RecruitingPHASE2INTERVENTIONAL

NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer

The NEOPRISM-CRC study is for people with bowel cancer that has certain genetic features. This type of bowel cancer can sometimes be treated well with drugs that boost your immune system. The study is investigating if giving a drug called pembrolizumab *before* surgery can improve how well the cancer is removed and stop it from returning. Pembrolizumab works by helping your body's immune system fight the cancer cells. Researchers want to see if this treatment is safe, helps the surgery be more successful, and could offer a better outcome for patients.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University College, London

Enrolment target

Start

20 Jul 2022

Estimated completion

31 Jul 2029

Adenocarcinoma of the Colon

What is this study about?

Bowel cancer is a common type of cancer. For many people, the main treatment involves surgery to remove the tumour. However, even after successful surgery, the cancer can sometimes come back or spread, which is much harder to treat. Scientists have found that a specific type of bowel cancer, which has certain genetic features (often called 'MMR-deficient' or 'MSI-high'), responds well to medicines known as 'immunotherapy'. These drugs, like pembrolizumab, work by helping your own immune system recognise and attack cancer cells.

This study, called NEOPRISM-CRC, wants to find out if giving pembrolizumab *before* surgery for this specific type of bowel cancer can make a difference. The idea is that the drug might shrink the tumour or make it easier to remove completely during surgery. Researchers are also hoping it could reduce the chances of the cancer returning later on. They will be carefully watching to see if the treatment is safe, how well it works, and if it improves patients' quality of life.

This is a 'Phase 2' study, which means it's testing a new approach that has shown promise in earlier research for advanced cancer. It aims to recruit about 88 patients over four years. If successful, this approach could offer a new and better way to treat bowel cancer with these specific genetic features.

Key takeaways

This study tests an immunotherapy drug (pembrolizumab) for bowel cancer *before* surgery.
It's for a specific type of bowel cancer with certain genetic features.
The goal is to improve surgery success and prevent cancer recurrence.
Treatment lasts up to 9 weeks before surgery, followed by long-term monitoring.
It's a Phase 2 study, exploring a promising new treatment approach.
Patients will provide samples to help understand the drug's effects.

Who may be eligible?

To join this study, you would need to have been diagnosed with bowel cancer that has specific genetic features, often called 'MMR-deficient' or 'MSI-high'. You should also be fit enough for surgery and for chemotherapy if it's needed after surgery, as decided by your doctors.

Your cancer needs to be at a certain stage – either Stage 2 with a high risk of coming back, or Stage 3. If you have rectal cancer, you can still join if your doctors don't think you need radiotherapy and chemotherapy before surgery. People who have had a blockage in their bowel can join, but only after it's been sorted out and they've recovered. You also need to be at least 18 years old and have good organ function, including your blood, kidneys, and liver.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have bowel cancer that your doctor says is 'MMR-deficient' or 'MSI-high'?
Are you generally fit enough for surgery and potentially chemotherapy?
Is your cancer considered Stage 2 (high risk) or Stage 3?
Are you at least 18 years old?
Do you have good overall health, especially kidney, liver, and blood function?
If you have rectal cancer, does your doctor confirm you don't need pre-surgery radiotherapy and chemotherapy?

Answer every question to see your result.

What does participation involve?

If you join the study, you'll receive pembrolizumab treatment for up to 9 weeks (which is a maximum of 3 doses, with each dose given every three weeks). This treatment will happen *before* your surgery. After your surgery, doctors will keep a close eye on you for at least 3 years, and up to 5 years, to see how you're doing and if the cancer returns.

Throughout the study, you'll be asked to provide various samples, such as blood, tissue from your tumour, mouth swabs, and stool samples. These samples will help the researchers understand more about how the treatment works and why it helps some people more than others. Your doctors will also check for any side effects and how the treatment affects your overall wellbeing.

Potential risks and benefits

Potential benefits of joining include receiving a treatment that might improve the success of your surgery and reduce the chance of your cancer returning. This study could help find a new and better way to treat bowel cancer for people with your specific type of disease. However, like all medicines, pembrolizumab can have side effects, which your doctor will explain in detail. There's also no guarantee the treatment will work for everyone, and it might not prevent your cancer from coming back. You are free to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Addenbrookes Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Beatson West of Scotland Cancer Centre
Verified postcode
Glasgow, United Kingdom· Recruiting
St James University Hospital (SJUH)
Verified postcode
Leeds, United Kingdom· Completed
University College Hospital
Verified postcode
London, United Kingdom· Recruiting
Christie Hospital NHS Trust, Wilmslow Road,
Verified postcode
Manchester, United Kingdom· Recruiting
Southampton General Hospital
Verified postcode
Southampton, United Kingdom· Completed

Common questions

What is pembrolizumab and how does it work?

Pembrolizumab is an immunotherapy drug. It helps your body's immune system recognise and fight cancer cells more effectively.

Why is this treatment given before surgery?

Researchers want to see if giving the drug before surgery can shrink the tumour, make surgery more successful, and reduce the chances of the cancer coming back.

How long will the treatment last?

You will receive pembrolizumab for a maximum of 9 weeks (3 doses) before your surgery.

What kind of follow-up will I need?

After your surgery, you will be followed up by the study team for at least 3 years, and up to 5 years, to monitor your health.

What are 'MMR-deficient' or 'MSI-high' bowel cancer?

These are specific genetic features found in some bowel cancers that indicate they might respond well to immunotherapy drugs like pembrolizumab.

How to find out more

Reshma Bhat

ctc.neoprism@ucl.ac.uk 02076799336 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.