A Phase II trial assessing nivolumab in class II expressing microsatellite stable colorectal cancer



Study Overview and Summary

Chief Investigator: Professor Gary Middleton
Sponsor: University of Birmingham
Funders: Bristol Myers Squibb
Disease Site: Metastatic/Locally Advanced Colorecatal Cancer
Study Type:

An open-label, single arm, phase II, multicentre clinical trial 

Status:  Open
UKCRN Study ID: (if applicable)  N/A
ISRCTN Referance Number:  40245896
Open to new sites? Yes
Recruitment start date:  28-Aug-2019
Recruitment end date  06-Sep-2021
CRCTU Study Management Team: Early Drug Development (EDD) Team
Study E-mail Address:
Study Summary

Immuno-oncology is transforming the care of certain patients with cancer. Not all patients respond to these therapies however, and in some common cancers checkpoint blockade has failed to make any real impact. In 2014 there were over 41,000 new cases of colorectal cancer (CRC) in the UK and nearly 16,000 deaths from the disease, making it the second commonest cause of cancer death (Cancer Research UK Cancer Statistics Key Facts).

Previous trials have shown that a small number of colorectal tumours with certain genetic problems identified in the laboratory, known as microsatellite instability, (MSI) respond well to drugs like nivolumab. However, most people with colorectal cancer particularly those with metastatic disease (around 95%) will not have this particular genetic problem in their tumour; these tumours are known as microsatellite stable (MSS) and these drugs do not work as well for these patients. Another immunohistochemistry test has been developed to assess the level of a molecule called class II in colorectal tumours. We think that MSS colorectal tumours with high levels of class II molecules might respond better to nivolumab, in the same way that MSI tumours respond. Class II molecules are the molecules that show abnormal proteins made by cancer cells and the immune system. We estimate that about 1 in 10 people tested, who have MSS tumours, will have a high level of the class II molecule.

Please note that the study team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Study Protocol

Clinical study protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional or refer to the Cancer Research UK website, see link below.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference. 

  • Protocol is available on request.
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