A Randomized Phase III Trial of Platinum Chemotherapy plus Paclitaxel with Bevacizumab and Atezolizumab versus Platinum Chemotherapy plus Paclitaxel and Bevacizumab in Metastatic (stage IVB), Persistent, or Recurrent Carcinoma of the Cervix (BEATcc )
This research study is looking at new ways to treat advanced cervical cancer that has spread, come back, or won't go away. It's a 'Phase III' trial, meaning it's comparing a new treatment combination with a standard one that's already in use. Patients will either receive standard chemotherapy plus a drug called Avastin, or the same standard chemotherapy and Avastin, but with an additional medicine called Teccentriq. The main goals are to find out if the new combination helps people live longer and if it stops the cancer from growing for a longer time. Doctors will also check for side effects and how the treatments affect a patient's quality of life.
At a glance
What is this study about?
This study is designed for women who have advanced cervical cancer. This means the cancer has spread to other parts of the body (stage IVB), has come back after previous treatment, or is not responding to treatment. The main purpose of this study is to see if adding an extra medicine, called Teccentriq (also known as Atezolizumab), to a standard treatment plan makes a difference.
The standard treatment usually involves chemotherapy drugs combined with another medicine called Avastin (Bevacizumab). In this study, some patients will receive this standard combination. Others will receive the same standard combination, but with Teccentriq added to it. Teccentriq is a type of immunotherapy, which helps your body's own immune system fight the cancer.
By comparing these two groups, doctors hope to find out if adding Teccentriq helps to stop the cancer from growing for longer or helps people live longer. They will also be carefully monitoring patients for any side effects and how they feel during the treatment. This is a "Phase III" trial, which means it's a larger study to confirm if a new treatment is better than the current standard.
Key takeaways
- This study is testing new treatments for advanced cervical cancer.
- It compares standard chemotherapy plus Avastin, with the addition of Teccentriq.
- The main goals are to see if the new combination stops cancer growth for longer and improves survival.
- Patients will be closely monitored for side effects and how they feel.
- This is a 'Phase III' trial, confirming if a new treatment is better than existing ones.
Who may be eligible?
To be part of this study, you must be an adult woman, aged 18 or over. This study is specifically for women who have cervical cancer that has spread to other parts of the body (called metastatic stage IVB), has come back after treatment, or hasn't responded to previous treatments and is still present. It's important that your doctors confirm this specific type of cervical cancer for you to be considered for the study.
There might be other health conditions or previous treatments that could mean you can't join. For example, if you have certain other serious medical issues or have recently taken specific medications, you might not be suitable. The study team will review your full medical history to make sure participation is safe and appropriate 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.
- Are you an adult woman, aged 18 or older?
- Do you have cervical cancer that has spread, come back, or not responded to previous treatments?
- Are you able to attend regular hospital visits for treatments and tests?
- Are you comfortable with the possibility of being randomly assigned to a treatment group?
- Are you willing to have careful monitoring throughout the study?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups, like flipping a coin. You won't get to choose which group you're in. Both groups will receive infusions (medication given straight into your vein) of chemotherapy and Avastin. One group will also receive infusions of Teccentriq. These infusions will happen on a regular schedule, which your study doctor will explain.
You will have frequent visits to the hospital or clinic for these treatments, as well as for various tests. These tests include blood checks, scans (like X-rays or CT scans) to see how the cancer is responding, and questionnaires to understand how you are feeling and how the treatment is affecting your daily life. You'll be closely monitored for any side effects. This study will involve regular follow-up for a significant period to track how well the treatment works and your overall health.
Potential risks and benefits
Locations (6)
- —UnverifiedItaly
- —UnverifiedNorway
- —UnverifiedFrance
- —UnverifiedSweden
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is 'Phase III' in a clinical trial?
Phase III means this is a major trial comparing a new treatment against the best current treatment to see if it's better or safer.
What does 'metastatic' cervical cancer mean?
It means the cervical cancer has spread from where it started to other parts of your body.
What are Teccentriq and Avastin?
They are medicines given through a drip. Teccentriq helps your own body fight the cancer, and Avastin works by slowing the growth of blood vessels that feed the cancer.
Will I know if I'm getting the new combination?
No, you will be randomly assigned to one of the treatment groups, like picking a card, and neither you nor your doctor will usually know which group you are in.
What if I experience side effects?
The study team will monitor you very closely for any side effects, and they will be on hand to manage them and provide support.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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