A Randomised phase II trial of Enhancement of efficacy of Atezolizumab by Radiotherapy in Metastatic urothelial carcinoma
Disease Site: Bladder cancer, urological cancers, urothelial cancer
Treatment Modality: Systemic therapy, radiotherapy
Status: Open to recruitment
RE-ARM is a phase II, multicentre trial in metastatic urothelial carcinoma in patients already being treated with atezolizumab. The trial will assess if the addition of radiotherapy will enhance the efficacy of atezolizumab.
102 patients will be recruited from UK sites. Patients will either be allocated to continue to receive atezolizumab alone or to receive radiotherapy of 20 Gy in 5 fractions during their first cycle of on trial atezolizumab. All patients will continue to receive atezolizumab for up to 2 years or until there is no longer a clinical benefit.
Chief Investigator: Professor Robert Huddart, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust
ICR-CTSU Scientific Lead: Professor Emma Hall
Trial management contact: [email protected]
Sponsor: The Institute of Cancer Research
Funding: CRUK (CRUKE/19/009) and Roche Products Ltd
A lay summary in plain English is available from Cancer Research UK
Publications and Presentations
A. Wilkins, E. Hall, R. Lewis, H. Gribble, A. Melcher, R. Huddart. RE-ARMing the Immune Response to Bladder Cancer with Radiotherapy, Clinical Oncology, 2022
R. Huddart, R. Lewis, S. Brown, E. Cheadle, A. Choudhury, S. Crabb, C. Emery, H. Gribble, J. Haviland, T. Illidge, M. Linch, H. Scowcroft, A. Sohaib, I. Syndikus, R. Walshaw, A. Wilkins, A. Melcher, E. Hall - RE-ARM – a multicentre phase II randomised controlled trial of radiotherapy plus atezolizumab in metastatic urothelial carcinoma – investigating the abscopal effect. Presented at: National Cancer Research Institute Cancer Conference; 2021 Nov 8-12