A study of MRx0518 before surgery for solid tumours (MICROBIOME)

Cancer type:

Bladder cancer
Breast cancer
Head and neck cancers
Kidney cancer
Lung cancer
Melanoma
Ovarian cancer
Prostate cancer
Womb (uterine or endometrial) cancer

Status:

Open

Phase:

Phase 1
This study is looking at a new treatment called MRx0518 for solid tumours. 
 
A solid tumour Open a glossary item is any type of cancer apart from blood cancers such as:
  • leukaemia Open a glossary item 
  • lymphoma Open a glossary item 
  • myeloma  Open a glossary item

More about this trial

Researchers are looking for new ways to treat people who have cancer. In this study, they are looking at a treatment called MRx0518. 
 
MRx0518 is a bacterium or a pro biotic. It is made up of a bacterium Open a glossary item called Enterococcus gallinarum. This is found in the bowels of most people. And it is part of the ‘normal gut flora’ or the microbiome. This is made up of bacteria, fungi or viruses. These bacteria help digest our food, control our immune system Open a glossary item and protect against other bacteria that cause disease. Enterococcus gallinarum is also found in foods such as cheese and olives. 
 
Some very early studies suggest that MRx0518 might stimulate the body’s own immune system to attack and kill cancer cells. But researchers aren’t sure, so they want to find out more.
 
In this study, some people will have MRx0518. And some people have a dummy drug (placebo Open a glossary item). This is the first time people are having MRx0518.
 
The main aims of the study are to find out:
  • how safe MRx0518 is
  • if it stimulates the immune system to kill cancer cells
  • if MRx0518 works for people with solid tumours
  • if biomarkers Open a glossary item can predict who treatment works best for
Please note, you might not get any direct benefit from taking part in this study. But taking part will help work out if and how MRx0518 works.

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 1 of the following types of cancer. 
As well as the above, the following must also apply.
 
You: 
  • are due to have surgery to remove the cancer 2 to 4 weeks after treatment
  • can swallow and keep medication down
  • are willing to use reliable contraception for at least 28 days before starting treatment, during treatment and for 3 months after last dose for men and one complete menstrual cycle for women if there is any chance you or your partner could become pregnant 
  • have satisfactory blood test results  
  • are well enough to be up and about for at least half the day (performance status 0,1 or 2)
  • 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 had cancer treatment in the last 2 years 
  • have cancer of the digestive system Open a glossary item such as the stomach or bowel or if you might need to have part of your bowel removed
  • are having an experimental cancer treatment or any other treatment for cancer 
  • have cancer that has grown into surrounding tissue and it isn’t possible to remove it with surgery 
Medical conditions
You: 
  • have heart problems such as a problem with the valves in the heart, congestive heart failure or any other serious heart problem 
  • have a feeding tube into the stomach, an abnormal opening in the stomach (a fistula) or inflammatory bowel disease such as a condition called ulcerative colitis
  • have a problem with your immune system Open a glossary item or you are having medication to dampen down your immune system
  • have a problem with your digestive system Open a glossary item that means you won’t be able to absorb the study medication 
  • have an active infection
  • have an active hepatitis B or hepatitis C infection
  • have HIV
  • have had antibiotics with 4 weeks of starting study treatment 
  • have had flu, a fever, meningitis or an infection within 4 weeks of starting study treatment
  • have any other medical condition or mental health problem that the study team think would affect you taking part
Other
You: 
  • drink a lot of alcohol (more than 14 units each week)
  • smoke or use nicotine, this includes e cigarettes 
  • are allergic to MRx0518 or anything it contains
  • are allergic to amoxicillin (clavulanic acid), erythromycin and imipenem 
  • are pregnant or breastfeeding 

Trial design

This is a phase 1 study. It is the first time people are having MRx0518. The researchers need 120 people to take part. The study is taking place at Imperial College London. 
 
This study is in 2 parts:
  • part A is testing how safe MRx0518 is to have in a few people 
  • part B will test it in more people
Part A is open. Part B isn’t open yet. 
 
20 people join part A. About 100 people will join part B when it opens. MRx0518 and the dummy drug are capsules. 
 
Part A
You have 2 MRx0518 capsules. An independent data safety monitoring committee Open a glossary item will then review the information (data) to see how safe the treatment is. 
 
Part B
Part B begins when they have reviewed the information from part A. You may have 3 capsules or 1 depending on their findings. 
 
Part B is randomised. You are put into treatment groups by a computer. Neither you nor your doctor will be able to decide which group you are in. Nor will you know which treatment you are having. This is called a double blind trial. 
 
In Part B, you have 1 of the following:
  • MRx0518
  • dummy drug (placebo Open a glossary item)
You are 4 times more likely to have MRx0518. 
 
You have the first dose at the hospital. You have treatment for 2 to 4 weeks. You have the rest of the treatment at home. Your doctor will tell you how often to take the capsules.  
 
When you start treatment, the team will give you a diary and a thermometer. They’ll ask you to write in it: 
  • when you take the capsules
  • your temperature twice a day
  • any side effects
They’ll also ask you to record your bowel movements on certain days. 
 
When you finish treatment, you’ll have your surgery as planned. Your doctor can tell you more about this. 
 
When the study finishes you give:
  • blood samples
  • poo samples 
  • urine samples
Samples for research
You give some extra blood samples during treatment. You give the samples at specific times and the study team will give you more information about this. They plan to use the samples to:
  • see how well the treatment is working
  • look for biomarkers Open a glossary item to predict who will benefit from treatment
The doctors will ask permission to collect a tissue sample during surgery. 

Hospital visits

You’ll see a doctor and have some tests before you can take part. Some of these include:
  • physical examination
  • blood samples
  • urine samples
  • pregnancy test
  • heart trace (ECG Open a glossary item)
  • poo samples
  • giving information about what you usually eat and drink 
You have up to 6 hospital visits before surgery. At some visits you give:
  • blood samples
  • a urine sample
  • a poo sample (you can collect this at home before you go to the  hospital)
When you finish treatment, you see the study team for a check up at:
  • 30 days
  • 6 months
  • 12 months
  • 2 years
At each visit you give:
  • blood samples
  • a urine sample
  • a poo sample (you can collect this at home before you go to the hospital)

Side effects

This is the first time people are having MRx0518. So, there may be some side effects we don’t know about yet. The study team will monitor you during the time you have treatment and you’ll have a phone number to call if you are worried about anything. 
 
The possible side effects of MRx0518 include:
  • urine infections
  • a bacterial infection in the blood 
  • inflammation of the layers of tissue that surround the brain (meningitis)
  • a serious infection of the blood (sepsis)
  • wound infections
Please contact your study doctor if you develop a temperature of 38.5 ˚C or above. Or 2 temperatures in a row of 38˚C or higher in a 12 hour period. 

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

Dr Jonathan Krell

Supported by

4D Pharma Research Limited 
Imperial College London 

 

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

16083

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

Cara took part in a clinical trial

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"I am glad that taking part in a trial might help others on their own cancer journey.”

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