First patient recruited into REFINE

The REFINE trial “Renal Cohort” recruited its first patient today.

This UK-based trial is testing if giving a type of drug less often to patients with advanced cancers, results in fewer side effects whilst still being effective.

The drug is an immune checkpoint inhibitor, which boosts the body’s immune system to recognise and attack cancer cells. This question will be assessed in different tumour types, including renal cancer and melanoma.

Clinical trials have already shown that checkpoint inhibitors are effective in the treatment of different cancers. Currently, the drugs are injected intravenously every few weeks, which means that patients need to visit the hospital frequently to receive treatment and take follow-up tests to monitor their condition.

However, the best frequency to give these drugs is not currently known.

There is some evidence suggesting that checkpoint inhibitors carry on working in the body after an injection for longer than we previously thought. This means that we could give the drugs less often and still have the same effect on the cancer. Patients given checkpoint inhibitors less often could have a better quality of life, with fewer side effects and fewer hospital visits. For the NHS this also means that an effective treatment could be provided at a lower cost, potentially allowing more patients to be treated.

To assess this, the REFINE trial is testing different time intervals between injections. It is designed as a multi-stage trial. In stage I, adults with advanced renal cancer treated with checkpoint inhibitors will be randomly assigned to receive either:

• Standard schedule – drug is injected every 4 weeks
• Extended schedule – drug is injected every 8 weeks

 

We will use the same trial design for the different tumour cohorts. The Renal Cohort is currently open for recruitment in three hospital sites, and it will expand to more sites in the near future. The Colorectal and Melanoma Cohorts will open next.

 

In stage I the trial aims to recruit 160 participants per cancer type. We hope to have the first results from the REFINE trial in 2025.