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Study of neoadjuvant intratumoral ipilimumab combined with systemic nivolumab in patients with locally advanced resectable oral cavity squamous cell carcinoma

Verified siteRegistered drugNo placebo
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What is this trial about?

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

Oral cavity squamous cell carcinoma is a type of mouth cancer that can be removed by surgery but often has spread locally, making treatment more difficult. The study uses a combination of two immune‑based medicines: an injection directly into the tumor of ipilimumab, which works by blocking a protein called CTLA‑4, and a drip given into a vein of nivolumab, which blocks another protein called PD‑1. Both proteins normally keep the immune system from attacking cancer cells, so blocking them helps the body’s defenses recognize and destroy the tumor. Giving the medicines before surgery is called neoadjuvant therapy, and the injection into the tumor is referred to as intratumoral, while the drip is systemic, meaning it circulates throughout the body.

The purpose of the study is to evaluate how well patients can tolerate the treatment and how effective it is at shrinking the tumor before surgery. Participants receive several doses of the two medicines over a short period, then undergo the planned operation to remove the cancer. After surgery, follow‑up visits include imaging scans such as MRI and routine check‑ups to monitor recovery and any side effects.

Researchers will compare the results with data from patients who receive only one of the medicines or other standard combinations, looking at side‑effect profiles and how much the tumor reduces in size. Blood samples and tissue taken before, during, and after treatment are examined to see how the immune system responds, providing information that may help improve future therapies for this disease.

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

    Baseline assessment

    After joining the study, you will undergo initial assessments that may include blood tests, imaging of the oral cavity, and a biopsy of the tumor to confirm the diagnosis of oral cavity squamous cell carcinoma.

  2. Step 2

    Intratumoral ipilimumab administration

    You will receive an injection of ipilimumab directly into the tumor. the dose is 3 mg per injection. the exact schedule will be determined by the study protocol.

  3. Step 3

    Intravenous nivolumab administration

    You will receive an infusion of nivolumab through a vein. the dose is 240 mg per infusion. the infusion will be performed in a clinical setting and the timing will follow the study schedule.

  4. Step 4

    Neoadjuvant treatment period

    The intratumoral ipilimumab and intravenous nivolumab are given together as neoadjuvant therapy, meaning they are administered before surgery. you will continue to receive the prescribed doses until the planned surgery date, as outlined by the study team.

  5. Step 5

    Surgical removal of the tumor

    After completing the neoadjuvant immunotherapy, you will undergo surgery to remove the locally advanced, resectable oral cancer. the surgery is performed according to standard clinical practice.

  6. Step 6

    Post‑surgery follow‑up

    Following surgery, you will have follow‑up visits that may include additional blood draws, imaging studies, and possibly further biopsies to evaluate the response to the treatment and monitor for any side effects.

Who can join the trial?

10 criteria

  • Have a tissue diagnosis that confirms the cancer is oral cavity squamous cell carcinoma and that it is classified as stage T2–T4 (size of the primary tumor), N0–N3b (extent of spread to nearby lymph nodes), and M0 (no spread to distant parts of the body), and be planned for curative treatment that includes surgery. Histologically confirmed means a lab test on a tissue sample shows the cancer.
  • Be willing and able to sign a written informed consent form agreeing to take part in the study.
  • Be at least 18 years old on the day you sign the consent form.
  • Not have taken any medicines that suppress the immune system in the past 6 months.
  • Not have a history of illegal hard‑drug abuse.
  • Agree to give tissue samples from a fresh tumor biopsy before treatment, from an optional biopsy during treatment, and from the tumor removed during surgery. These samples will be used to check the tumor’s PD‑L1 status (a protein that can affect how the immune system sees the cancer) and for other detailed laboratory studies.
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, meaning you are fully active (0) or able to carry out light work (1) without major limitations.
  • Show adequate organ function (such as healthy liver, kidneys, and blood counts) based on laboratory tests performed within two weeks before any study imaging.
  • If you are a man who is sexually active with a woman who could become pregnant, you must use a birth‑control method that is less than 1% likely to fail each year, and continue using it during the study and for 31 weeks after the last study medication dose.
  • If you are a woman who could become pregnant, you must use an appropriate birth‑control method during the study and for 23 weeks after the last study medication dose. Women who are post‑menopausal, have had a hysterectomy, or are otherwise unable to become pregnant do not need contraception, and men who are infertile (azoospermic) also do not need contraception.

Who cannot join the trial?

12 criteria

  • Has cancer that has spread to other parts of the body ( distant metastasis ).
  • Is pregnant, breastfeeding, or plans to become pregnant during the study period (from screening until 23 weeks after the last dose).
  • Has previously received medicines that target the immune system checkpoints such as anti‑PD‑1, anti‑PD‑L1, anti‑PD‑L2, anti‑CTLA‑4, or similar drugs.
  • Has an active infection with hepatitis B or hepatitis C viruses.
  • Is currently in another clinical study or has been in one within the last 4 weeks and has not fully recovered from side effects (still has side effects worse than mild, i.e., greater than Grade 1).
  • Has another active cancer that is getting worse or needs treatment now, except for certain skin cancers (basal cell carcinoma or squamous cell carcinoma) or early‑stage cervical cancer that has already been treated.
  • Had major surgery for any reason and has not fully recovered from surgery complications before starting the trial.
  • Needs strong steroid medicines (more than 10 mg of prednisone each day) or other immune‑suppressing drugs within 14 days before starting the trial. Inhaled, skin‑applied steroids, or replacement steroids are allowed if there is no active autoimmune disease.
  • Has an active autoimmune disease that required strong steroids in the past 3 months, or has a history of severe autoimmune disease.
  • Shows signs of interstitial lung disease or non‑infectious pneumonitis (inflammation of the lungs not caused by infection).
  • Has an active infection that needs treatment with medicines taken by mouth or IV.
  • Has any other condition, treatment, or lab result that could confuse the study results, make it hard to stay in the trial, or be unsafe, as decided by the doctor.
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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

  • Amsterdam UMC

    Responsive

    The NetherlandsAmsterdam, The Netherlands

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Investigated drugs

  • Nivolumab

    is a medication that works by blocking a protein called PD‑1 on immune cells. By doing this, it helps the body’s immune system recognize and attack cancer cells. In this trial, it is given through an IV (intravenous infusion) and is used as a systemic (whole‑body) treatment to see if it can improve the safety and effectiveness of therapy for people with locally advanced oral cancer that can be surgically removed.

  • Ipilimumab

    is a medication that blocks another protein called CTLA‑4, which normally slows down the immune response. By inhibiting CTLA‑4, ipilimumab aims to boost the immune system’s ability to fight the tumor directly. In the study, it is injected straight into the tumor (intratumoral injection) before surgery, and researchers are testing whether this local approach, combined with the systemic drug, can be safe and work well for treating resectable oral cancer.

What is already known about the treatment

  • NIVOLUMAB

    This medication is given by intravenous infusion, meaning it is slowly poured into a vein. It is an approved drug that is widely used and studied for several types of cancer, including lung and kidney cancers. It works by attaching to the PD‑1 protein on immune cells, blocking the signal that tells the immune system to stand down, so the body can better attack tumor cells. Pharmacologically, it is classified as a monoclonal antibody that targets the PD‑1 checkpoint.

  • IPILIMUMAB

    This medication is injected directly into the tumor (intratumoral injection). It is an approved treatment for melanoma and is currently being tested in clinical trials for oral cavity squamous cell carcinoma. It binds to the CTLA‑4 protein on immune cells, preventing the “brake” signal that limits immune activity, thereby helping the immune system to recognize and destroy cancer cells. It belongs to the class of monoclonal antibodies that target the CTLA‑4 checkpoint.

Investigated diseases

Oral cavity squamous cell carcinoma - Oral cavity squamous cell carcinoma is a type of cancer that starts in the flat cells lining the inside of the mouth. It usually appears as a sore, lump, or red patch that does not heal. Over time the abnormal cells can grow larger and may spread to nearby tissues such as the tongue, gums, or floor of the mouth. The tumor can also extend into deeper layers of the mouth and reach the muscles or bone. As it expands, it may involve surrounding structures and lymph nodes in the neck. The disease often progresses slowly at first but can become more extensive if not addressed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-523617-29-01Estimated enrolment24 patientsSponsorAmsterdam UMC Stichting

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