A trial of NZV930, PDR001 and NIR178 for people with advanced cancer

Cancer type:

All cancer types

Status:

Open

Phase:

Phase 1/2

This trial is for people whose cancer has spread elsewhere in the body or continued to grow despite treatment. This is advanced cancer.

More about this trial

Doctors are always looking for ways to improve treatment for people with advanced cancer Open a glossary item. In this trial, researchers are looking at 3 drugs called:

  • NZV930
  • NIR178
  • PDR001

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 immune system Open a glossary item 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:

  • NIR178
  • PDR001
  • NIR178 and PDR001

The aims of the trial are to: 

  • find the best dose 
  • find the best treatment plan 
  • see which combination of treatment works best 
  • learn more about the side effects 
     

Who can enter

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:

  • have cancer that has grown into nearby tissues and you can’t have surgery or radiotherapy to treat it, or the cancer has spread elsewhere in the body
  • have cancer that has got worse and there isn’t another standard treatment Open a glossary item or any other suitable treatment available
  • have an area of cancer that the doctors can take a tissue sample Open a glossary item(biopsy Open a glossary item) from and you are willing to agree to this  
  • are up and about for more than half the day, you can look after yourself but might not be able to work (performance status of 0, 1 or 2)
  • have satisfactory blood test results
  • are willing to use reliable contraception during the trial and for at least 3 months afterwards if there is any chance you or your partner could become pregnant
  • are at least 18 years old 
  • are willing to stop smoking at least 7 days before having the trial drugs if you are a smoker

Who can’t take part

You cannot join this trial if any of these apply. 

Cancer related
You:

  • have cancer that has spread to your brain or spinal cord Open a glossary item and is causing symptoms. You can take part if the cancer spread to your brain was treated at least 4 weeks ago and isn’t causing symptoms
  • had to stop an immunotherapy drug in the past due to bad side effects 
  • have had another cancer treatment within 2 weeks of the first dose of the trial drugs (6 weeks if you had chemotherapy drugs called nitrosoureas Open a glossary itemor mitomycin C)
  • have had drugs that block a chemical in the body called adenosine in the past
  • have any other cancer that has been successfully treated and there have been no signs of it since apart from basal cell cancer Open a glossary item, squamous cell cancer Open a glossary item or any carcinoma insitu (CIS Open a glossary item) that was successfully removed 

Medical conditions
You:

  • have or have had an autoimmune disease Open a glossary item unless it is vitiligo, type 1 diabetes, hair loss (alopecia), thyroid problems that are controlled by medications or a skin condition called psoriasis that doesn’t need treatment
  • have a condition caused by scarring in the lungs called interstitial lung disease or pneumonitis
  • have a heart problem such as a heart attack or angina in the last 3 months that wasn’t well controlled by medication
  • have high blood pressure that isn’t well controlled
  • have had a stroke or mini stroke and you needed treatment 
  • have an infection that needs treatment 
  • have side effects from past treatments that aren’t getting better
  • have had major surgery within 2 weeks of the first dose of trial treatment 
  • have a problem with your gut that might affect how you absorb medication
  • are taking long term steroids of more than 10mg a day or any other treatment that damps down the immune system within 7 days of starting treatment in this trial, apart from inhalers, cream or steroids to replace hormones in the body
  • have had radiotherapy within 2 weeks of trial treatment unless it was radiotherapy to control symptoms
  • are having food, drink or medication that affects the levels of CYP enzymes in the body 
  • have HIV
  • have an active hepatitis B or hepatitis C infection 
  • have TB (tuberculosis)
  • have any other medical condition or mental health problem that the trial team think would affect you taking part in this trial

Other
You:

  • are allergic to any of the drugs in the trial or anything they contain
  • have had a live vaccination Open a glossary item within 4 weeks of starting treatment
  • are pregnant or breastfeeding

Trial design

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)
  • dose expansion (part 2)

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:

  • PDR001
  • NIR178

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: 

  • NZV930 and NIR178
  • NZV930 and PDR001
  • NZV930, NIR178 and PDR001

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:

  • week
  • 2 weeks
  • 4 weeks

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):

  • when you join the trial
  • at the end of the trial

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:

  • see what happens to the trial drugs in the body
  • see how the drug works in the body 
  • look for biomarkers Open a glossary item

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.

Hospital visits

You see the doctor and have some tests before taking part. These tests include:

  • a physical examination
  • blood tests
  • heart trace (ECG Open a glossary item)
  • CT scan or MRI scan

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:

  • 1 month
  • 3 months 
  • 5 months 

Side effects

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:

  • hardening of blood vessels in people with low levels of adenosine in the blood. The trial team check for this.
  • a possible reaction to the infusion causing symptoms such as fever, chills, feeling or being sick, headache, dizziness, shortness of breath, low blood pressure, skin rash or itching and weakness

The most common side effects of PDR001 are:

The most common side effects of NIR178 are:

  • feeling or being sick
  • heartburn
  • skin rash
  • tiredness 

The trial team will tell you about all the side effects of treatment before you join the trial.

Location

London

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Udai Banerji

Supported by

Novartis

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16142

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Around 1 in 5 people take part in clinical trials

3 phases of trials

Around 1 in 5 people diagnosed with cancer in the UK take part in a clinical trial.

Last reviewed:

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