Tolerability and efficacy of treating locally advanced Resectable Oral Cancer with neoadjuvant INtratumoral anti-CTLA4 ImmunoTherapy combined with systemic anti-PD-1 (ROCinIT).
This study is testing a new approach to treating mouth cancer that can be removed with surgery. Standard care usually involves an operation, often followed by radiotherapy or chemotherapy. In this trial, called ROCinIT, doctors want to see if giving immunotherapy before surgery can help shrink the tumour and stop it from returning. Immunotherapy works by helping your body's natural defences recognise and attack cancer cells. Participants receive two medicines: nivolumab, given through a drip into a vein, and ipilimumab, injected directly into the mouth tumour. The main goal is to check whether this combination is safe and effective. Researchers will also study blood samples, tissue samples, and MRI scans before and after treatment to understand how the immune system responds. The findings could help doctors design better, more targeted treatments for people with mouth cancer in the future.
At a glance
What is this study about?
Mouth cancer (also known as oral cavity cancer) is often treated with surgery to remove the tumour. While surgery is an important and effective treatment, doctors are constantly searching for ways to shrink tumours beforehand. Shrinking the cancer first can make operations easier, help protect healthy tissue, and reduce the risk of the cancer coming back.
This trial, called ROCinIT, tests a treatment given before surgery (known as 'neoadjuvant' therapy). It uses immunotherapy medicines, which train the body's own immune system to spot and destroy cancer cells. Two drugs are used: nivolumab, which circulates throughout the body via an intravenous drip, and ipilimumab, which is injected directly into the tumour in the mouth.
Injecting immunotherapy straight into the tumour is a promising technique. Doctors hope this direct approach will create a strong, focused immune reaction where it is needed most, while keeping general side effects as low as possible. During the study, the research team will use MRI scans, blood tests, and small tissue samples to watch how the tumour and immune cells respond.
Overall, the study aims to find out if this treatment is safe, well-tolerated, and helpful in shrinking mouth tumours before an operation. The results may help guide improved care for future NHS patients facing similar diagnoses.
Key takeaways
- Tests a two-drug immunotherapy treatment given before surgery for mouth cancer.
- One medicine is given by a drip, while the other is injected straight into the tumour.
- Aims to activate the immune system to shrink the cancer safely before an operation.
- Open to adults with locally advanced mouth cancer that can be removed with surgery.
- Taking part is voluntary and will not compromise your standard NHS surgical care.
Who may be eligible?
This trial is for adults aged 18 and over who have been diagnosed with a common type of mouth cancer called squamous cell carcinoma. The cancer must be 'locally advanced'—meaning it may have grown into nearby mouth tissues or local lymph nodes—but is still at a stage where a surgeon can safely operate to remove it.
To be considered, you must be fit enough to receive immunotherapy and to undergo the planned operation. People whose cancer has spread further afield to distant parts of the body, or whose tumours cannot be operated on, will not be suitable for this study.
Your cancer specialist will review your overall health, including your blood test results and any other medical conditions you may have (such as autoimmune illnesses), to ensure that taking part is safe for you.
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.
- You are aged 18 or over.
- You have been diagnosed with squamous cell carcinoma of the mouth.
- Your tumour can be safely removed with surgery.
- Your cancer has not spread to distant parts of your body.
- You are generally well enough to have immunotherapy and an operation.
What does participation involve?
If you take part, you will receive immunotherapy treatment in the weeks leading up to your planned surgery. Nivolumab is given as a drip into a vein in your arm, while ipilimumab is given as a gentle injection directly into the mouth tumour. You will have regular hospital appointments for these treatments and for health checks. During the study, doctors will take blood samples, perform MRI scans to check blood flow and tumour size, and collect small tissue samples (biopsies). After finishing the immunotherapy, you will have your planned surgery to remove the tumour. The care team will then continue to follow your recovery with routine clinic visits and monitoring over several months.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is the main purpose of this study?
The study aims to see if giving two immunotherapy drugs before surgery is safe and helps shrink mouth tumours.
How are the medicines given?
Nivolumab is given through a drip into a vein, and ipilimumab is injected directly into the tumour in your mouth.
Will taking part delay my planned surgery?
No. The trial treatment is carefully scheduled to fit into the time before your operation so that your surgery is not unsafely delayed.
What happens if I get unpleasant side effects?
The medical team monitors you closely at every visit. If side effects occur, doctors can treat them quickly or adjust your care plan.
Do I have to pay to take part in this trial?
No. In the UK, clinical trial treatments, hospital visits, and extra tests are provided free of charge through the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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