NOCANO: Nivolumab as neoadjuvant immunotherapy for patients with Oral CANcer and identification of response-predictive biomarkers in tumour draining lymph NOdes
This study, called NOCANO, is looking at a new treatment called nivolumab (brand name OPDIVO) for people with a specific type of mouth cancer, called oral squamous cell carcinoma. It's a Phase II study, which means we're checking its effectiveness and safety in a larger group of people. The main goal is to see how much the medicine shrinks the cancer before surgery. We're also trying to find signs in the body that can tell us if the treatment is working well for someone. This could help doctors choose the best treatment for mouth cancer in the future and potentially improve peoples' chances of a successful outcome.
At a glance
What is this study about?
This study is about an important type of mouth cancer called oral squamous cell carcinoma. Doctors are always looking for better ways to treat this cancer, and one promising area is using medicines before surgery. This particular study is testing a medicine called nivolumab, also known as OPDIVO. It's an immunotherapy, which means it works with your body's own immune system to fight cancer cells. The idea is to give this medicine before surgery to see if it can shrink the tumour and make the surgery more successful.
The main things we want to find out are how often the tumour shrinks significantly after taking nivolumab, and if we can completely get rid of the cancer cells in the tumour or nearby lymph nodes. We're also looking at how much the tumour volume changes. To understand this better, we'll check things like scans and tissue samples after the treatment. This will help us learn if nivolumab is effective in reducing the cancer before a person has surgery.
Beyond just seeing if the treatment shrinks the tumour, we're also very interested in understanding why it works for some people and not others. We'll be looking for special signs, called biomarkers, in the lymph nodes near the tumour. These biomarkers could help doctors in the future predict who will benefit most from nivolumab. The study also carefully checks for any side effects, how the treatment affects quality of life, and how long people live without their cancer returning. This information is crucial for improving future treatments for mouth cancer.
Key takeaways
- This study tests nivolumab, an immunotherapy, for mouth cancer.
- The treatment is given before surgery to try and shrink the tumour.
- We are looking for signs in the body that predict who will benefit most.
- The study also carefully checks for side effects and how patients feel.
- Taking part involves regular visits, tests, and follow-up for up to five years.
Who may be eligible?
To join this study, you would need to be an adult, 18 years or older. The study is open to both men and women.
More detailed checks will be done by the study doctors to make sure it's the right study for you. For example, they'll check you have a specific type of mouth cancer that the study is focusing on, and that you are generally well enough to take part and receive the treatment safely. They will also make sure you haven't received certain other treatments recently.
It's important to discuss all your medical history and current health conditions with the study team. They will explain everything clearly and answer any questions you have about whether you can take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Do you have a specific type of mouth cancer (oral squamous cell carcinoma)?
- Are you generally well enough to receive treatment?
- Are you able to attend appointments for treatment and follow-up?
- Have you not had certain other cancer treatments recently?
What does participation involve?
If you join this study, you would receive the study medicine, nivolumab, which is given through a drip (infusion). This treatment would be given before you have surgery for your mouth cancer. During the study, you would have regular visits to the clinic for various checks. These checks would include scans, blood tests, and physical examinations to see how you are responding to the treatment and to monitor your general health.
We would also ask you to complete questionnaires about your quality of life. After your surgery, the study team will continue to follow your health for up to five years, with follow-up appointments at specific times. This helps doctors understand the long-term effects of the treatment. The total duration of active treatment and close monitoring would be for a specific period, followed by longer-term follow-up.
Potential risks and benefits
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Common questions
What is nivolumab?
Nivolumab, also known as OPDIVO, is a type of medicine called immunotherapy. It helps your body's immune system to recognise and fight cancer cells.
What does a 'Phase II' study mean?
A Phase II study means researchers are testing a new treatment in a larger group of people to see if it's effective for a specific condition and to learn more about its safety.
Will I still need surgery if I join this study?
Yes, this study gives nivolumab before surgery. The aim is to shrink the tumour to make the surgery more effective.
What are 'biomarkers'?
Biomarkers are like clues in your body, such as specific proteins or genes. We're looking for these clues to help predict who might respond best to the treatment.
How long will I be followed up after treatment?
After your treatment and surgery, your health will be monitored by the study team for up to five years to understand the long-term results.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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