This clinical study is exploring an investigational immunotherapy for patients with colorectal cancer who have previously undergone surgery followed by chemotherapy.

The study drug is individualised.

This means that the study drug is made based on the genetic information from the patient’s tumour removed during surgery.

The study will assess whether the investigational immunotherapy can help 'train' the immune system to recognise and attack any remaining cancer cells…with the aim of reducing the possibility of the cancer coming back.

The study is split into three periods:

Screening,

Treatment,

and Follow-up.

The first part of the Screening Phase will take place after surgery but before chemotherapy starts.

The study doctor will review the patient’s medical history and eligibility for the trial, provide more information, and ask the patient whether they want to take part in the study.

If the patient is interested in participating, a blood sample will be taken, and analysed for a biomarker called circulating tumour DNA, or for short, ctDNA

The test used in this clinical study is for investigational use only.

If ctDNA is seen in the blood sample, the patient can continue screening.

The screening will continue during and after chemotherapy, including two more screening visits with additional tests, including a CT or MRI scan.

If the study doctor confirms that the patient is eligible for the study, and the patient still wishes to take part, they will be randomly allocated to one of two groups as part of the treatment phase.

One group, the treatment group, will receive the investigational immunotherapy.

The other group will continue with an observation period called ‘Watchful Waiting’, which is the current standard medical practice.

Patients in the treatment group will receive 15 doses of the study drug over 12 months.

After the treatment phase, all patients will enter the follow up phase.

Everyone taking part will be monitored closely with a scan every 3 months until the end of the study.

Participation in the clinical trial is entirely voluntary, and patients may leave the study at any time without giving a reason.

If you would like more information, please speak to your doctor or contact us through our website.