REFINE trial opens their melanoma cohort

The melanoma cohort of REFINE has opened to participants.

The REFINE trial is looking at whether giving immunotherapy less often is as effective at treating advanced cancer than the current treatment. It will look initially at patients with kidney (renal) and melanoma cancers.    

Immunotherapy is a type of cancer treatment that uses drugs called checkpoint inhibitors. Checkpoint inhibitors work by helping the body’s natural defence (immune system) to recognise and attack the cancer cells. These drugs are injected into a vein in the patient’s arm, in a hospital or clinic every few weeks.  

REFINE is a phase II randomised clinical trial. It is designed as a multi-stage trial. The first phase will compare two different time intervals between immunotherapy injections, to find out if a longer interval between injections is as effective as the current interval schedule.  

The rationale behind this hypothesis is that researchers think that checkpoint inhibitors work for longer than anticipated. By giving these drugs less often we could improve the quality of life of patients without compromising the benefit they receive from the treatment. That would result in less hospital visits, and potentially, fewer side effects from the treatment.  

The melanoma cohort is now recruiting patients with advanced melanoma, which is a type of skin cancer that has spread elsewhere in the body. The renal cohort started recruiting in August 2022.  

Currently, patients with advanced melanoma are treated with either a combination of two immunotherapy drugs (ipilimumab + nivolumab) or with just one (pembrolizumab). To investigate if giving injections less often is as effective as the current schedule, trial participants will be randomly allocated to one of the groups: 

• Standard interval: nivolumab every 4 weeks or pembrolizumab every 6 weeks, depending on the immunotherapy drug they are receiving
• Extended interval: nivolumab every 8 weeks or pembrolizumab every 12 weeks (I.e. less often), depending on the immunotherapy drug they are receiving

The melanoma cohort aims to recruit 160 participants. 

To inform and improve the ways we deliver immunotherapy treatment to patients with cancer, we are also carrying out the OPTIC study. As part of it, we are talking to patients and carers about their views on how we give immunotherapy. Understanding their experiences will help us improve the way we run future cancer trials.  

REFINE is funded by The Jon Moulton Charity Trust and the Medical Research Council.