
“I think it’s really important that people keep signing up to these type of trials to push research forward.”
Please note - this trial is no longer recruiting patients. We hope to add results when they are available.
This trial is for people whose cancer has spread elsewhere in the body or continued to grow despite treatment. This is advanced cancer.
Doctors are always looking for ways to improve treatment for people with . In this trial, researchers are looking at 3 drugs called:
NZV930 is a new drug. We know from early research that it blocks a chemical in the body called adenosine. Adenosine helps tumours to grow and spread and stops the from attacking cancer cells. Blocking adenosine can help the immune system to fight cancer.
NIR178 is another drug. It works in a similar way to NZV930.
PDR001 is an immunotherapy drug. It helps the body's immune system to find and kill cancer cells.
In this trial everyone has NZV930 and some people will also have:
The aims of the trial are to:
The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply.
You:
Who can’t take part
You cannot join this trial if any of these apply.
Cancer related
You:
Medical conditions
You:
Other
You:
This is a phase 1 trial. 344 people will take part in this trial worldwide including 20 people from the UK.
This trial is in 2 parts:
Dose escalation (part 1)
In this part of the trial, researchers want to find the best dose and schedule of treatment. The first few people to take part will have a low dose of NZV930. If they don’t have any bad side effects, the next few will have a higher dose. And so on until they find the highest safe dose. This is a dose escalation study.
After this they want to find the best dose of NZV930 to give with:
They do this the same way as above. The drugs you have depend on when you join the trial. The trial team can tell you more about this.
Dose expansion (part 2)
In this part of the trial researchers test the best dose and best schedules they found in part 1 in more people. This part of the trial is randomised. You are put into treatment groups by computer. Neither you nor your doctor can choose which group you are in.
You have 1 of the following:
How you have the drugs
You have NVZ930 as a drip into a vein. This takes about 1 to 2 hours each time. You might have it every:
This depends on when you join the trial.
You have PDR001 as a drip into a vein once every 4 weeks. This takes between 30 minutes and 2 hours each time. You have this every 4 weeks.
NIR178 is a capsule. You take this twice a day. The trial team recommend you avoid food, drink or medication that contains caffeine. For example try not to drink more than 2 cups of coffee a day.
Please note, you cannot smoke (tobacco or marijuana) if you are having NIR178. If you are a smoker, you need to stop at least 7 days before you can start having treatment. Your doctor can prescribe nicotine patches or nicotine chewing gum to help you quit smoking.
Samples for research
The researchers will ask for samples of tissue (biopsy):
They plan to use them to find out more about how immunotherapy treatment works.
You have some extra blood tests as part of this study. These are to:
They also ask for a sample for genetic research. You don’t have to give this sample if you don’t want to. You can still take part in the main trial.
You see the doctor and have some tests before taking part. These tests include:
During treatment you see the doctor regularly and have the same tests. How often you have them depends on which treatment you are having. The trial team can tell you more.
You have a CT or MRI scan every 8 weeks for the first 40 weeks. And then every 3 months until you stop treatment.
When you stop treatment, the trial team will follow you up at:
The trial team monitor you during treatment and afterwards. Contact your advice line or tell your doctor or nurse if any side effects are bad or not getting better.
PDR001, NZV930 and NIR178 can affect the immune system. They may cause inflammation in different parts of the body which can cause serious side effects. They could happen during treatment or some months after treatment has finished. Rarely these side effects could be life threatening.
If you have any of these side effects, you should tell the doctor or nurse as soon as possible. You should tell them that you are having or have had an immunotherapy.
This is the first time people are having NZV930. So we don’t know about all the side effects. The side effects we know about so far include:
The most common side effects of PDR001 are:
The most common side effects of NIR178 are:
The trial team will tell you about all the side effects of treatment before you join the trial.
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Professor Udai Banerji
Novartis
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
“I think it’s really important that people keep signing up to these type of trials to push research forward.”