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Study on Adding Nivolumab to Cisplatin and Radiotherapy for High-Risk Patients with Head and Neck Squamous Cell Carcinoma

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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 squamous cell carcinoma of the head and neck. This cancer affects areas such as the mouth, throat, and voice box. The study is testing a treatment that combines two medications: nivolumab and cisplatin, along with radiotherapy. Nivolumab is a medication that helps the immune system fight cancer, while cisplatin is a chemotherapy drug that kills cancer cells. The purpose of the study is to see if adding nivolumab to the standard treatment of cisplatin and radiotherapy can improve outcomes for patients.

Participants in the study will receive treatment through an infusion, which means the medication is given directly into the bloodstream through a vein. The study will compare the effects of the combination of nivolumab and cisplatin with radiotherapy to the effects of cisplatin and radiotherapy alone. Some participants will receive a placebo instead of nivolumab to help researchers understand the true effects of the medication. The study will last for several months, and participants will have regular check-ups and imaging tests to monitor their health and the progress of the cancer.

The main goal is to determine if the combination treatment can help patients live longer without the cancer coming back. Researchers will also look at overall survival rates and any side effects that may occur. This study is important because it could lead to better treatment options for people with high-risk squamous cell carcinoma of the head and neck who have already had surgery to remove the cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and recovery from surgery.

    The study focuses on patients with squamous cell carcinoma of the head and neck who have undergone surgery.

  2. Step 2

    Treatment preparation

    Radiotherapy is planned to start within 4 to 9 weeks after surgery. An additional week may be allowed if necessary due to healing or logistical issues.

    The treatment involves a combination of medications and radiotherapy.

  3. Step 3

    Medication administration

    The treatment includes cisplatin and nivolumab, both administered through intravenous infusion.

    Cisplatin is provided as a 1 mg/ml solution for infusion.

    Nivolumab is provided as a 10 mg/ml concentrate for infusion.

  4. Step 4

    Treatment process

    The main objective is to evaluate the effectiveness of adding nivolumab to the standard treatment of cisplatin and radiotherapy.

    The primary goal is to assess disease-free survival, which is the time from the start of the study until any recurrence of cancer or death.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess overall survival and any side effects.

    Secondary objectives include evaluating the incidence of new cancers and the safety of the treatment.

  6. Step 6

    Study duration

    The study is expected to continue until December 2029.

    Participants are monitored throughout the study to ensure safety and effectiveness of the treatment.

Who can join the trial?

13 criteria

  • Must be between 18 and 75 years old.
  • Must have a type of cancer called squamous cell carcinoma in the head and neck area, which has been treated with surgery.
  • Cancer must be classified as stage III or IV, or stage II for a specific type of throat cancer with certain conditions, according to a cancer classification system.
  • Must have had a complete removal of the visible tumor during surgery.
  • Must currently be free of any disease.
  • Must have recovered from surgery enough to start treatment with a combination of chemotherapy and radiotherapy.
  • Radiotherapy should be planned to start 4 to 9 weeks after surgery, with a possible extension of 1 week if needed.
  • Must have a high risk of cancer coming back, based on specific criteria like tumor spread beyond its capsule, nerve invasion, multiple lymph node involvement, or close surgical margins.
  • Must have a suitable tumor sample available for testing certain markers related to the immune system.
  • Must have a Performance Status of 0-1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must provide written consent to participate in the study.
  • Must provide information about alcohol use and smoking history.
  • Cancer must be confirmed through a tissue examination and originate from specific areas like the mouth, throat, or voice box.

Who cannot join the trial?

3 criteria

  • Patients who have not had surgery to remove the **squamous cell carcinoma** in the head and neck area. **Squamous cell carcinoma** is a type of skin cancer that can also occur in the lining of certain organs.
  • Patients who are not within the specified age range for the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the body's immune system attack cancer cells. It is an immunotherapy drug that works by blocking a protein called PD-1, which can prevent the immune system from effectively fighting cancer. In this trial, it is used after surgery in patients with high-risk squamous cell carcinoma of the head and neck to see if it can improve outcomes when combined with other treatments.

  • Cisplatin

    is a chemotherapy drug used in this trial to kill cancer cells. It works by damaging the DNA of the cancer cells, which prevents them from dividing and growing. In this study, cisplatin is used in combination with radiation therapy to enhance the treatment's effectiveness against squamous cell carcinoma of the head and neck.

  • Radiation Therapy (RT)

    is a treatment that uses high-energy rays to target and destroy cancer cells. In this trial, radiation therapy is used alongside cisplatin to treat patients who have had surgery for squamous cell carcinoma of the head and neck. The goal is to eliminate any remaining cancer cells and reduce the risk of the cancer returning.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating resected squamous cell carcinoma of the head and neck. It is an immunotherapy drug that works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells. Nivolumab is classified as a checkpoint inhibitor and is being evaluated for its potential to improve disease-free survival when used in combination with chemotherapy and radiotherapy.

  • Cisplatin

    Cisplatin is administered intravenously and is a well-established chemotherapy drug used in the treatment of various cancers, including squamous cell carcinoma of the head and neck. It works by binding to DNA in cancer cells, causing damage that prevents the cells from dividing and growing. Cisplatin is classified as a platinum-based chemotherapy agent and is often used in combination with other treatments, such as radiotherapy, to enhance its effectiveness.

Investigated diseases

Squamous Cell Carcinoma of the Head and Neck – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a small, localized growth that can gradually expand and invade nearby tissues. Over time, it may spread to lymph nodes in the neck and potentially to other parts of the body. The progression of this cancer can vary, with some cases remaining localized while others become more aggressive. Symptoms often include a persistent sore throat, difficulty swallowing, and changes in voice. Early detection and monitoring are crucial for managing its progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513206-65-00Protocol codeGORTEC 2018-01Estimated enrolment680 patientsSponsorGroupe Oncologie Radiotherapie Tete Cou

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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).