A phase II study of ficerafusp alfa (BCA 101) in combination with nivolumab in platinum refractory head and neck squamous cell carcinoma patients who progressed within 6 months after multimodal treatment for locally advanced disease ( BICARA)
This research study, called BICARA, is looking into a new treatment for head and neck squamous cell carcinoma, a type of cancer that starts in the moist linings of the head and neck. The study is for patients whose cancer hasn't responded well to earlier treatments, specifically those who had multimodal treatment for advanced disease and whose cancer worsened within six months. Doctors are combining two medications, Ficerafusp Alfa and Nivolumab (also known as OPDIVO), to see if they can work better together. The main goal is to find out how many patients experience their cancer shrinking or disappearing. They will also look at how long this improvement lasts, how long patients live without their cancer getting worse, and any side effects the treatment might cause.
At a glance
What is this study about?
This study is called BICARA and it's trying out a new way to treat a specific type of cancer. It focuses on head and neck squamous cell carcinoma, which is a cancer that can affect areas like the mouth, throat, or voice box. This trial is for people whose cancer has been particularly difficult to treat, specifically those who had strong treatments for advanced cancer in the past and whose cancer started to grow again within six months.
The researchers are combining two different medicines, Ficerafusp Alfa and Nivolumab (you might know Nivolumab as OPDIVO). They want to see if using these two drugs together can help shrink the cancer or even make it disappear in some patients. This is a 'Phase II' study, which means it builds on earlier research that showed these drugs might be helpful. The main thing they want to measure is how many patients see their cancer get smaller or go away completely.
They will also be carefully watching other important things. This includes how long the cancer stays shrunk or gone, how long patients live without their cancer getting worse, and how long patients live in general. Safety is very important too, so they will be keeping a close eye on any side effects patients might experience during the treatment.
Key takeaways
- Tests a new combination treatment for specific head and neck cancer.
- Aims to shrink tumours in patients whose cancer progressed quickly.
- Involves regular hospital visits for treatments and checks.
- Potential for new treatment option, but also possible side effects.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. Both men and women can take part. The study is specifically for patients with head and neck squamous cell carcinoma.
It's important that your cancer has previously been treated with multiple approaches for locally advanced disease, but that it has started to grow or come back within six months of those treatments ending. This study is for a specific group where previous treatments haven't kept the cancer in check for very long.
There will also be other health checks and tests to make sure the treatment is safe for you and that you meet all the medical requirements for the study. Your doctor will be able to tell you exactly if your medical history fits the study's specific criteria.
- Are you at least 18 years old?
- Do you have head and neck squamous cell carcinoma?
- Did your cancer return or grow within 6 months after earlier treatments for advanced disease?
- Are you able to attend regular hospital visits for treatment and tests?
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 new combination treatment, Ficerafusp Alfa and OPDIVO, usually given through a drip into your arm (an infusion). The precise schedule of these treatments, including how often and for how long, will be explained by the study team.
Throughout the study, you will have regular visits to the hospital or clinic. These visits will involve blood tests, physical examinations, and scans (like CT scans) to check how the cancer is responding and to monitor for any side effects. These assessments are vital to make sure the treatment is safe and effective for you.
After you finish the main treatment period, there will be a follow-up phase where doctors will continue to check on your health and the status of your cancer at regular intervals. The total duration of your involvement could vary, but the team will discuss the expected timeline with you before you agree to participate.
Potential risks and benefits
Locations (1)
- —France
Common questions
What kind of cancer is this study for?
This study is for a type of cancer called head and neck squamous cell carcinoma, which affects areas like the mouth or throat.
What are the two medicines in this treatment?
The study is testing a combination of two medicines: Ficerafusp Alfa and Nivolumab (also known as OPDIVO).
What does a 'Phase II' study mean?
A Phase II study means researchers are testing if the treatment works and is safe in a larger group of patients, after initial studies showed it might be helpful.
What will doctors be looking for in this study?
They mainly want to see how many patients have their cancer shrink or disappear, and also how long that effect lasts and if there are any side effects.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any point, and it won't affect your ongoing medical care.
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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