

2 Maintenance phase

After completing the initial TPEx treatment, you will begin a maintenance phase that includes two medications:

– Avelumab (Bavencio) given through intravenous infusion

– Cetuximab (Erbitux) given through intravenous infusion

3 Regular monitoring

Throughout the study, your condition will be monitored through:

– Regular blood tests to check your blood cell counts and organ function

– Imaging scans (CT or MRI) to assess how your disease responds to treatment

– Regular checks of your general health and any side effects

4 Follow-up period

After completing the treatment, you will continue to be monitored for:

– Any changes in your health condition

– Long-term effects of the treatment

The total study duration is expected to continue until October 2028

Who Can Join the Study?

Age between 18 and 75 years (both men and women can participate)
Must have normal calcium levels in blood (medical treatment to maintain proper calcium levels is allowed)
Confirmed diagnosis of recurring or spreading head and neck cancer that cannot be cured with local treatments
Must have a specific protein called PD-L1 present in tumor tissue samples
Must have good physical performance status (ECOG score of 0 or 1, meaning able to perform most daily activities)
Must be able to receive specific cancer treatments including TPEx, docetaxel, cetuximab, and avelumab
Must have documentation of p16 status (a marker related to HPV virus) for throat cancer cases
Must have tumors that can be measured by CT or MRI scans
If previously treated with radiation therapy alone:
- Must wait at least 4 weeks after curative radiation
- Must wait at least 2 weeks after palliative radiation
Must meet specific blood test requirements:
- Adequate white blood cell count
- Adequate neutrophil count (type of white blood cells)
- Adequate platelet count
- Adequate hemoglobin level
- Proper liver function tests
- Normal bilirubin levels
- Adequate kidney function

Who Cannot Join the Study?

Prior treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies (medications that affect immune system response)
Active or untreated brain metastases (cancer that has spread to the brain)
History of other malignancies (other types of cancer) within 5 years before starting the study
Active autoimmune disease requiring systemic treatment (conditions where immune system attacks healthy cells)
Uncontrolled or significant heart disease
Active infection requiring treatment
Known HIV infection (human immunodeficiency virus)
Active hepatitis B or hepatitis C infection (liver infections)
Pregnant or breastfeeding women
Previous organ transplantation
Use of systemic corticosteroids (strong anti-inflammatory medications) or other immunosuppressive medications
Any condition that would interfere with the safety or study evaluations

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Centr Georges Francois Leclerc	Dijon	France
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Institut De Cancerologie De Lorraine	Vandoeuvre Les Nancy	France
Centre de Radiothérapie Guillaume le Conquérant	Le Havre	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
CHU Grenoble Alpes	La Tronche	France
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Universitaire De Nimes	Nimes	France
Institut Sainte Catherine	Avignon	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Hopital Beaujon	Clichy	France
Clinique Victor Hugo	Le Mans	France
Centre Regional Lutte Contre Le Cancer	STRASBOURG, Alsace	France
Centre Hospitalier Saint Nazaire	St Nazaire	France
Ihxeizjc Rnopunlb Dp Cezsmj Dx Mpaxwkzanjp	Montpellier	France
Cktioy Leyf Bvdgrg	Lyon	France
Agfvqoltax Pkztzdog Habmjsar Ds Mzncyxiac	Marseille	France
Cenftz Oebxq Lykkfwd	Lille	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.12.2024

Trial locations

Investigated drugs:

Avelumab is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which cancer cells use to hide from your immune system. This allows your body’s natural defenses to better recognize and attack the cancer.

Cetuximab is a targeted therapy medication that specifically attaches to proteins found on cancer cells called EGFR (epidermal growth factor receptor). By blocking these proteins, it helps stop cancer cells from growing and spreading. It’s commonly used to treat head and neck cancers.

TPEx is a combination therapy regimen used in treating head and neck cancers. It combines different medications to fight cancer cells in multiple ways, making the treatment more effective than using single medications alone.

Investigated diseases:

Squamous cell carcinoma of head and neck

Squamous Cell Carcinoma of the Head and Neck – A type of cancer that begins in the squamous cells that line the moist surfaces inside the head and neck area. This cancer can develop in various places including the mouth, throat, larynx, and sinuses. The disease can spread (metastasize) to nearby lymph nodes and other parts of the body. When described as recurrent, it means the cancer has returned after initial treatment, while metastatic indicates the cancer has spread to distant parts of the body. The condition typically develops gradually and may affect normal functions like speaking, swallowing, and breathing. The disease can occur in multiple locations simultaneously within the head and neck region.

Trial ID:

2023-510559-41-00

Protocol code:

GORTEC 2024-01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of avelumab and cetuximab combination treatment after TPEx chemotherapy for patients with recurrent or metastatic head and neck cancer receiving first-line therapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?