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Study of Nivolumab for Patients with Oral Cancer to Reduce Tumor Size Before Surgery

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

This clinical trial is focused on studying Oral Squamous Cell Carcinoma (OSCC), a type of cancer that affects the mouth. The treatment being tested is called Nivolumab, also known by its code names BMS936558 and ABP 206. Nivolumab is a medication that is given as an infusion, which means it is delivered directly into the bloodstream through a vein. The purpose of the study is to see how effective Nivolumab is in reducing the size of the primary tumor before surgery.

Participants in the study will receive two doses of Nivolumab before their planned surgery. The study will monitor how the tumor responds to the treatment and whether it becomes smaller. Researchers will also look at the lymph nodes, which are small glands that help fight infection, to see if they can predict how well the treatment is working. The study will also track any side effects that participants may experience from the treatment.

The trial will continue to follow participants for up to five years to observe their overall health and survival rates. This long-term follow-up will help researchers understand the full impact of Nivolumab on the disease and its potential benefits for patients with Oral Squamous Cell Carcinoma. The study aims to provide valuable information that could improve treatment options for this type of cancer in the future.

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 trial

    Upon joining the trial, the participant provides written and dated consent to confirm their willingness to participate.

    Eligibility is confirmed, ensuring the participant is at least 18 years old, has not received prior immunotherapy, and has a confirmed diagnosis of oral squamous cell carcinoma (OSCC).

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the participant's health status. This includes checking the Eastern Cooperative Oncology Group (ECOG) performance status, which should be 0 or 1, indicating full activity or some symptoms but nearly fully ambulatory.

  3. Step 3

    Treatment administration

    The participant receives the medication nivolumab, which is administered as a solution for infusion. This involves receiving the medication through a vein over a period of time.

    The treatment consists of two doses of nivolumab given before surgery. The exact schedule and dosage are determined by the medical team.

  4. Step 4

    Monitoring and evaluation

    Throughout the treatment period, the participant's response to the medication is closely monitored. This includes measuring the size of the primary tumor and checking for any changes.

    Regular assessments are conducted to track any side effects or adverse events related to the treatment.

  5. Step 5

    Surgery preparation

    After completing the treatment with nivolumab, the participant is prepared for surgery. The goal is to reduce the tumor size before the surgical procedure.

    The medical team evaluates the participant's readiness for surgery and any potential changes in the surgical plan based on the treatment response.

  6. Step 6

    Post-treatment follow-up

    Following surgery, the participant undergoes regular follow-up visits to monitor recovery and assess long-term outcomes.

    The follow-up period may extend up to five years, during which the participant's overall health, survival rate, and any recurrence of the disease are evaluated.

Who can join the trial?

7 criteria

  • The person is willing to participate and has given their written and dated consent to join the trial.
  • The person has not received any immunotherapy before. (Immunotherapy is a type of treatment that helps your immune system fight cancer.)
  • The person is 18 years or older at the time of signing the consent form.
  • The person has a primary diagnosis of oral squamous cell carcinoma (OSCC), confirmed by a doctor through tests.
  • The cancer is classified as Stage T2-4 N0-3 M0 according to the UICC TNM classification. (This is a system used to describe the size and spread of cancer.)
  • The person is planned to have surgery aimed at curing the cancer as the main treatment.
  • The person has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. (This is a scale used to assess how a disease affects a patient's daily living abilities. 0 means fully active, and 1 means restricted in physically strenuous activity but able to carry out light work.)

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides Oral Squamous Cell Carcinoma (OSCC) cannot participate.
  • Patients who have received any other cancer treatment within the last 30 days are not eligible.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with uncontrolled medical conditions, such as high blood pressure or diabetes, cannot join the study.
  • Pregnant or breastfeeding women are not allowed to participate.
  • Patients with active infections, such as HIV or hepatitis, are excluded.
  • Patients who have had a major surgery within the last 4 weeks are not eligible.
  • Patients with a history of autoimmune diseases, where the immune system attacks the body, cannot participate.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of drug or alcohol abuse within the last 6 months are excluded.
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Investigated drugs

Nivolumab is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this clinical trial, nivolumab is given before surgery to see if it can help shrink the size of oral cancer tumors, making them easier to remove. The goal is to see if this treatment can improve the outcomes of surgery by reducing the tumor size beforehand.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an injection into a vein, typically given in a hospital or clinic setting. It is currently being studied in clinical trials for its effectiveness in treating oral squamous cell carcinoma (OSCC), a type of cancer affecting the mouth. The main use of nivolumab is to help the body's immune system fight cancer by blocking a specific protein that prevents immune cells from attacking cancer cells. This medication is classified as an immunotherapy drug, which means it works by boosting the body's natural defenses to combat cancer.

Investigated diseases

Oral squamous cell carcinoma (OSCC) – This is a type of cancer that occurs in the tissues of the mouth, often starting in the flat, thin cells lining the lips and inside of the mouth. It typically begins as a small, painless sore or lump that does not heal. As it progresses, the tumor can grow larger and may invade deeper layers of tissue, potentially affecting nearby structures such as the jawbone or lymph nodes. Over time, it can cause symptoms like difficulty swallowing, changes in speech, or persistent mouth pain. The disease may spread to other parts of the body, including the lymph nodes in the neck. Early detection and monitoring are crucial for managing its progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521006-18-00Protocol codeNOCANOEstimated enrolment60 patientsSponsorKarolinska University Hospital

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