A phase II, open-label, multicenter trial to investigate the clinical activity and safety of Cabozantinib in combination with avelumab in patients refractory to standard chemotherapy with advanced neuroendocrine neoplasias G3 (NEN G3)
This clinical trial is for people with advanced G3 neuroendocrine neoplasia, a rare form of cancer, that hasn't responded to standard treatments. It's a Phase II study, meaning researchers are further investigating if two medicines, cabozantinib and avelumab, are safe and effective when used together. The main goal is to see how many people show signs of their cancer being controlled after 16 weeks. Researchers will also check how long the treatment keeps the cancer under control, its impact on quality of life, and any side effects. This study aims to find better ways to treat this challenging cancer.
At a glance
What is this study about?
This clinical trial is designed for people who have a specific type of advanced cancer called G3 neuroendocrine neoplasia. This is a rare form of cancer that often begins in cells lining organs like the gut or lungs. The 'G3' means it's a fast-growing type of cancer, and 'advanced' means it has spread from where it started.
The trial is looking at two medicines, cabozantinib and avelumab, which will be given together. Cabozantinib works by blocking certain signals that help cancer cells grow and spread. Avelumab is an immunotherapy, which helps your body's own immune system find and fight cancer cells. Researchers want to see if combining these two drugs can be a more effective way to treat this cancer, especially for those whose cancer hasn't responded well to usual treatments.
The main aim of this study is to find out how well these medicines can control the cancer after 16 weeks of treatment. This means checking if the cancer shrinks, stops growing, or stays stable. Researchers will also be carefully monitoring for any side effects and looking at how the treatment might affect patients' overall well-being and quality of life. The information gathered will help doctors understand if this combination therapy could become a new treatment option for people with G3 neuroendocrine neoplasia.
Key takeaways
- This study is for advanced G3 neuroendocrine neoplasia that hasn't responded to standard treatments.
- It combines two new medicines, cabozantinib and avelumab, to see if they work better together.
- Researchers will check how well the treatment controls the cancer and its effects on quality of life.
- Participants will have regular check-ups, blood tests, and scans.
- This is a Phase II study, continuing to investigate the safety and effectiveness of the combined treatment.
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 would need to have been diagnosed with advanced G3 neuroendocrine neoplasia. This means your cancer is aggressive and has spread. Importantly, if you have a type of lung cancer called small cell lung cancer (SCLC) or a skin cancer called Merkel cell carcinoma, you unfortunately would not be able to join this particular study.
Because this is a medical study, there will be other health checks and criteria that the study doctors will go through with you to make sure it's safe and suitable for you to take part.
- Are you 18 years old or older?
- Have you been diagnosed with advanced G3 neuroendocrine neoplasia?
- Has your cancer not responded to previous standard chemotherapy treatments?
- Do you NOT have small cell lung cancer or Merkel cell carcinoma?
- Are you able to take tablet medication and receive intravenous infusions?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to join this study, you would receive two different medications: cabozantinib, which are film-coated tablets you swallow, and avelumab, which is given as an infusion (drip) into your vein. The specific dose of cabozantinib (20 mg or 40 mg) would be determined by the study doctors.
Throughout the study, you would have regular visits to the clinic for assessments. These visits would involve check-ups, blood tests, and scans to see how the treatment is affecting your cancer and your general health. Researchers will monitor for any side effects very closely. You would also be asked to fill out questionnaires about your quality of life.
The treatment continues until your doctorssee that the cancer has started to grow again, or if you experience side effects that make it unsafe for you to continue. You are free to stop participating in the study at any time.
Potential risks and benefits
Locations (1)
- —Germany
Common questions
What is G3 neuroendocrine neoplasia?
It's a rare and fast-growing type of cancer that starts in hormone-producing cells, often found in organs like the gut or lungs.
What are cabozantinib and avelumab?
These are two different medicines being tested together. Cabozantinib helps stop cancer cell growth, and avelumab helps your immune system fight the cancer.
What does 'Phase II' mean?
It means this study is further investigating if the treatment is safe and effective, usually after earlier studies have shown promising results.
How long will I be on the treatment?
Treatment continues as long as it's helping control your cancer and you are not experiencing severe side effects. The study will monitor effects over many weeks and months.
Will I know if the treatment is working?
Yes, the study team will perform regular scans and tests, and they will discuss the results with you to show how your cancer is responding.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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