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Study on Immunotherapy with Nivolumab and Ipilimumab for Patients with Recurrent Head and Neck Cancer After Surgery

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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 head and neck squamous cell carcinoma (HNSCC), which can return after initial treatment. The study is looking at how well two medications, nivolumab and ipilimumab, work when given after surgery to remove the cancer. Nivolumab is also known by the code name BMS936558, and ipilimumab is known as BMS-734016 or MDX-010. These medications are given through a drip into a vein, a method known as intravenous infusion.

The purpose of the study is to see if these medications can help prevent the cancer from coming back after surgery. The study will have two groups of patients. One group will receive nivolumab alone, and the other group will receive a combination of nivolumab and ipilimumab. The study will last for about two years, during which time the patients will be monitored to see if the cancer returns and to check for any side effects from the medications.

Participants in the study will receive treatment for up to six months, and their health will be checked regularly. The study aims to find out if these treatments can help patients live longer without the cancer coming back. This research is important because it could lead to better treatment options for people with high-risk recurrent head and neck 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, including age, health status, and previous treatments.

    A written informed consent form is signed, indicating understanding and agreement to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status. This includes laboratory tests and imaging to confirm the absence of distant metastases.

    Women of childbearing potential undergo a pregnancy test, and all participants are advised on contraception requirements during and after the study.

  3. Step 3

    Treatment initiation

    Treatment begins within 8 weeks after salvage surgery. The treatment involves the administration of nivolumab alone or in combination with ipilimumab.

    Both medications are administered as a solution for infusion through intravenous use.

  4. Step 4

    Treatment schedule

    The specific dosage and frequency of nivolumab and ipilimumab are determined by the study protocol. The treatment duration is aligned with the study's objective to evaluate two years of disease-free survival.

  5. Step 5

    Monitoring and follow-up

    Regular monitoring is conducted to assess the effectiveness of the treatment and to identify any side effects. This includes routine check-ups and additional laboratory tests.

    Participants are monitored for two years to evaluate disease-free survival and overall health outcomes.

  6. Step 6

    Completion of study

    Upon completion of the study period, a final assessment is conducted to evaluate the overall health status and any long-term effects of the treatment.

    Participants receive information on the study's findings and any further recommendations for their health care.

Who can join the trial?

25 criteria

  • The patient must have had **salvage surgery** for high-risk recurrent head and neck squamous cell carcinoma (HNSCC). Salvage surgery is a procedure done to remove cancer that has come back after initial treatment.
  • The patient must have an **ECOG** performance status of 0 or 1. This is a scale used to assess how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must not be taking **immunosuppressive** medications, like steroids, in doses higher than 10 mg/day of prednisone or equivalent, for at least 2 weeks before starting the study treatment. Immunosuppressive medications are drugs that reduce the strength of the body's immune system.
  • The patient must have certain laboratory test results within specific ranges, such as:
    • **White blood cells (WBC)** greater than 2000/μL
    • **Polynuclear neutrophils** greater than 1.5 x 109/L
    • **Platelets** greater than 75 x 109/L
    • **Hemoglobin** greater than 8.0 g/dL
    • **ALAT/ASAT** less than 3 times the upper limit of normal (ULN). These are liver enzymes.
    • **Bilirubin** less than 1.5 times the ULN, except for Gilbert Syndrome where it should be less than 3.0 mg/dL. Bilirubin is a substance made during the normal breakdown of red blood cells.
    • **Creatinine clearance** greater than 40 mL/min or serum creatinine less than 2.0 times the ULN. This measures kidney function.
    • Women of childbearing potential must have a negative pregnancy test within 24 hours before starting the study treatment and agree to use effective contraception or abstain from sex during the study and for at least 5 months after the last treatment. Men must agree to use condoms during the study and for at least 7 months after the last treatment.
    • Women who are breastfeeding must stop nursing before the first dose of the study drug and until 5 months after the last dose.
    • The patient must understand and sign a written informed consent form before any study-specific procedures are done. They must also be willing to attend study visits and follow procedures.
    • The patient must be part of a social security system or have similar benefits.
    • The patient must not have severe side effects (grade III or IV) from previous radiation treatment, except for salivary gland issues.
    • The patient must have a recurrence or a second primary tumor of HNSCC in an area that was previously treated with radiation at a dose of 50 Gys or more.
    • The patient must have HNSCC in specific areas like the oral cavity, oropharynx, hypopharynx, or larynx if it has spread beyond the larynx, or isolated nodal recurrence.
    • The patient must have had salvage surgery with the intent to cure and complete removal of visible cancer. The timing between previous radiation and salvage surgery varies depending on the study group.
    • The patient must have a recurrence that is considered high risk and needs additional treatment, such as:
      • Clinically infiltrative recurrence or a second primary tumor
      • Nodal recurrence 3 cm or larger, or a combination of local and nodal recurrence
      • Superficial recurrence with high-risk features seen in the surgical specimen
      • Nodal recurrence smaller than 3 cm but with capsular rupture
      • The patient must not have cancer that has spread to distant parts of the body, confirmed by a CT scan.
      • The patient must have healed enough to start additional treatment within 8 weeks (plus or minus 2 weeks) after salvage surgery.
      • The patient must be between 18 and 75 years old.

Who cannot join the trial?

8 criteria

  • Patients who have not undergone salvage surgery for high-risk recurrent head and neck squamous cell carcinoma. Salvage surgery is a type of surgery done to remove cancer that has come back after initial treatment.
  • Patients who are not considered high risk for recurrence of head and neck squamous cell carcinoma. High risk means there is a greater chance that the cancer will come back.
  • Patients who are unable to receive adjuvant therapy after surgery. Adjuvant therapy is additional treatment given after the main treatment to lower the risk of the cancer returning.
  • Patients who are not eligible for treatment with nivolumab or the nivolumab-ipilimumab combination. These are specific medications used to help the immune system fight cancer.
  • Patients who are not within the specified age range for the study. The study includes certain age groups only.
  • Patients who are not part of the specified clinical trial groups. The study is designed for specific groups of patients.
  • Patients who are not male or female, as the study includes both genders.
  • Patients who are part of a vulnerable population that is not selected for this study. Vulnerable population refers to groups of people who may need special protection or consideration in research.
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Investigated drugs

  • Nivolumab

    is a type of immunotherapy used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. In this study, it is given to patients after they have undergone surgery to remove head and neck cancer, with the goal of preventing the cancer from coming back.

  • Ipilimumab

    is another immunotherapy drug used in combination with nivolumab in this trial. It also helps the immune system fight cancer by targeting a different part of the immune response. When used together with nivolumab, it aims to enhance the overall effectiveness of the treatment in preventing the recurrence of head and neck cancer after surgery.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently used in medicine as an immunotherapy treatment for various cancers, including head and neck squamous cell carcinoma. The main therapeutic indication for nivolumab in this trial is as an adjuvant therapy after salvage surgery for high-risk recurrent head and neck cancer. At the molecular level, nivolumab works by blocking the PD-1 receptor on T-cells, enhancing the immune system's ability to attack cancer cells. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also administered intravenously and is used in combination with nivolumab in this trial. It is recognized in medical literature as an immunotherapy agent for treating certain types of cancer. The primary therapeutic indication here is to serve as part of a combination therapy with nivolumab for patients with high-risk recurrent head and neck cancer after surgery. Ipilimumab functions by targeting the CTLA-4 receptor on T-cells, which helps to boost the immune response against cancer cells. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

Investigated diseases

Head and Neck Squamous Cell Carcinoma (HNSCC) – This is a type of cancer that arises from the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It often begins as a small, localized growth or sore that does not heal. As the disease progresses, it can invade nearby tissues and spread to lymph nodes in the neck. Advanced stages may involve further spread to distant parts of the body. The progression of the disease can vary, with some cases remaining localized while others become more aggressive. Factors such as tobacco use, alcohol consumption, and human papillomavirus (HPV) infection can influence its development and progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-516810-39-00Protocol codeCSET N°2017/2536Estimated enrolment140 patientsSponsorInstitut Gustave Roussy

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