A Phase 2 Study of Novel Combination Therapies in Participants With Previously Untreated Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Regardless of PD-L1 Expression Status
This study is a Phase 2 clinical trial exploring new ways to treat head and neck cancer that has either returned or spread to other parts of the body. Researchers are investigating different combinations of existing and new drugs, including Carboplatin, Paclitaxel, Zimberelimab, and Domvanalimab. The main goal is to find out how effective these new drug combinations are at shrinking tumours (measured by something called Objective Response Rate) and how long people live without their cancer growing (called Progression-Free Survival). They also want to understand the safety of these treatments. Participants would be 18 years or older with this specific type of head and neck cancer.
At a glance
What is this study about?
If you or someone you know has head and neck cancer that has come back or spread, you might be interested in this research study. Scientists are always looking for better treatments, and this particular study is in an important stage called Phase 2. This means they are testing out new combinations of existing and newer medications to see how well they work and if they are safe.
The study is focusing on a type of cancer called squamous cell carcinoma, which starts in the moist linings of the body, like the mouth, throat, or voice box. When this cancer returns or spreads, it can be more challenging to treat, so finding effective new options is really important.
Researchers will be looking at things like whether the new drug combinations shrink the cancer (this is called the objective response rate) and how long people remain free from their cancer growing or spreading further (this is called progression-free survival). They will also closely monitor any side effects to make sure the treatments are as safe as possible. The aim is to find promising new treatments that could help people with this specific type of head and neck cancer.
Key takeaways
- This is a Phase 2 study for head and neck cancer that has returned or spread.
- It tests new combinations of drugs to find better treatments.
- The study measures how well treatments shrink tumours and prevent cancer growth.
- Safety and side effects will be closely monitored.
- Participants must be at least 18 years old and have this specific cancer type.
- Participation involves regular hospital visits for treatments and assessments.
Who may be eligible?
This study is open to adults who are at least 18 years old. Both men and women can join.
To be eligible, you must have head and neck squamous cell carcinoma that has come back after previous treatment or has spread to other parts of your body. This means you haven't received treatment for this specific recurrent or metastatic cancer before.
Each clinical trial has very specific rules about who can and cannot take part. These rules are put in place to ensure the safety of participants and to make sure the study results are clear. Your doctor will be able to check all the detailed criteria to see if this study is suitable 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 head and neck squamous cell carcinoma?
- Has your cancer come back or spread to other parts of your body?
- Have you not received prior treatment for this specific recurrent or metastatic cancer?
What does participation involve?
If you decide to take part in this study, you'll be given one of the new drug combinations. These drugs are given as an infusion, which means they are put directly into your bloodstream, usually through a drip in your arm. You'll have regular appointments over a period of up to 36 months (3 years) to keep a close eye on your health and how the treatment is affecting your cancer.
These appointments will include medical exams, blood tests, and scans (like CT scans) to check if the cancer is shrinking or changing. Researchers will also be asking you about any side effects you might be experiencing. The study team will explain the exact schedule of visits and treatments, and you'll have the chance to ask any questions you have.
Potential risks and benefits
Locations (3)
- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedFrance
Common questions
What kind of cancer is this study for?
This study is for a specific type of cancer called head and neck squamous cell carcinoma that has either come back after treatment or spread to other parts of the body.
What does Phase 2 mean?
Phase 2 means the study is looking to see how well these new drug combinations work and if they are safe, after earlier tests have shown they might be promising.
Will I know which treatment I'm getting?
The study team will explain the different treatment combinations being tested and how the decision is made about which one you receive if you join.
How long does the study last?
You could be involved in the study for up to 36 months (3 years), with regular check-ups and treatments during that time.
What are the main goals of this study?
The main goals are to see if the new treatments shrink the cancer and how long people live without their cancer growing or spreading.
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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