Study Comparing Ivonescimab Alone or Ivonescimab in Combination With Ligufalimab Versus Pembrolizumab for the Treatment of SCCHN
This research study is for people with squamous cell head and neck cancer that has either returned (recurrent) or spread to other parts of the body (metastatic) and has a specific marker called PD-L1. We're testing if two new drugs, ivonescimab (used alone or with ligufalimab), are better than a standard treatment, pembrolizumab. The main goal is to find out if these new treatments can help patients live longer. Participants will be split into three groups, receiving either ivonescimab, a combination of ivonescimab and ligufalimab, or pembrolizumab. The treatment will continue for up to two years, unless the cancer gets worse, side effects become too strong, or other reasons lead to stopping early.
At a glance
What is this study about?
This study is looking into new ways to treat a type of head and neck cancer called squamous cell carcinoma, which has either come back or spread to other parts of the body. For these situations, doctors are always looking for better treatments to help patients. The study focuses on patients whose cancer has a specific feature called PD-L1 positive, which can sometimes mean certain treatments might work well.
The main aim of this research is to see if two new medications, ivonescimab (used by itself) or ivonescimab combined with another drug called ligufalimab, are more effective than pembrolizumab (a commonly used drug for this type of cancer). We especially want to know if these new treatments can help people live longer. Participants will be sorted into three groups by chance, and each group will receive a different treatment plan. This helps us fairly compare the effects of each medication setup.
The treatments will be given through a drip (intravenously) over a set period, generally every three weeks. You would continue receiving this treatment until the cancer gets worse, you experience side effects that are too difficult to manage, or if your doctors decide treatment needs to stop for another important reason. The longest you would be on treatment for this study is two years.
Key takeaways
- This study evaluates new treatments for advanced head and neck cancer.
- It compares ivonescimab (alone or with ligufalimab) to pembrolizumab.
- The main goal is to see if new treatments can help patients live longer.
- You would receive treatment through a drip every three weeks.
- Participation depends on certain health and cancer characteristics (e.g., PD-L1 positive test).
Who may be eligible?
To join this study, you would generally need to be an adult between 18 and 80 years old with head and neck cancer that has returned or spread. Your cancer must also have a specific marker called PD-L1, which doctors can test for.
It’s important that you are generally well enough to take part in a study like this, meaning your body is coping reasonably well with day-to-day activities. You also can't have had previous treatments for your returned or spread cancer, though some past treatments for earlier cancer may be acceptable if enough time has passed. Your doctors would check your overall health and organ function to make sure it's safe for you to participate.
Finally, for your cancer to be included in the study, it needs to be an official diagnosis of squamous cell head and neck cancer, and doctors need to be able to measure it accurately to see if it's getting better or worse during the study.
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 between 18 and 80 years old?
- Do you have confirmed head and neck cancer that has come back or spread?
- Has your cancer been tested and found to be 'PD-L1 positive'?
- Are you generally well enough for daily activities?
- Have you not had previous drug treatments for your returned or spread cancer?
What does participation involve?
If you join this study, you will be assigned by chance to one of three treatment groups. Two groups will receive ivonescimab (one group gets it alone, the other gets it with ligufalimab), and the third group will receive pembrolizumab. All these medications are given through a drip into your arm (intravenously) every three weeks. Each treatment session lasts between one and two hours.
You will have regular appointments for these treatments and to check your health, blood tests, and how the cancer is responding. These appointments will continue for up to two years, or until your cancer gets worse, you experience side effects that are too difficult to manage, or if your doctor decides treatment should stop for another medical reason. After stopping treatment, you would still have follow-up appointments to monitor your health.
Potential risks and benefits
Locations (1)
- Centre Guillaume Le ConquerantVerified postcodeLe Havre, France· Recruiting
Common questions
What kind of cancer is this study for?
This study is for a type of head and neck cancer called squamous cell carcinoma that has either come back or spread to other parts of the body.
What is PD-L1 positive?
PD-L1 positive refers to a specific marker found on your cancer cells. Doctors test for this because it can help predict how well certain treatments might work.
What are the new drugs being tested?
The new drugs being tested are called ivonescimab and ligufalimab. They are being compared to a standard drug called pembrolizumab (also known as KEYTRUDA®).
How will I receive the treatment?
The treatments for this study are given through a drip into your arm, usually once every three weeks.
How long will the treatment last?
Treatment for this study can last for up to two years, unless it needs to stop earlier due to the cancer getting worse or side effects.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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