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

Trial Details

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.

Further information for healthcare professionals

Protocol

Further Information

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]

ISRCTN: ISRCTN12606219

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