A phase II colorectal cancer trial for patients coordinated by UCL CTC has met its recruitment target within 16 months of opening.
The NEOadjuvant PembRolizumab In Stratified Medicine – ColoRectal Cancer (NEOPRISM-CRC) trial opened to recruitment in July 2022 for patients who are diagnosed with early-stage and a specific genetic subtype of colorectal cancer. 32 patients were enrolled onto the trial from 4 NHS Trusts across England.
Colorectal cancer is the third most common cancer in developed countries, with over one million new cases and 500,000 deaths worldwide each year. The current treatment for early-stage colorectal cancer 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 which is incurable. Clinical trials using immunotherapy drugs have shown excellent results in patients with colorectal cancer who have certain genetic characteristics with 'deficiency in DNA mismatch repair (dMMR)' and 'microsatellite instability high (MSI-H)'. The NEOPRISM-CRC trial is investigating whether giving pembrolizumab (a type of immunotherapy drug) to dMMR/MSI-H colorectal cancer patients is safe, whether it shrinks the tumour and improves the chances of the tumour being removed completely at surgery, and if this then delays or prevents the cancer from coming back.
During their participation in the trial, patients were given pembrolizumab treatment before surgery for a minimum of 3 weeks and maximum of 9 weeks. Tumour tissue, tongue swabs, blood and stool samples were collected to help us understand how immunotherapy works as a treatment for colorectal cancer prior to surgery. Patients will be followed up for three years.
The trial is funded by Merck Sharp & Dohme UK and sponsored by UCL.
Dr Kai-Keen Shiu, based at University College London Hospitals NHS Foundation Trust and UCL Cancer Institute, is the trial’s Chief Investigator and remarked:
NEOPRISM-CRC is a trial that I first thought about in 2019 and am proud of my clinical and research teams at UCLH and UCL, as well as my co-investigators around the country who have helped me create and deliver this study. Most of all, I am thankful for the patients who have participated in the trial so far and benefited from this treatment.
NEOPRISM-CRC was also created as a translational platform to better understand tumour immune-biology. In collaboration with research teams nationally and around the world, we will accelerate our understanding and optimise treatment strategies for patients living with dMMR/MSI-High bowel cancer over the next few years.
I am pleased that the preliminary results have been accepted to be presented at the ASCO conference (hosted in Chicago) in June 2024. In addition, the trial has received extra funding so that more patients can be enrolled over the next 12-18 months from 5 centres across the UK. This will help provide the extra results needed for what the whole team hope will become a practice changing standard of care treatment in the near future.’
When the trial resumes recruitment in the next couple months, it will be open at University College London Hospitals NHS Foundation Trust, The Leeds Teaching Hospitals NHS Trust, The Christie NHS Foundation Trust and University Hospital Southampton NHS Foundation Trust in England, and Beatson West of Scotland Cancer Centre (NHS Greater Glasgow and Clyde).
Image: Micrograph of a colorectal carcinoma, Mikael Häggström