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Study of nivolumab treatment for patients with nasopharyngeal cancer who did not respond to or worsened after platinum chemotherapy

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What is this trial about?

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

This clinical study focuses on patients with nasopharyngeal cancer, a type of cancer that develops in the nasopharynx - the upper part of the throat behind the nose. The study will evaluate the effectiveness of a medication called Nivolumab, which will be given to patients whose cancer has gotten worse during or after treatment with platinum-based chemotherapy.

The study will test how well Nivolumab works in treating this type of cancer. The medication is given as a solution through an intravenous infusion (directly into a vein). Each patient may receive treatment for up to 6 months, with regular doses of the medication.

During the study, patients will have their condition monitored through various medical examinations, including MRI scans (a type of detailed imaging that uses magnetic fields to create pictures of the inside of the body). The study will track how the cancer responds to the treatment, how long patients live without their disease getting worse, and what side effects may occur from the treatment.

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

    Initial assessment

    Your eligibility for the study will be confirmed based on your medical documentation showing nasopharyngeal cancer that has progressed during or after platinum-based chemotherapy

    A medical evaluation will verify that you are over 18 years old and have an ECOG performance scale score of 0-1 (ability to perform daily activities)

  2. Step 2

    Treatment initiation

    You will receive Nivolumab (OPDIVO) through an intravenous infusion

    The medication is given as a solution containing 10 mg/mL of the active substance

  3. Step 3

    First evaluation period - 12 weeks

    After 12 weeks of treatment, you will undergo an MRI scan to assess how your tumor is responding to the treatment

    The medical team will measure if the tumor has decreased in size by at least 30% (partial response) or disappeared completely (complete response)

  4. Step 4

    6-month assessment

    At 6 months, you will have another MRI scan to check for any disease progression

    Your overall health status will be evaluated

    You will complete a quality of life questionnaire (EORTC QLQ-C30)

  5. Step 5

    Long-term follow-up

    Follow-up visits will continue for up to 18 months

    Your overall survival and health status will be monitored at 12 months and 18 months

    Additional quality of life assessments will be conducted

    Regular safety evaluations will be performed throughout the study period

Who can join the trial?

11 criteria

  • You must be at least 18 years old
  • You must have a confirmed diagnosis of squamous cell carcinoma (a type of cancer that starts in the flat cells that line certain organs) through tissue or cell examination
  • Your cancer must have started in the nasopharynx (the upper part of the throat behind the nose)
  • You must have previously received platinum-based chemotherapy that either:
    • Did not work effectively
    • Your cancer got worse during treatment
    • Your cancer must have:
      • Come back in the original location or lymph nodes, or
      • Spread to other parts of the body during or within 6 months after platinum chemotherapy
      • Your ECOG performance status must be 0-1 (meaning you must be able to care for yourself and be up and about more than 50% of waking hours)
      • You must be willing and able to:
        • Provide written informed consent
        • Attend all follow-up visits
        • Undergo all planned study procedures

Who cannot join the trial?

15 criteria

  • Age below 18 years old
  • Pregnant or breastfeeding women
  • Previous treatment with immunotherapy (medications that help your immune system fight cancer)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Active autoimmune disease requiring systemic treatment (conditions where your immune system attacks your own body)
  • Uncontrolled or severe heart disease
  • Active hepatitis B or C infection (liver infections)
  • Active tuberculosis infection
  • HIV infection or AIDS
  • Other active cancers requiring treatment (except for certain skin cancers)
  • Major surgery within 4 weeks before starting the study
  • Treatment with other experimental drugs within 4 weeks before starting the study
  • Severe allergic reactions to similar medications in the past
  • Conditions that might interfere with study procedures or safety evaluations
  • Unable to give informed consent
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-1, which normally prevents T-cells (immune cells) from attacking cancer cells. By blocking this protein, Nivolumab allows your immune system to better recognize and destroy cancer cells. This medication is given through an intravenous infusion (through a vein).

  • Platinum-based chemotherapy

    refers to traditional cancer treatment medications that contain platinum. These medications work by damaging the DNA of cancer cells, which prevents them from dividing and growing. This is mentioned as a previous treatment that patients would have received before starting Nivolumab.

What is already known about the treatment

Nivolumab - A monoclonal antibody medication administered through intravenous infusion, which belongs to the class of immunotherapy drugs known as PD-1 inhibitors. This medication works by blocking the PD-1 protein on immune cells, thereby enabling the body's immune system to better recognize and attack cancer cells, particularly in cases of nasopharyngeal cancer that has progressed after platinum-based chemotherapy. Nivolumab is currently approved by major regulatory agencies and has shown significant promise in clinical trials for treating various types of cancer, with extensive documentation in medical literature supporting its effectiveness in stimulating anti-tumor immune responses.

Investigated diseases

Nasopharyngeal Cancer - A cancer that develops in the nasopharynx, which is the upper part of the throat behind the nose. The disease begins when healthy cells in the nasopharynx develop changes in their DNA, causing cells to grow uncontrollably and form a tumor. These abnormal cells can invade nearby structures and may spread to lymph nodes in the neck. The cancer can develop gradually, often starting with symptoms like a stuffy nose, sore throat, or problems with hearing. It tends to affect the area where the nasal passages connect with the throat, potentially impacting breathing and swallowing as it progresses.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-517479-19-00Protocol code20-NIO-0003Estimated enrolment32 patientsSponsorNarodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy

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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).