Phase 2, open-label, multicentre, single-arm study to evaluate the activity of the combination of EGFR inhibitors and c-MET inhibitors in patients with platinum-resistant head and neck squamous cell carcinoma after relapse to immunotherapy.
This clinical trial is designed for adults in the UK who have head and neck cancer. Specifically, it's for those whose cancer has returned after receiving immunotherapy, and their cancer is now resistant to platinum-based chemotherapy. The study is a 'Phase 2' trial, which means researchers are actively exploring how well a new combination of two drugs, cetuximab and tepotinib, works together. They want to see if this drug combination can cause the cancer to shrink or stop growing. This is an open-label study, meaning both patients and doctors will know which treatment is being given. Researchers will be checking regularly to see how the treatment affects the size of the cancer. The aim is to find effective new treatments for this type of head and neck cancer.
At a glance
What is this study about?
This study is looking for new ways to treat head and neck cancer. It focuses on a specific situation: when the cancer has come back after previous treatments, including immunotherapy, and is no longer responding to certain chemotherapy drugs (called platinum-based drugs). This can be a challenging situation, so doctors are always looking for better options for patients.
The study is trying out a combination of two drugs that are already known to work in certain cancers. These drugs are called cetuximab and tepotinib. Cetuximab blocks a protein named EGFR, which can help cancer cells grow. Tepotinib blocks another protein called c-MET, which can also help cancers grow and spread. Researchers think that by blocking both these proteins at the same time, they might be able to create a more powerful effect against the cancer.
This is a 'Phase 2' study. This means it's an important step in testing new treatments. In Phase 2 studies, doctors mainly want to see if a drug or drug combination shows enough promise to help patients. They will be carefully checking to see if the treatment shrinks the cancer or stops it from growing.
Key takeaways
- This study is for adults with a specific type of head and neck cancer.
- It's testing a new combination of two drugs, cetuximab and tepotinib.
- The goal is to see if these drugs can shrink the cancer that has come back.
- Regular hospital visits and tests will be part of taking part.
- You have the right to stop participating at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. The study is open to both men and women.
You need to have a type of cancer called head and neck squamous cell carcinoma. This means the cancer started in areas like your mouth, throat, or voice box. Your cancer also needs to have come back or spread after you've already had immunotherapy, and it must now be resistant to a certain type of chemotherapy called platinum-based drugs.
The research team will carry out several tests to make sure that taking part in the study is the right and safest option for you. They will check your general health and specific details about your cancer to confirm you meet all the requirements.
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?
- Do you have head and neck cancer?
- Has your cancer returned after immunotherapy?
- Is your cancer no longer responding to 'platinum-based' chemotherapy?
- Are you able to attend regular hospital appointments?
What does participation involve?
If you decide to take part in this study, you would receive two study drugs: cetuximab and tepotinib. This is an "open-label" study, meaning both you and your doctors will know which treatments you are receiving. The drugs will be given on a regular schedule, and your treatment will continue as long as it is helping you and you are not experiencing severe side effects.
You would need to attend regular appointments at the hospital. These visits will involve blood tests, physical examinations, and scans (like CT scans or MRI scans) to check how the cancer is responding to the treatment and to monitor your general health. These checks are important for your safety and to see if the treatment is working.
The total length of your participation would depend on how your cancer responds and how you tolerate the treatment. Even after you stop receiving the study drugs, there would likely be a follow-up period where the study team would continue to monitor your health.
Potential risks and benefits
Locations (1)
- —UnverifiedItaly
Common questions
What type of cancer is this study for?
This study is specifically for people with head and neck cancer that has returned after immunotherapy and is resistant to platinum-based chemotherapy.
What drugs are being tested?
The study is testing a combination of two drugs called cetuximab and tepotinib.
What does 'Phase 2' mean?
Phase 2 means this is an early study to see if the new drug combination is safe enough and if it shows enough promise in shrinking the cancer to be studied further.
Will I know if I'm getting the study drugs?
Yes, this is an 'open-label' study, so both you and your doctors will know you are receiving cetuximab and tepotinib.
Can I leave the study at any time?
Yes, you have the right to leave the study at any point, and your decision will not affect your future 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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