
“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 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:
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 fight cancer.
The researchers are combining PDR001 with:
These are all .
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 called TP53 work. TP53 can stop cancer cells growing and might even kill them.
The aims of this study are to find:
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:
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:
Who can’t take part
You cannot join this study if any of these apply.
Cancer related
You:
Medical conditions
You cannot join the study if any of the following apply. You:
Other
You cannot join this study if any of the following apply. You:
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:
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 ():
They take blood samples before starting treatment and during treatment.
They use these blood and tissues samples to find out:
You see the doctor to have some tests when you agree to take part. These tests include:
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 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:
They will ask about how you are and if you have started any other anti cancer treatment.
Your doctor and nurse will monitor you closely for any side effects. Let your doctor or nurse know as soon as possible if:
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:
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.
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.”