A trial looking at using a new drug called defactinib with an immunotherapy drug (pembrolizumab) to treat advanced cancers.
Full title: A Phase 1/2a study to assess safety, tolerability and preliminary activity of the combination of FAK inhibitor (defactinib) and anti-PD-1 (pembrolizumab) inhibition in patients with advanced solid tumours.
Why is this trial being carried out?
The immune system fights diseases, but it can’t always protect you from cancer. When someone is diagnosed with cancer it means that cancer cells have managed to disguise themselves, or hide from the immune system. Immunotherapy works by stimulating the body’s immune system to recognise and attack the cancer cells.
The FAK-PD1 trial will look at using a drug called defactinib alongside an immunotherapy drug. The trial will see if this is a good treatment option for advanced cancer and if it is safe to use. The trial will look at three different types of advanced cancer, which are all in need of better treatment options. One of these cancer types is advanced pancreatic cancer. Advanced pancreatic cancer is cancer that has spread to other parts of the body, away from the pancreas.
The two drugs being studied are defactinib and pembrolizumab. Pembrolizumab is already used to treat some types of cancer, but this is the first time defactinib and pembrolizumab will be used together.
What does this trial involve?
The FAK-PD1 trial is split into two groups. The different groups depend on which of the three types of advanced cancer you are affected by. People affected by advanced pancreatic cancer will be in one group, and people affected by the other two types of advanced cancer will be in the second group.
People affected by advanced pancreatic cancer will be given pembrolizumab and defactinib at the same time. Pembrolizumab is given by an infusion into your veins once every three weeks. An infusion is when the drug is given directly into your veins – you may hear this being called a ‘drip’.
When you receive pembrolizumab, you will also begin taking defactinib. You will take a defactinib tablet twice a day, every day. The trial can last for up to two years, as long as the treatment is helping you and you don’t have any bad side effects.
Before taking part in the trial you will need to have some tests, such as blood tests, an MRI scan or a CT scan, to check if you are able to take part in the trial. You will also have these tests during the trial to see how well the treatment is working.
You may also be asked to give a tissue sample, which will be taken by a biopsy. A biopsy may be taken before you start the trial, and after 14 days of treatment on the trial. You do not have to have a biopsy if you do not want to, and you can still take part in the trial if you decide not to have one. Speak to your doctor or nurse about this.
Who is the trial suitable for?
- you have been diagnosed with advanced pancreatic cancer, advanced mesothelioma or advanced non-small cell lung cancer
- your cancer is not responding to other treatments
- you are well enough to take part in the trial – you will have tests to check this.
The FAK PD-1 trial may not be suitable for you if:
- you have had another cancer in the last 5 years that has not been successfully treated – this does not include some types of skin cancer, prostate cancer or cervical cancer
- your cancer has spread to your brain – unless this is controlled with treatment and you have not needed a steroid in the last month
- you struggle to swallow or absorb medicines that are taken by mouth
- you have previously been treated with an pembrolizumab, or a similar immunotherapy drug
- you have taken part in a clinical trial or had chemotherapy in the last 4 weeks
- you have bad side effects from your previous treatment, such as nausea or fatigue, that have not been resolved – this does not include hair loss
- you have had a live vaccine in the last 4 weeks
- you have a known history of tuberculosis, HIV or hepatitis
- you have an immunodeficiency or have been treated for an autoimmune disease in the past 2 years
- you have a known lung problem.
There may be other reasons for not being able to take part in a trial. It is important to speak to your doctor about whether this trial might be suitable for you.
Recruitment start date: July 2017
Recruitment end date: May 2019
The FAK-PD1 trial is being carried out at:
- Southampton General Hospital
- Beatson West of Scotland Cancer Centre, Glasgow
- Belfast City Hospital, Northern Ireland
- Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh
To learn more about this trial and contact the trial centres, please discuss this with your medical team.
How to join a trial
Speak to your consultant about whether this trial is suitable for you.
If you have any questions about pancreatic cancer you can speak to one of our specialist nurses on our Support Line.
How to find out more
For further information about this trial please visit the ClinicalTrials.gov website.
For references used to develop this information please email us.
Published: November 2018
Review Date: November 2020