Durvalumab (MEDI4736 ) plus tremelimumab in resectable, locally advanced squamous cell carcinoma of the oral cavity: a window of opportunity study
This research study is investigating two new medicines given together before surgery for people with a type of mouth cancer called squamous cell carcinoma, which has spread locally but can still be removed. The main goal is to see if these drugs can increase the number of certain immune cells (called CD8 cells) within the cancer. This would suggest the drugs are helping the body fight the cancer. We'll also be looking at how well patients do over time, if the treatment is safe, and using special scans to understand the cancer better. This is an early phase study, meaning we're still learning a lot about these treatments in this specific situation. It’s for adults aged 18 and over, both men and women.
At a glance
What is this study about?
This study is designed for people who have a specific type of mouth cancer called squamous cell carcinoma. This cancer is considered "locally advanced," meaning it has grown into nearby tissues but hasn't spread to distant parts of the body, and doctors believe it can still be entirely removed by surgery. The exciting part about this study is that it's testing a new approach: giving certain medications before surgery. This is sometimes called a "window of opportunity" because it offers a chance to see how the drugs affect the cancer directly before it's removed.
The main aim of this research is to see if two particular drugs, called Durvalumab (also known as IMFINZI) and Tremelimumab (also known as IMJUDO), can get the body's own immune system to work harder against the cancer. Specifically, researchers will look for an increase in special immune cells, called CD8 cells, inside the tumour. If these cells increase, it suggests the treatment is waking up the immune system to fight the cancer. These drugs are a type of immunotherapy, which means they help your immune system recognise and attack cancer cells.
Alongside checking the immune response, the study will also carefully monitor how safe these new drug combinations are and how patients feel while taking them. They'll also use advanced scanning techniques to get a detailed picture of the cancer. The hope is that by understanding how these drugs work and if they can boost the immune system before surgery, we can potentially find better ways to treat this type of mouth cancer in the future.
Key takeaways
- This study explores new immune-boosting drugs for mouth cancer before surgery.
- It aims to see if the drugs can activate your body's immune system against the cancer.
- It's an early-stage study for locally advanced mouth cancer that can be operated on.
- Participants will receive study drugs, undergo scans, and have follow-up appointments.
- Your health will be closely monitored throughout your participation.
Who may be eligible?
This study is looking for adults who are 18 years old or older, and it's open to both men and women.
To be considered, you need to have been diagnosed with a type of mouth cancer called squamous cell carcinoma. This cancer must be "locally advanced," meaning it has grown into nearby tissues but doctors believe it can be completely removed with surgery.
There might be other health requirements or conditions that would mean you couldn't join the study, but the healthcare team running the study would discuss all of these with you in detail.
- Are you 18 years old or older?
- Do you have squamous cell carcinoma of the mouth?
- Has your doctor told you the cancer is 'locally advanced' but can still be removed by surgery?
- Are you able to attend regular hospital appointments and scans?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study medications (IMJUDO and IMFINZI) as infusions, which means they would be given directly into your vein, and potentially Cisplatin, also by infusion. These treatments would be given for a short period before your planned surgery to remove the cancer.
Throughout the study, you would have regular appointments at the hospital or clinic. These visits would involve check-ups with the doctor, blood tests, and scans (like special PET/MR scans) to see how you are responding to the treatment and to monitor your general health. After your surgery, the study team would continue to follow up with you to see how you are doing in the long term. The total duration of your involvement, including follow-up, would be fully explained by the study team.
Potential risks and benefits
Locations (1)
- —Belgium
Common questions
What kind of cancer is this study for?
This study is for a specific type of mouth cancer called squamous cell carcinoma, which has spread locally but can still be removed by surgery.
What are Durvalumab and Tremelimumab?
These are types of immunotherapy drugs that aim to help your body's immune system fight the cancer.
Will I still have surgery if I join this study?
Yes, the plan is for you to receive the study drugs before having your surgery as planned.
What does 'CD8 infiltration' mean?
It means the study is checking if more specific immune cells, called CD8 cells, are getting into the cancer. This suggests the treatment is helping your immune system fight it.
How long will I be involved in the study?
The study involves treatment before surgery, and then regular check-ups afterwards. The study team will explain the full timetable to you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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