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A study of ficerafusp alfa and nivolumab in patients with head and neck cancer who did not respond to platinum-based chemotherapy.

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What is this study about?

This study focuses on individuals with head and neck squamous cell carcinoma, a type of cancer that develops in the tissues of the mouth, throat, or voice box. The research specifically looks at patients whose cancer has become platinum refractory, meaning the disease has continued to grow even after being treated with platinum-based chemotherapy. The study aims to compare the effectiveness of a combination of two drugs against a single drug to see if the combination works better.

The treatment being tested involves the use of ficerafusp alfa (also known as BCA 101) given along with nivolumab. This is being compared to patients receiving only nivolumab. During the study, participants will receive these medications through an intravenous infusion, which is a method where medicine is delivered directly into a vein through a small tube.

Participants will be monitored over time to see how their cancer responds to the treatments. This includes checking if the tumors shrink or disappear and tracking how long the disease stays stable before it potentially starts growing again. The study also tracks how long patients live and any side effects that may occur during the treatment period.

Who Can Join the Study?

  • You must be between 18 and 75 years old on the day you sign the consent form.
  • You must have an ECOG performance status of 0 or 1, which means you are able to carry out daily activities and are generally well.
  • You must have a confirmed diagnosis of squamous cell carcinoma of the head and neck, which is a type of cancer that starts in the flat cells lining the mouth, throat, or voice box.
  • The cancer must be located in the oral cavity (mouth), larynx hypopharynx (part of the throat), or oropharynx (the middle part of the throat).
  • Your cancer must have shown signs of growing or spreading, known as progression, within 6 months after receiving platinum-based treatment (a type of chemotherapy).
  • Progression is defined as a new tumor appearing, an increase in the size of an existing tumor, or a biopsy showing that the cancer is still present after radiation treatment.
  • For patients with cancer in the oropharynx, the tumor must be p16 negative, which means a specific protein used to identify certain types of virus-related cancers is not present.
  • You must have a tumor that can be measured using a CT scan (a detailed X-ray image) or an MRI (a scan that uses magnets to show body structures).

Who Cannot Join the Study?

  • You cannot participate if your cancer started in the nasopharynx (the upper part of your throat behind the nose), the paranasal sinuses, the nasal cavity, the salivary glands, the thyroid, or the parathyroid glands.
  • You cannot participate if your cancer is non-squamous histology, which means the cancer cells do not look like flat, scale-like cells under a microscope.
  • You cannot participate if you have or have had pneumonitis (inflammation of the lung tissue) or interstitial lung disease (a group of disorders that cause scarring or inflammation in the lungs).
  • You cannot participate if you have active central nervous system metastases, which are areas where cancer has spread to the brain or spinal cord, or carcinomatous meningitis (cancer that has spread to the protective membranes covering the brain and spinal cord).
  • You cannot participate if you have a history of spinal cord compression caused by a tumor.
  • You cannot participate if you have a history of uncontrolled seizures (sudden, uncontrolled electrical disturbances in the brain), central nervous system disorders, or psychiatric disabilities that prevent you from giving consent or following the study rules.
  • You cannot participate if you have previously received systemic treatment (medicine that travels through the entire body, such as pills or IV drugs) for cancer that has returned or spread.
  • You cannot participate if you have previously used anti-EGFR antibody, anti-TGF-β therapy, or drugs that target checkpoint pathways, such as anti-PD1 or anti-PD-L1 (medicines that change how the immune system finds cancer).
  • You cannot participate if you have recently taken another investigational drug (a medicine being tested in a study) and have not waited the required time for it to leave your system.
  • You cannot participate if you have been diagnosed with or treated for any other type of cancer within the last 2 years, except for certain low-risk skin, cervical, breast, or prostate cancers.
  • You cannot participate if you have had a ST-elevation myocardial infarction (a serious type of heart attack), unstable angina (chest pain that is severe or changing), ventricular arrhythmia (irregular heartbeat originating in the lower chambers of the heart), or a stroke within the last 6 months.
  • You cannot participate if you have congestive heart failure classified as NYHA Class III or IV (severe symptoms that limit physical activity or occur even at rest).
  • You cannot participate if you have deep vein thrombosis (a blood clot in a deep vein) unless you have been on a stable dose of anticoagulants (blood-thinning medicine) for at least 3 months.
  • You cannot participate if you have had a serious systemic infection (an infection affecting the whole body) caused by bacteria, viruses, or fungi within 4 weeks, or an infection requiring hospitalization or parenteral therapy (medicine given through a needle, such as an IV) within 2 weeks.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
CHU Grenoble Alpes La Tronche France

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire De Nimes Nimes France
Institut Sainte Catherine Avignon France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Centre Hospitalier Universitaire Amiens Picardie Amiens France
Institut de Cancérologie de l’Ouest Saint-Herblain France
Centre Francois Baclesse Caen France
Centre Hospitalier Saint Nazaire St Nazaire France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
15.12.2025

Trial locations

Investigated drugs:

Ficerafusp alfa is a medication given as an injection into a vein. In this study, it is being tested to see if it works well when used together with another treatment to help fight certain types of head and neck cancer.

Nivolumab is a type of medicine given through an infusion into a vein. It is used in this trial to treat cancer by helping the body’s own immune system recognize and attack cancer cells.

Investigated diseases:

Head and neck squamous cell carcinoma – This is a type of cancer that begins in the squamous cells lining the mouth, throat, or other parts of the head and neck. It often starts in areas such as the tonsils, tongue, or larynx. The disease typically progresses as abnormal cells multiply uncontrollably and spread to nearby tissues or lymph nodes. As it advances, the cancer can change the shape of structures in the throat or mouth. This condition can also involve the deeper layers of the skin or mucous membranes in the head and neck region.

Trial ID:
2025-521437-88-00
Protocol code:
GORTEC 2025-01
Trial Phase:
Therapeutic exploratory (Phase II)

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