Active not recruitingPHASE2INTERVENTIONAL

Nivolumab and Ipilimumab Treatment in Prostate Cancer With an Immunogenic Signature

This study is investigating two drugs, nivolumab and ipilimumab, which are a type of immunotherapy. It's for men with prostate cancer that has spread (metastatic) and is no longer responding to hormone therapy (castration-resistant), after at least one previous treatment. The researchers want to see if these drugs can help patients whose cancer shows specific genetic patterns, called an 'immunogenic signature,' which might make the cancer more vulnerable to immunotherapy. The study will look at two different combinations of the drug doses to see which is more effective and tolerable. The main aim is to understand if these drugs can shrink the tumour or stop it from growing further in this specific group of patients.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

380

Start

06 Feb 2018

Estimated completion

01 Jun 2027

Prostate Cancer

What is this study about?

This clinical trial is looking into a new way to treat prostate cancer that has spread to other parts of the body (known as metastatic cancer) and is no longer responding to standard hormone treatments. This type of cancer is called metastatic castrate-resistant prostate cancer. The study is specifically interested in men whose cancer has already been treated with at least one other type of therapy.

The trial is testing two drugs, nivolumab and ipilimumab, which are both types of 'immunotherapy'. Immunotherapy works by boosting your body's own immune system to fight cancer cells. The researchers believe that these drugs might be particularly effective in patients whose prostate cancer has certain genetic characteristics, which they call an 'immunogenic signature'. This signature suggests the cancer might be more open to being attacked by the immune system. Examples of these characteristics include issues with how the cancer cells repair their DNA, or if there are many immune cells already present around the tumour.

The study aims to see how well these drug combinations work in shrinking tumours or controlling the cancer's growth. It will compare two different dosing schedules of nivolumab and ipilimumab to find the most promising approach for these specific patients. This research is important because it could offer new treatment options for men with advanced prostate cancer where other treatments have stopped working.

Key takeaways

Tests new immunotherapy drugs (nivolumab and ipilimumab) for advanced prostate cancer.
Specifically for men whose cancer has certain 'immunogenic signatures'.
Compares two different drug dose combinations.
Requires ongoing hormone therapy for prostate cancer.
Close monitoring of health and side effects throughout.
Participation involves regular hospital visits.

Who may be eligible?

This study is for adult men (aged 18 and over) with prostate cancer that has spread and is no longer responding to hormone therapy, and who have already tried at least one other treatment. Important criteria for joining include that your prostate cancer cells must show specific genetic patterns (an 'immunogenic signature') that suggest they might respond to this type of treatment. If initial checks show your cancer doesn't have this signature, you wouldn't be able to continue in the study.

You also need to be in reasonably good general health, able to perform daily activities without too much difficulty (doctors call this a 'WHO performance status of 0-1'), and have healthy enough blood, liver, and kidney function. Your testosterone levels must remain low through ongoing hormone treatment. Your doctors would confirm all these details.

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 an adult male with prostate cancer that has spread?
Has your prostate cancer stopped responding to hormone therapy?
Have you already had at least one other treatment for your metastatic prostate cancer?
Are you generally well and able to carry out most daily activities?
Are you willing to undergo specific tests to check for an 'immunogenic signature' in your cancer?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive two medications, nivolumab and ipilimumab, through a drip (intravenously). There are two groups in the study, each receiving a slightly different dose combination for the first maximum of four treatments, every three weeks. After these initial treatments, you will have a gap and then continue with nivolumab alone every four weeks for up to one year, or until your cancer gets worse, you experience side effects that are too difficult to manage, or you decide to stop.

Throughout the study, you'll have regular hospital visits for blood tests, check-ups, and to receive your medication. You'll also have scans to monitor your cancer. Doctors will carefully monitor your health and any side effects. Your participation continues for up to one year with treatment, or longer for follow-up, unless your cancer progresses or you need to stop. You must continue your existing hormone therapy for prostate cancer throughout the study.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments that are not yet widely available. While these drugs have shown promise in some cancers, it's important to remember that they might not work for everyone, and there's no guarantee of personal benefit. Like all medications, nivolumab and ipilimumab can cause side effects. These could range from mild to serious, and the study team will discuss all known potential risks with you in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University College London Hospital
Verified postcode
London, United Kingdom

Common questions

What is an 'immunogenic signature'?

It's a set of specific characteristics or genetic patterns in your cancer cells that suggest your immune system might be able to recognise and fight them effectively with immunotherapy.

Are nivolumab and ipilimumab new drugs?

They are established immunotherapy drugs, but this study is looking at their use and effectiveness for this specific type of prostate cancer with a particular genetic signature.

Will I know which dose I'm getting?

Yes, you will be assigned to one of the two treatment groups (cohorts) and will know which dose combination you are receiving.

What if my health changes during the study?

Your health will be closely monitored, and your study doctor will decide if it's safe for you to continue. You can also withdraw at any time.

Do I have to keep taking my current prostate cancer medication?

Yes, you must continue your ongoing hormone therapy to keep your testosterone levels low throughout the study.