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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 trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Treatment assignment

    You will be assigned to one of two groups to receive different medications.

  2. Step 2

    Receiving combination therapy

    In this group, ficerafusp alfa (1500 mg) will be administered as an intravenous injection, which is a medicine delivered directly into a vein.

    This will be given in combination with nivolumab (240 mg) as an infusion, which is a liquid medication passed into the body through a vein over a period of time.

  3. Step 3

    Receiving single therapy

    In this group, nivolumab (240 mg) will be administered alone as an infusion through a vein.

Who can join the trial?

8 criteria

  • 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 trial?

14 criteria

  • 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.
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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.

What is already known about the treatment

  • Ficerafusp alfa

    This medication is an experimental drug provided as a solution for injection into a vein. It is currently being studied in clinical trials and is not yet widely used in standard medical practice. It is used to treat certain types of advanced cancer, specifically head and neck squamous cell carcinoma, by targeting and attaching to specific proteins on the surface of cancer cells to help the immune system recognize them. This drug belongs to a class of medications known as bispecific antibodies.

  • Nivolumab

    This is an approved medication administered as a solution through an infusion into a vein. It is commonly used to treat various types of advanced cancers, including head and neck cancer, to help the body's immune system fight the disease. The drug works by blocking a specific protein on immune cells that prevents them from attacking cancer cells, essentially "releasing the brakes" on the immune system. It is classified as an immunotherapy, specifically a checkpoint inhibitor.

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521437-88-00Protocol codeGORTEC 2025-01Estimated enrolment121 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).