A Phase II, Randomized, Double-Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients with Recurrent/Metastatic PD-L1-Positive Squamous Cell Carcinoma of the Head and Neck
This research study is for people with a specific type of head and neck cancer called squamous cell carcinoma, which has come back or spread to other parts of the body. We are looking at two different treatment combinations. One combination includes two drugs, atezolizumab and tiragolumab. The other combination includes atezolizumab and a placebo (a dummy drug). The main goal is to find out if these combinations can help shrink the cancer and how long the effect lasts. We also want to understand if these treatments can help people live longer, how they affect daily physical activities, and what side effects they might cause. This is a Phase II study, meaning we are exploring how well these new drug combinations work.
At a glance
What is this study about?
This study is investigating new treatment options for a type of cancer that starts in the flat cells lining the head and neck. This is often called squamous cell carcinoma of the head and neck, or SCCHN. Specifically, the study is for people whose cancer has either returned after previous treatment or has spread to other parts of the body.
The study aims to compare two different treatment plans. Both plans include a drug called atezolizumab. One plan also includes another drug called tiragolumab, while the other plan includes a placebo, which looks like tiragolumab but has no active medicine. The purpose is to understand if adding tiragolumab to atezolizumab is more effective at shrinking tumors and helping people live longer compared to atezolizumab alone. We will also be carefully monitoring any side effects that might occur with these treatments.
This is a 'Phase II' study, which means it's an important step in exploring if these new drug combinations are safe and show promise in treating this type of cancer. The results from this study will help us decide if further, larger studies are needed. We hope this research will lead to better treatment options for people living with squamous cell carcinoma of the head and neck.
Key takeaways
- Targets recurrent or spreading head and neck squamous cell carcinoma.
- Compares two drug combinations for effectiveness and safety.
- Atezolizumab is included in both treatment groups.
- Seeks to improve tumor shrinkage and survival time.
- Monitors side effects and quality of life.
- It's a Phase II study, exploring new treatment potential.
Who may be eligible?
This study is looking for adults aged 18 or older who have been diagnosed with squamous cell carcinoma in the head and neck area. This means the cancer has come back after treatment or has spread to other parts of the body.
Doctors will need to confirm certain factors about your cancer before you can join, such as specific markers on your cancer cells. There might also be other medical conditions or treatments that could prevent you from taking part, to ensure the study is safe for you.
Both men and women are welcome to participate. The medical team will carefully review your health and medical history to ensure this study is a good fit 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 18 years old or older?
- Have you been diagnosed with squamous cell carcinoma of the head and neck?
- Has your cancer come back or spread to other parts of your body?
- Are you able to visit the hospital regularly for treatments and check-ups?
What does participation involve?
If you decide to take part in this study, you would receive either atezolizumab plus tiragolumab or atezolizumab plus a placebo, given through an infusion (a drip into your arm). The study is designed to be 'double-blind,' meaning neither you nor your doctor will know which combination you are receiving.
Throughout the study, you would have regular hospital visits for examinations, blood tests, and scans to monitor your health and how the treatment is working. We would be tracking various things like how your physical activity changes, how long the treatment helps control the cancer, and any side effects you experience.
Your participation would involve a series of treatment cycles, followed by regular check-ups. The total duration of your involvement would depend on how the treatment works for you, but there would be follow-up appointments even after treatment ends to see how you are doing.
Potential risks and benefits
Locations (6)
- —UnverifiedGreece
- —UnverifiedFrance
- —UnverifiedPoland
- —UnverifiedCzechia
- —UnverifiedSpain
- —UnverifiedHungary
Common questions
What type of cancer is this study for?
This study is for squamous cell carcinoma of the head and neck that has returned or spread.
What are the main treatments being tested?
We are testing two combinations: atezolizumab plus tiragolumab, and atezolizumab plus a placebo (a dummy drug).
What does 'double-blind' mean?
It means neither you nor your doctor will know which treatment combination you are receiving.
How long will I be in the study?
The length of your participation depends on how the treatment works for you, with follow-up after treatment ends.
Can I leave the study if I change my mind?
Yes, you can withdraw from the study at any time, and it won't affect your 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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