Randomized Phase II Trial Assessing the Inhibitor of Programmed Cell Death Ligand 1 (PD-L1) Immune Checkpoint Atezolizumab in Locally Advanced Cervical Cancer (AtezoLACC)
This research study, called AtezoLACC, is looking into a new treatment for women diagnosed with locally advanced cervical cancer. The treatment is a medicine called Tecentriq (atezolizumab), which works by helping your body's immune system fight cancer. We want to find out if this new medicine can help patients live longer without their cancer growing or spreading. The study will also look at how long people live overall, how many people's cancers shrink or disappear, and if the cancer comes back in the same area or spreads elsewhere. We will also carefully check for any side effects of the treatment. This is a Phase II study, meaning we're further exploring how well the treatment works and its safety.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment option for women with locally advanced cervical cancer. Locally advanced means the cancer has grown into nearby tissues but hasn't yet spread to distant parts of the body. The specific medicine being tested is called Tecentriq, and it works differently from traditional chemotherapy. It's an immunotherapy, which means it helps your own immune system recognize and attack cancer cells more effectively.
The main goal of this study is to see if Tecentriq can help patients live longer without their cancer getting worse. This is an important measure because it tells us how effectively the treatment is keeping the cancer in check. We will also be looking at other important aspects, such as how long patients live overall, whether the cancer shrinks or disappears completely, and if it comes back in the same area or spreads to other parts of the body. Throughout the study, we will also be carefully monitoring for any side effects the treatment might cause. This helps us understand the full picture of the treatment's benefits and risks.
This is a 'Phase II' study, which means it's a key step in developing new treatments. In this phase, we are gathering more information about the medicine's effectiveness and its safety in a larger group of people than in earlier studies. The information we learn from studies like this is vital for improving how we treat cancer in the future and for helping doctors make the best choices for their patients.
Key takeaways
- This study explores a new medicine, Tecentriq, for locally advanced cervical cancer.
- It aims to see if Tecentriq can help patients live longer without their cancer growing.
- Participation involves regular hospital visits for treatment infusions and health checks.
- The study also carefully tracks any side effects of the new treatment.
- You'll be part of an important effort to find better cancer treatments.
- You can withdraw from the study at any time without affecting your care.
Who may be eligible?
To join this study, you must be a woman aged 18 or older who has been diagnosed with locally advanced cervical cancer. The doctors leading the study will need to check your medical history, current health, and specific details about your cancer to make sure the study is a good fit for you.
There will also be some other medical requirements, such as certain blood test results and general health checks, to ensure that it's safe for you to take part in the study and receive the treatment being tested. These checks are in place to protect your safety and to ensure the study gathers useful and accurate information.
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 a woman?
- Are you 18 years old or older?
- Have you been diagnosed with locally advanced cervical cancer?
- Are you able to attend regular hospital appointments for treatment and tests?
- Are you willing to be randomly assigned to receive the study drug or standard treatment?
What does participation involve?
If you decide to take part in this study, you will receive the study medication, Tecentriq, through an infusion (a drip into your vein). This will be given at specific times over a period of many months. You will have regular appointments at the hospital or clinic. During these visits, doctors and nurses will perform various assessments to monitor your health and how the treatment is working. These might include physical examinations, blood tests, and scans to check your cancer.
After you finish the active treatment part of the study, you will continue to have follow-up appointments. These follow-up visits are important so the research team can continue to monitor your health and the long-term effects of the treatment. The total time you would be involved in the study, including treatment and follow-up, could extend over several years.
Potential risks and benefits
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Common questions
What is 'locally advanced' cervical cancer?
This means your cancer has grown into nearby tissues but hasn't yet spread to distant parts of your body.
What is Tecentriq?
Tecentriq is a new type of cancer medicine called immunotherapy. It helps your body's own immune system fight the cancer.
Is this a new medicine not available yet?
Yes, Tecentriq is being tested specifically for locally advanced cervical cancer in this study. It's not a standard treatment for this condition yet.
Will I definitely get the new treatment?
This is a 'randomized' study, meaning you will be randomly assigned to either receive the study treatment or standard care. You won't get to choose.
What kind of tests will I have during the study?
You will have regular examinations, blood tests, and scans (like CT or MRI) to check your health and how your cancer is responding.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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