Neo-POLEM
Research type
Research Study
Full title
A phase II trial of neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI high colorectal cancer
IRAS ID
1008650
Contact name
Tony Dhillon
Contact email
Sponsor organisation
University of Southampton
Research summary
Early stage colon cancer that has spread to the local lymph nodes is best treated with surgery and chemotherapy. This will cure some of these patients. However, up to half of these patients will have a subsequent recurrence of their cancer. If this happens then the cancer is often incurable. We therefore need better treatments to stop recurrence happening and to improve the initial chance of cure. About 1 in 7 colon cancers have 'defective mismatch repair'. This means that more mutations and 'errors' are present in the cancer of these patients than is seen in other colon cancer. Recent small trials of immunotherapy drugs that stimulate the immune system to attack the cancer appear to work exceptionally well in this subtype of colon cancer. We need larger trials to confirm the results are accurate, therefore we are undertaking Neo-POLEM for this subtype of colon cancer. However, we will treat these patients in a different way. Rather than giving an immunotherapy drug that would need to be given for longer potentially, we will use a vaccine approach that we hope will have a durable effect. This vaccine is designed to work by stimulating the immune system to attack the patient’s cancer and we predict that this subtype of cancer may be particularly sensitive to this approach. We will give the vaccine before surgery as this will allow for collection of tumour samples both before and after the vaccine is administered.
Recruited patients will receive 3 doses of the vaccine, 2 weeks apart, prior to having their standard surgery. They will be monitored throughout the vaccine period and during follow up through blood tests, physical exams and CT scans. Following surgery, patients may have further chemotherapy if residual disease is present. We will follow up all patients for a minimum of 2 years from surgery.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
24/EE/0180
Date of REC Opinion
18 Oct 2024
REC opinion
Further Information Unfavourable Opinion