Phase 2 INSPIRE trial: Ipilimumab with Nivolumab in molecular-selected patients with castration-resistant prostate cancer
This research study, called INSPIRE, is looking into how effective a combination of two drugs, YERVOY and OPDIVO, is for men with a specific type of prostate cancer. This is for cancer that has spread (advanced) and is no longer being controlled by standard hormone treatments, often called 'castration-resistant' prostate cancer. The main goal is to see if these medicines can keep the cancer from growing or shrinking it for at least six months. We're also carefully checking for any side effects and how well patients respond to the treatment overall. This information will help us understand if this combination could be a useful new treatment option.
At a glance
What is this study about?
This study is called the INSPIRE trial, and it's looking at men with prostate cancer that has become more advanced. Specifically, it's for prostate cancer that has continued to grow or spread even though patients are receiving hormone treatment. This is often called 'castration-resistant prostate cancer' because it means the cancer cells are no longer fully controlled by reducing male hormones.
The main idea behind this study is to test a combination of two medicines, YERVOY and OPDIVO. These drugs are a type of treatment called immunotherapy. Immunotherapy works by boosting your body's own immune system to help it fight cancer cells. Researchers want to see if using these two drugs together is better at controlling the cancer than using one alone, and whether it’s a safe option for suitable patients.
The most important thing researchers want to find out is how many patients have their cancer either shrink or stop growing for at least six months. This is called the 'disease control rate'. They will also be carefully monitoring for any side effects and studying how the body responds to these treatments in different ways to understand if this combined approach could be a valuable new treatment in the future.
Key takeaways
- This study is for men with advanced prostate cancer not responding to hormone therapy.
- It tests two immunotherapy drugs, YERVOY and OPDIVO, given together.
- The main goal is to see if the drugs can control the cancer for at least 6 months.
- Researchers will also carefully monitor any side effects.
- Participation involves regular hospital visits for infusions and health checks.
Who may be eligible?
To join this study, you would need to be a male adult, at least 18 years old. There's no upper age limit, as long as you meet all the other health requirements.
You must have advanced prostate cancer that is no longer responding to standard hormone treatment. This means the cancer has continued to grow despite these treatments. The researchers are looking for patients who have specific characteristics in their cancer cells, which will be identified through special tests.
There will also be other health checks and requirements to make sure that taking part in the study would be safe for you. These might include blood tests and general health assessments to confirm you are well enough to receive these specific medications.
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 a man, 18 years old or older?
- Do you have prostate cancer that has spread or grown?
- Is your prostate cancer no longer responding to standard hormone treatments?
- Are you willing to have special tests to check your cancer's characteristics?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you decide to join this study, you would receive the study drugs, YERVOY and OPDIVO, through an infusion (a drip into your arm). This would happen at regular intervals over a period of time, usually at the hospital. The exact schedule will be explained to you by the study team.
You would have regular appointments at the hospital or clinic. These appointments would involve blood tests, physical examinations, and scans (like CT or MRI scans) to check how well the treatment is working and to monitor for any side effects. You might also be asked to complete questionnaires about how you are feeling.
The length of your participation would depend on how your cancer responds to the treatment and whether you have any side effects. The study team will explain the full schedule of visits, drug administration, and follow-up during the consent process.
Potential risks and benefits
Locations (1)
- —UnverifiedNetherlands
Common questions
What is 'castration-resistant prostate cancer'?
This is prostate cancer that has continued to grow or spread, even when hormone therapies are being used to lower testosterone levels.
What are YERVOY and OPDIVO?
These are medicines that fall into a category called immunotherapy. They work by helping your body's own immune system find and fight cancer cells.
What is a 'Phase 2' trial?
A Phase 2 trial means researchers are continuing to test a new treatment that has shown some promise in earlier studies. They want to find out more about how well it works and its safety.
Will I definitely get the new drugs if I join?
Yes, in this specific trial, all participants will receive the combination of YERVOY and OPDIVO. There isn't a placebo group in this study.
What does 'disease control rate' mean for me?
It means the study will measure how many patients have their cancer either shrink or stop growing for at least six months while on the treatment.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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