REFINE
Research type
Research Study
Full title
A multi-arm phase II basket protocol testing reduced intensity immunotherapy across different cancers
IRAS ID
298208
Contact name
Duncan Gilbert
Contact email
Sponsor organisation
Medical Research Council Clinical Trials Unit at UCL
Eudract number
2021-002060-47
ISRCTN Number
ISRCTN79455488
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Immune checkpoint inhibitors are a type of drug used to treat patients with advanced cancers. They help the body’s immune system find cancer cells. The immune system is important in fighting infections and cancer. Immune checkpoint inhibitors can stop cancers growing for many months or years.
Immune checkpoint inhibitors are given to patients through an injection into a vein every 3-6 weeks in a hospital or clinic. Blood tests are needed before each injection. This means that patients spend a lot of time (and money) on hospital visits. The drugs are expensive costing many thousands of pounds per month and use a lot of hospital resource.
It is now thought that immune checkpoint inhibitors work for a longer period of time than originally thought. This means it may be possible to give the drugs less often and still have the same effect on the cancer.
The unwanted side effects of these drugs are unlike those of traditional chemotherapy drugs as they may cause auto-immune problems. This means that the patients’ immune system attacks their normal tissues. The relationship between dose of drug and side-effect is not clear but it is possible that giving the drugs less often might limit the side-effects experienced by patients.
REFINE is a clinical trial that tests whether patients can receive these drugs less often whilst getting the same benefit in terms of treating their cancer. The Refine trial is an initial test of this concept that may lead to a larger trial in due course. The REFINE trial aims to understand the benefits to patients and to the health service from this approach. REFINE will start by testing this in a group of patients with advanced kidney cancer or melanoma but will then test this approach in patients with a range of other tumour types.
REC name
London - Westminster Research Ethics Committee
REC reference
21/LO/0593
Date of REC Opinion
19 Oct 2021
REC opinion
Further Information Favourable Opinion