A study of PDR001 in combination with other drugs for advanced cancer

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

Cancer type:

Bowel (colorectal) cancer
Breast cancer
Kidney cancer
Lung cancer
Non small cell lung cancer
Secondary cancers

Status:

Closed

Phase:

Phase 1

This study is combining PDR001 with other drugs for cancer that has spread to the nearby tissue (locally advanced) or to another part of the body (metastatic). 

This study is for people with:

More about this trial

When cancer spreads it becomes more difficult to treat. Researchers are looking for ways to improve treatment for people with advanced cancer. 

In this study they are looking at adding targeted drugs to PDR001. 

PDR001 is an immunotherapy drug. It works by helping the immune system Open a glossary item fight cancer. 

The researchers are combining PDR001 with:

  • panobinostat 
  • everolimus
  • LCL161
  • HDM201
  • QBM076

These are all targeted cancer drugs Open a glossary item

The study team have enough people in the panobinostat, everolimus, QBM076 and LCL161 groups. They are looking for people to join the HDM201 group. 

HDM201 works by helping a gene Open a glossary item called TP53 work. TP53 can stop cancer cells growing and might even kill them. 

The aims of this study are to find:

  • the best dose of panobinostat, everolimus, LCL161, HDM201 and QBM076 to give with PDR001
  • what happens to these drugs in the body
  • out about the side effects
     

Who can enter

The following bullet points list the entry conditions for this study. Talk to your doctor or the study 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 study if you have one of the following:

  • bowel cancer that doesn’t have a change in the genes that help repair damage and, or doesn’t have a change in the TP53 gene
  • triple negative breast cancer    
  • kidney cancer that doesn’t have a change in the TP53 gene    
  • non small cell lung cancer that is an adenocarcinoma Open a glossary item 

For those who have bowel cancer or kidney cancer, the study team will test a piece of your cancer tissue for the TP53 gene. 

All of the following applies to everyone. You:

  • have cancer that has spread to the nearby tissue or to another part of the body
  • have had standard treatment Open a glossary item for your cancer and it has continued to get worse or you aren’t able to have standard treatment or there is no standard treatment for your cancer   
  • have an area of cancer that can be measured
  • have an area of cancer that the study team can take a tissue sample (biopsy Open a glossary item) from and you are willing to have tissue samples taken as part of the study
  • have satisfactory blood test results
  • are able to do everything apart from heavy physical work (performance status 0 or 1)
  • are willing to use reliable contraception during treatment and for up to 6 months after if you or your partner could become pregnant. Women using a hormonal contraception in the QBM076 or HDM201 group must be willing and able to change to another type of contraception.
  • are at least 18 years old

Who can’t take part

You cannot join this study if any of these apply. 

Cancer related
You:

  • have symptoms of cancer spread to the brain or spinal cord or you need treatment such as radiotherapy or surgery for the cancer spread or you are having an increasing dose of steroids within 2 weeks of starting treatment 
  • have had another cancer apart from cancers that were successfully treated and there hasn’t been any sign of it for the past 2 years, such as successfully treated non melanoma cancers Open a glossary item and carcinomas in situ Open a glossary item
  • have had an anti cancer treatment that reaches the whole body (systemic treatment) within 2 weeks of the start of treatment, for mitomycin C and nitrosoureas Open a glossary itemit is within 6 weeks and for immunotherapies Open a glossary itemit is within 4 weeks. You might not be able to take part if you have had panobinostat or a similar drug before.
  • have radiotherapy within 2 weeks of starting treatment apart from radiotherapy to a small area to relieve symptoms such as pain
  • still have moderate to severe side effects form previous treatment apart from hair loss, hearing loss and nerve damage affecting the hands and feet 

Medical conditions
You cannot join the study if any of the following apply. You:

  • have had a very severe reaction to targeted drugs called monoclonal antibodies Open a glossary item
  • are allergic to the drugs, or their ingredients, used in the treatment groups. If you are allergic to a particular drug you might be able to join a treatment group that doesn’t have that drug.
  • have scarring of the lung tissue (interstitial lung disease) or moderate to severe inflammation of the lungs (pneumonitis) caused by medication
  • have heart problems such as a heart attack or angina in the past 3 months, congestive heart disease or irregular heart beats
  • have an autoimmune disease Open a glossary item apart from vitiligo, type 1 diabetes, hypothyroidism Open a glossary item caused by an autoimmune disease that needs hormone replacement treatment, psoriasis not needing treatment that reaches the whole body or any other previous autoimmune disease that is not likely to come back
  • have HIV, active hepatitis C or active hepatitis B
  • have problems with the digestive system Open a glossary item that will affect how well tablets and capsules are absorbed by the body
  • have an active infection that needs antibiotics
  • are taking steroids apart from as replacement for adrenal gland Open a glossary item problems, creams, inhalers, nose spray and eye drops
  • are taking any other drugs that affect how your immune system works
  • have major surgery within 2 weeks of starting treatment
  • have had a growth factor Open a glossary item to increase your red blood cells within 3 weeks of starting treatment
  • have any other medical or mental health condition that your doctor or the study team think could affect you taking part
  • have an experimental drug as part of another clinical trial within 2 weeks of starting treatment
  • are taking medication that affects the CYP enzymes unless you are able to stop them or have a different medication 

Other
You cannot join this study if any of the following apply. You:

  • have a live vaccination Open a glossary item within 4 weeks of starting treatment or need a live vaccination during treatment
  • are pregnant or breastfeeding
     

Trial design

This is an international phase 1 study. The team need about 400 people worldwide to join with 35 people from the UK. 

There were 5 treatment groups. 4 treatment groups are now closed they are: 

  • PRD001 with LCL161 
  • PDR001 with everolimus
  • PDR001 with panobinostat 
  • PDR001 with QBM076

The group open for people to join is PDR001 with HMD201.

The dose of PDR001 is the same in all groups. 

PDR001 with HMD201 group
The first few people in each group will have a low dose of HMD201 with PDR001. If they don’t have any bad side effects the next few people will have a higher dose of HMD201 until they find the best dose to give with PDR001. 

Dose expansion study
In this part of the study more people have HMD201 with PDR001. The team want to find out more about how well these combinations work and possible side effects. 

You have PDR001 as a drip into a vein. It can take between 30 minutes and 2 hours. You have it once every 4 weeks. Each 4 week period is called a cycle of treatment. 

HDM201 is a capsule. You take it on day 1 and day 8 of each 4 week treatment cycle. You take it on an empty stomach, that is an hour before eating or 2 hours after eating. Your doctor will tell you how many capsules you need to take. 

You can have up to 6 cycles of treatment as long as it is helping you and the side effects aren’t too bad. This takes about 6 months. 

After 6 cycles of treatment if your cancer starts to grow again you might be able to have further treatment. Your doctor will talk to you about this if it happens. 

Blood and tissue samples 
The team will take a small piece of cancer tissue (biopsy Open a glossary item):

  • when you agree to join the study
  • between your 2nd and 3rd cycle of treatment
  • if your cancer starts to grow again 

They take blood samples before starting treatment and during treatment. 

They use these blood and tissues samples to find out:

  • what happens to these drugs in your body
  • more about the cancer you have
  • how these drugs affect your immune system
  • how cancers avoid immunotherapy 
     

Hospital visits

You see the doctor to have some tests when you agree to take part. These tests include:

  • physical examination
  • blood tests
  • urine tests
  • a sample of cancer tissue (biopsy)
  • heart trace (ECG Open a glossary item)
  • heart scan (ECHO Open a glossary item or MUGA Open a glossary item)
  • CT scan or MRI scan

You see the doctor regularly during treatment for blood samples and to see how you are.

You have a CT scan or MRI scan:

  • at week 12 (before starting treatment cycle 3)
  • and then every 6 weeks.

At the end of all your treatment you see the doctor for the same tests you had at the start.

After treatment a member of the study team will phone you at:

  • a month
  • 2 months
  • 5 months  

They will ask about how you are and if you have started any other anti cancer treatment.

Side effects

Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:

  • you have severe side effects 
  • your side effects aren’t getting any better
  • your side effects are getting worse

Your doctor will give you a card (the same size as a credit card) that you should always carry. On the card are phone numbers of people to contact in case of an emergency. 

PDR001 is a new drug and there may be side effects we don’t know about yet. The common side effects reported so far include:

This treatment affects the immune system. This 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. In some people, these side effects could be life threatening. Contact the advice line or the trial team if you have any of these side effects.

HMD201 is a new drug and there might be side effects we don’t know about yet. The common side effects reported so far include:

  • feeling or being sick
  • diarrhoea or constipation
  • loss of appetite
  • tiredness
  • taste changes
  • feeling weak
  • stomach (abdominal) pain
  • a drop in blood cells causing tiredness, an increased risk of infection, bleeding and bruising 
  • a change to the way the liver, kidneys and pancreas works
  • headache
  • indigestion
  • weight loss
  • a high temperature with a low level of white blood cells (febrile neutropenia) 

Your doctor or a member of the study team will talk about the possible side effects of these drugs before you agree to take part. 
 

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:

16143

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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