iSCORE
Research type
Research Study
Full title
iSCORE: Immunotherapy Sequencing in COlon and REctal Cancer.
IRAS ID
247730
Contact name
Starling Naureen
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Eudract number
2018-002250-79
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Cancers of the colon and rectum are the second commonest cause of death related to cancer in the EU and North America. Despite improvements in treatment of these cancers, the percentage of patients whose cancer has spread (this spread is referred to as metastatic cancer) from the location of the initial tumour in the colon or rectum and are alive after 5 years (from date of diagnosis) is about 12%. New treatments are urgently needed to improve the chance of survival for these patients.
Cancer cells within a tumour, or the environment in which the tumour exists, can change as the disease continues to develop and spread. This can be the reason why colorectal cancer which initially responded to FOLFIRI and Cetuximab treatment then stops responding. These changes include an increase in the number of cells which the immune system uses to fight cancer and certain proteins on the outside of the cancer cells which suggest that colon and rectal cancers might respond to Nivolumab and Relatlimab.
Immunotherapy is the term given to a group of anti-cancer drugs which work by stimulating patients’ own immune system to try to recognise and destroy cancer cells. Nivolumab and Relatlimab are immunotherapy drugs.
Nivolumab is an antibody (a type of human protein) which allows the body’s immune system to work against tumour cells. Relatlimab is also an antibody that works with the body’s immune system however this drug uses a different approach (pathway).
iSCORE is a phase II clinical trial, which will be carried out at The Royal Marsden Hospital. This study is open to patients with advanced cancer of the colon or rectum which initially appeared to become smaller while they were having treatment with FOLFIRI and Cetuximab treatment but now has either grown, reappeared or spread to another part of the body. The main aim of the study is to see how effective Nivolumab and Relatlimab is in controlling cancer 6 months after starting treatment. This will be determined on a type of radiological scan, called a CT or MRI scan, which will be performed every 8 weeks for the first year and every 12 weeks for the second year. This study will also determine how safe and tolerable (how much any side effects can be sensibly tolerated) Nivolumab and Relatlimab treatment is for patients with colon and rectal cancers.
This study will be recruiting patients for a period of 30 months and it is expected that a total of 25 patients will be included in the study.
During this study patients are required to have tissue removed from their tumour (called biopsies) either by endoscopy (a tiny camera inserted into the colon or rectum) or an image-guided biopsy using an ultrasound scan or CT scan depending upon where their disease is. A total of 3 biopsies will be taken; within the 4 week period before starting on the study drugs, after the first dose of Nivolumab and Relatlimab treatment and also if the patient’s cancer worsens. These biopsies are critically important to help to understand the possible association between biological markers within tumour tissue and how well the study drugs work. In the future, this might help determine which people respond best to these study drugs.
REC name
London - City & East Research Ethics Committee
REC reference
18/LO/1673
Date of REC Opinion
18 Oct 2018
REC opinion
Favourable Opinion