A Phase 2, Randomised, Double-Blind, Placebo-Controlled, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Tolerability, and Effects on Tumour Biomarkers of the NOX1/4 Inhibitor Setanaxib, when Administered with the PD-1 Inhibitor Pembrolizumab, in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
This study, called a Phase 2 trial, is testing a new treatment combination for head and neck cancer that has either returned or spread to other parts of the body. The combination involves a new drug called Setanaxib and an established cancer medicine called Pembrolizumab (also known as KEYTRUDA). The main goal is to find out how well this combination shrinks tumours, if it's safe to use, and if it helps improve the disease. Some patients will receive the active drugs, while others will be given a dummy pill (placebo) instead of Setanaxib to help researchers compare the results fairly. The study also investigates how these medicines affect certain markers within the tumour, which could provide more clues about how they work.
At a glance
What is this study about?
This study is a ‘Phase 2’ clinical trial, which means it's one of the earlier steps in testing new medicines for people. It's specifically for those with a type of head and neck cancer called Squamous Cell Carcinoma that has either come back after treatment or has spread to other parts of the body. The trial aims to see if combining a new drug called Setanaxib with an existing cancer treatment called Pembrolizumab (also known as KEYTRUDA) can be more effective than Pembrolizumab alone.
The main thing the researchers want to find out is how much the tumours shrink when people take both medicines together, compared to those who take Pembrolizumab with a dummy pill. They will measure the tumours using scans. They also want to understand if the combination is safe and if people can tolerate the side effects. This research is important because it could lead to new ways to treat this type of head and neck cancer, potentially offering more options for patients.
The study is also looking at how these medicines affect certain chemicals and cells within the tumour itself. This can help scientists understand how the drugs work at a biological level and why they might be effective. By understanding these effects, future treatments might be even more targeted and successful.
Key takeaways
- This study explores a new drug combination for head and neck cancer.
- It aims to see if Setanaxib plus Pembrolizumab shrinks tumours more effectively.
- The study also checks for safety and how patients tolerate the treatment.
- Some patients will receive a placebo for the new drug (Setanaxib) to help compare results.
- Participation involves regular hospital visits, including scans and blood tests.
Who may be eligible?
To join this study, you must be at least 18 years old. Both men and women can take part.
Because this study is very specific, there will be other important health requirements that your cancer doctor will need to check. For example, they will need to review your exact type of head and neck cancer, your general health, and any other treatments you might be having. It's important that you discuss your full medical history with them to see if this study is suitable for you.
The best way to find out if you might be eligible is to talk to your specialist doctor or nurse. They can explain all the specific criteria and help you understand if this research study is a good option 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?
- Do you have Squamous Cell Carcinoma of the head and neck that has returned or spread?
- Are you able to attend regular hospital appointments for tests and check-ups?
- Have you discussed your exact cancer type and previous treatments with your doctor?
What does participation involve?
If you decide to take part in this study, you'll be assigned to one of two groups by chance, like flipping a coin. You won't know which group you're in, and neither will your doctors. One group will receive the new drug Setanaxib along with Pembrolizumab (KEYTRUDA). The other group will receive a dummy pill (placebo) instead of Setanaxib, but will still get Pembrolizumab (KEYTRUDA).
You will have regular hospital visits for scans, blood tests, and check-ups to monitor your health, tumor size, and any side effects. You'll take the study medication as prescribed, and the team will closely follow your progress. The total duration of your participation in the study will depend on your individual response to treatment, but there will be a follow-up period to understand the long-term effects.
Potential risks and benefits
Locations (4)
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedFrance
- —UnverifiedPoland
Common questions
What is Pembrolizumab (KEYTRUDA)?
Pembrolizumab is an existing cancer medicine that works by helping your own immune system fight cancer cells.
What is a 'dummy pill' or placebo?
A dummy pill (placebo) looks exactly like the study drug but contains no active medicine. It helps researchers fairly compare the effects of the active drug.
How will my tumour be measured?
Your tumour will be measured using regular scans to see if it shrinks or changes over time.
Will I know which treatment group I'm in?
No, this is a 'blinded' study, meaning neither you nor your doctors will know if you are receiving Setanaxib or the dummy pill.
What happens if the treatment isn't working for me?
Your medical team will closely monitor your condition, and if the treatment isn't working or if you experience significant side effects, they will discuss alternative options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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