RE-ARM Version 1.0
Research type
Research Study
Full title
A Randomised phase II trial of Enhancement of efficacy of Atezolizumab by Radiotherapy in Metastatic urothelial carcinoma
IRAS ID
280335
Contact name
Deborah Gardiner
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2020-004893-23
ISRCTN Number
ISRCTN12606219
Duration of Study in the UK
5 years, 0 months, 1 days
Research summary
RE-ARM is a clinical trial for people who are already receiving treatment with a drug called atezolizumab for bladder or urinary system cancer (urothelial cancer) which has spread to other parts of their body (metastasised). RE-ARM investigates whether giving additional radiotherapy alongside atezolizumab can improve how well it works.
Atezolizumab is an immunotherapy drug which enhances the body’s natural immune response against cancer. It normally starts working after the first few weeks of treatment, but it can start working later on (late response), even if at the start there was no clear effect.
Radiotherapy can also improve the body’s cancer immune response. Previous studies suggest radiotherapy can be given safely in combination with immunotherapy and it may make it more likely to work. The RE-ARM study will assess whether giving people a short course of radiotherapy while they’re still taking atezolizumab will increase the number who then have a late response.
People receiving atezolizumab for metastatic urothelial cancer will be approached by their NHS hospital cancer care teams about participation in RE-ARM. 102 participants will be enrolled and assigned to one of two groups at random. Half (51) will continue taking atezolizumab on its own. The other half will continue atezolizumab alongside a short course of radiotherapy targeted at one site of their cancer. Participants in both groups will continue to receive atezolizumab every three weeks until it is no longer helping to keep their cancer under control.
Participants will have check-ups every three weeks to check and treat any symptoms they may be having and scans every 9-12 weeks to check whether their cancer is responding to treatment. This schedule is based on the standard treatment and monitoring schedule used for atezolizumab. After people stop their atezolizumab treatment patients will continue to be followed up every 3 months
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0150
Date of REC Opinion
9 Mar 2021
REC opinion
Further Information Favourable Opinion