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Study of Nivolumab, Cisplatin, and 5-Fluorouracil for Children and Adults with EBV-Positive Nasopharyngeal Cancer

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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 EBV-positive nasopharyngeal carcinoma, which affects the area behind the nose and above the back of the throat. The study involves a combination of treatments, including Nivolumab, Cisplatin, and 5-Fluorouracil. These medications are used as induction therapy, which means they are given at the beginning of treatment to help shrink the tumor before other treatments, like radiation, are used.

The purpose of the study is to see if this combination of medications can increase the number of patients who have a complete response, meaning no signs of cancer, as seen on imaging tests like MRI and PET-CT. This could potentially allow for a reduction in the amount of radiation therapy needed for children, adolescents, and young adults up to 25 years old with cancer that has not spread beyond the local area.

Participants in the study will receive the medications intravenously, which means they are given through a vein. The study will monitor the complete remission rate, which is the percentage of patients who show no signs of cancer after the treatment. It will also look at other outcomes like event-free survival, overall survival, and the safety and tolerability of the treatment. The study is expected to continue until 2028, with the goal of improving treatment outcomes for patients with this type of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, you will receive detailed information about the study and what to expect. You will be asked to provide written consent to participate.

    If you are under 18, your legal guardians will need to provide consent on your behalf.

  2. Step 2

    Initial assessments

    You will undergo initial assessments, including imaging tests like MRI and PET-CT, to measure the extent of the disease.

    These tests help determine the starting point for your treatment and monitor progress throughout the trial.

  3. Step 3

    Treatment phase

    You will receive a combination of medications: nivolumab, cisplatin, and 5-fluorouracil. These are administered through a vein, a process known as intravenous use.

    The specific dosage and frequency of these medications will be determined by the medical team based on your individual needs and the trial protocol.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, you will have regular follow-up appointments to monitor your response to the treatment.

    These appointments will include repeat imaging tests and other assessments to evaluate the effectiveness of the therapy and any side effects.

  5. Step 5

    Completion of trial

    At the end of the trial, a final assessment will be conducted to determine the overall outcome of the treatment.

    You will receive information about the results and any further steps or treatments that may be recommended.

Who can join the trial?

7 criteria

  • Must have a new diagnosis of nasopharyngeal carcinoma confirmed by a test called a biopsy, which checks for cancer cells.
  • If you are between 3 and 17 years old, the diagnosis must be confirmed according to the current WHO classification.
  • If you are 18 years or older, the diagnosis must be EBV-positive nasopharyngeal carcinoma and classified as WHO stage II or III.
  • If you are 25 years or younger, the cancer must be stage II or higher. If you are older than 25, it must be stage III or IV, according to the AJCC, 8th edition.
  • The cancer must be measurable by an MRI scan, following specific guidelines called RECIST 1.1 criteria.
  • Written informed consent is required from legal guardians if the patient is under 18, and from the patient if they are 18 or older.
  • There must be enough tumor tissue available for a central review, including a test called PD-L1 staining. This requires either 2 full blocks or at least 25 slides from a biopsy or surgical specimen.

Who cannot join the trial?

5 criteria

  • Patients who do not have EBV-positive nasopharyngeal carcinoma cannot participate. This is a specific type of cancer in the nose and throat area.
  • Patients older than 25 years cannot participate.
  • Patients with diseases or conditions that make them unable to undergo magnetic resonance imaging (MRI) or PET-CT scans cannot participate. These are special imaging tests used to see inside the body.
  • Patients who cannot receive induction chemotherapy cannot participate. This is a type of cancer treatment given before the main treatment.
  • Patients who cannot have their radiotherapy dosage reduced from 59.4 Gy to 54 Gy cannot participate. Radiotherapy is a treatment that uses high doses of radiation to kill cancer cells.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to help treat nasopharyngeal carcinoma, a type of cancer that occurs in the upper part of the throat behind the nose.

  • Cisplatin

    is a chemotherapy drug that is used to kill cancer cells. It works by damaging the DNA inside the cancer cells, which stops them from growing and dividing. In this trial, cisplatin is used in combination with other treatments to help shrink the tumor before other therapies are applied.

  • 5-Fluorouracil

    is another chemotherapy medication that is used to treat various types of cancer. It works by interfering with the cancer cells' ability to make DNA and RNA, which are essential for their growth and survival. In this trial, 5-fluorouracil is used alongside other drugs to enhance the overall effectiveness of the treatment against nasopharyngeal carcinoma.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in combination with other drugs for its effectiveness in treating EBV-positive nasopharyngeal carcinoma, a type of cancer. The main therapeutic use of Nivolumab is to help the immune system recognize and attack cancer cells. It works by blocking a protein called PD-1 on immune cells, which can help the body’s immune system to fight cancer more effectively. Nivolumab is classified as an immune checkpoint inhibitor, a type of drug that helps the immune system respond more strongly to cancer.

  • Cisplatin

    Cisplatin is administered intravenously, meaning it is delivered directly into the bloodstream through a vein. It is a well-established chemotherapy drug used in the treatment of various cancers, including EBV-positive nasopharyngeal carcinoma. Cisplatin works by damaging the DNA in cancer cells, which prevents them from dividing and growing. It is classified as a platinum-based chemotherapy agent, which is a group of drugs that contain the metal platinum and are used to treat cancer.

  • 5-Fluorouracil

    5-Fluorouracil is given as an intravenous infusion, which means it is administered directly into the bloodstream through a vein. It is a chemotherapy medication used to treat various types of cancer, including EBV-positive nasopharyngeal carcinoma. The drug works by interfering with the DNA and RNA of cancer cells, which stops them from growing and dividing. 5-Fluorouracil is classified as an antimetabolite, a type of drug that mimics the building blocks of DNA and RNA, disrupting the growth of cancer cells.

Investigated diseases

EBV-positive nasopharyngeal carcinoma – Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma is a type of cancer that occurs in the nasopharynx, the area behind the nose and above the back of the throat. It is associated with the presence of the Epstein-Barr virus in the cancer cells. The disease typically begins with symptoms such as a lump in the neck, nasal congestion, or nosebleeds. As it progresses, it may cause hearing loss, ear infections, or difficulty breathing. The cancer can spread to nearby tissues and lymph nodes. Over time, it may also metastasize to distant parts of the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-500676-59-00Protocol codeNPC-NivoEstimated enrolment57 patientsSponsorGPOH gGmbH

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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).