A trial of a vaccine called CV9104 for prostate cancer that has spread and is not responding to hormone therapy

Please note - this trial is no longer recruiting patients. We hope to add results when they are available.

Cancer type:

Prostate cancer

Status:

Closed

Phase:

Phase 1/2

This trial is looking at a vaccine called CV9104 for prostate cancer that has spread and is no longer responding to hormone therapy, but isn’t causing symptoms.

The immune system can recognise and kill cancer cells. But it is not always very good at doing this. In this trial, researchers are looking at a vaccine called CV9104 that can help the immune system to recognise and attack prostate cancer cells.

If prostate cancer has spread outside the prostate gland, doctors often treat it with hormone therapy. This can work very well, but at some stage the cancer may start to grow again. This may not cause symptoms, but your doctor might see changes on a scan or there may be an increase in the level of PSA in your blood.

The men taking part in this trial have prostate cancer that scans or blood tests show is getting worse. But their cancer is not causing symptoms or only causing very mild symptoms. The researchers will compare the CV9104 vaccine with a dummy drug to see if it helps men in this situation.
The aims of the trial are to

See if CV9104 slows down the growth of prostate cancer and helps men to live longer
Learn more about the side effects

Who can enter

You may be able to enter this trial if you

Have prostate cancer that has spread outside your prostate gland and is getting worse despite having at least 2 types of hormone therapy
Have a low level of the hormone testosterone in your blood (the trial team will test this)
Are unlikely to need any other type of cancer treatment in the next 3 months
Are well enough to carry out all your normal activities, apart from heavy physical work (performance status of 0 or 1)
Have satisfactory blood test results
Are at least 18 years old
Are willing to use reliable contraception if you are sexually active and there is any chance your partner could become pregnant

You cannot enter this trial if you

Have cancer that has spread to your brain or spinal cord, or to body organs such as your liver or lungs (you can take part if the cancer has spread to your bones)
Have already had chemotherapy for prostate cancer that has spread
Have already had immunotherapy for prostate cancer, another experimental cancer vaccine or a drug called ipilimumab
Have had abiraterone or an experimental hormone therapy drug
Have had any other experimental cancer treatment in the last 4 weeks
Take denosumab or a bisphosphonate drug, unless you started taking it at least 4 weeks ago and are going to carry on taking it throughout the trial
Have had severe pain caused by your cancer in the last 4 weeks
Have recently had major surgery or have an operation planned
Have a broken bone (a fracture) or your cancer is pressing on your spinal cord (spinal cord compression
Need to take steroids or other drugs that damp down your immune system
Have skin problems such as eczema or psoriasis affecting your upper arms or thighs
Have had your spleen removed or have had a bone marrow transplant
Have an autoimmune disease such as rheumatoid arthritis or other problems with your immune system – the trial team can advise you about this
Have problems passing urine (urinary retention) that can’t be controlled with medication
Have high blood pressure that can’t be controlled with medication or certain other heart problems – the trial team can advise you about this
Have ever had fits (seizures), swelling in your brain (encephalitis) or multiple sclerosis
Have an infection that needs treatment
Are HIV, hepatitis B or hepatitis C positive
Have problems with addiction to drugs or alcohol
Are allergic to anything in the injections
Have had any other type of cancer in the last 5 years, apart from basal cell skin cancer
Have any other medical condition that the trial team think would make it unsafe for you to take part

Trial design

This trial will recruit about 200 men. It is a randomised trial. The men taking part are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. And neither of you will know which group you are in. This is called a double blind trial.

Out of every 3 men joining the trial, 2 have the CV9104 vaccine and 1 has a dummy drug (placebo Open a glossary item ).

Trial Diagram

You have CV9104 (or the dummy drug) as injections into the skin on the inside of your upper arm and thigh. There are 12 separate injections each time you have treatment.

You have treatment 10 times over a period of nearly 6 months. But if the injections are helping, you may be able to carry on having it for longer than 6 months.

If your cancer gets worse during the first 6 months, you can start having another type of treatment such as chemotherapy as well as having the injections.

The trial team will ask you to fill out a questionnaire before you start treatment, a number of times during treatment and after you finish treatment. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the trial team and have some tests before you start treatment. The tests include

Physical examination
Heart trace (ECG )
Blood tests and urine tests

You may also have a bone scan, CT scan or MRI scan.

In the week before you have the first injections, you have an ultrasound scan of your kidneys.

You go to hospital at least 11 times during the first 6 months. If the treatment is helping and you carry on having the injections for longer, you then have them every 6 weeks for up to a year and every 3 months after that.

You have regular blood tests throughout your treatment. You have a bone scan and a CT or MRI scan every 3 months for up to a year and then every 6 months after that.

When you finish treatment, you see the trial team again within the next 4 weeks. After that, they will contact you by phone every 3 months to find out how you are and whether you are having any other treatment.

Side effects

As CV9104 Is a new drug, there may be side effects we don’t know about yet. In trials of a very similar drug, the most common side effects have been

A skin reaction such as redness at the injection site
Tiredness, high temperature (fever) and chills
Inability to pass urine (urinary retention)
Diarrhoea
Constipation
Loss of appetite

It is possible that the vaccine could cause an allergic reaction with skin redness, rash, itching, difficulty breathing or dizziness. The trial team will monitor you closely and treat any symptoms quickly.

The trial team will talk to you about all the possible risks before you agree to take part in the trial.