NEOPRISM-CRC
Research type
Research Study
Full title
Neoadjuvant pembrolizumab stratified to tumour mutation burden for high risk stage 2 or stage 3 MMR-deficient colorectal cancer
IRAS ID
1003601
Contact name
Reshma Bhat
Contact email
Sponsor organisation
University College London
Eudract number
2020-000040-58
Clinicaltrials.gov Identifier
Research summary
Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called ‘immune checkpoint inhibitors’ have shown excellent results in advanced CRC patients who have certain genetic characteristics called 'mismatch repair deficiency (MMR-d)' and 'high microsatellite instability (MSI-h)'. The benefits of immunotherapy as a treatment prior to surgery to remove the tumour (neoadjuvant treatment) has been observed in both melanoma (skin cancer) and in glioblastoma (a type of brain tumour) with enhanced local and systemic anti-tumour responses.
The NEOPRISM-CRC trial will investigate whether giving pembrolizumab before surgery is safe, whether it improves the chances of the tumour being removed completely, and whether this delays or prevents the cancer from coming back. Pembrolizumab is an immunotherapy drug and works by helping the body's own immune system to fight the cancer cells.
Pembrolizumab treatment lasts for a maximum of 9 weeks (one cycle every 3 weeks) and is given before surgery. After surgery patients will be followed up for at least 3 years and to a maximum of 5 years. Thirty two patients will be recruited to the trial.
Blood, tissue, tongue swabs and stool samples will be collected from patients throughout the trial to better understand the biology of immunotherapy as a treatment for CRC prior to surgery.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0216
Date of REC Opinion
17 Oct 2021
REC opinion
Further Information Favourable Opinion