A multi-stage randomised trial of durvalumab (Medi4736) with chemoradiotherapy with 5-fluorouracil and mitomycin C in patients with muscle-invasive bladder cancer.

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Study Overview and Summary

Chief Investigator: Professor Nicholas James
Sponsor: University of Birmingham
Funders: AstraZeneca UK Ltd
Disease Site: Bladder Cancer
Study Type:

Chemoradiotherapy /Immunotherapy/ Phase II Randomised, clinical trial of Investigational Medicinal Product (CTIMP)

Status: Open 
UKCRN Study ID: (if applicable)  N/A
ISRCTN Referance Number:  43698103
Open to new sites? Yes
Recruitment start date:  9th October 2020
Anticipated Recruitment end date  31st October 2024
CRCTU Study Management Team: Late Phase Trial Management Team A
Study E-mail Address:

Study Summary

Bladder cancer is the ninth most common cancer diagnosed worldwide. Approximately 24% of newly diagnosed patients have muscle invasive bladder cancer (cancer that has grown into the muscle layer of the bladder wall). Five-year survival rates are around 45%. The current standard treatment for muscle invasive bladder cancer consists of a combination of radiotherapy and low dose chemotherapy using two drugs: 5-Fluorouracil (5FU) and mitomycin C (MMC). This type of treatment is known as chemoradiotherapy.

Researchers have found that the body’s own immune system may slow down or control cancer growth. Sometimes however, this response stops and the cancer is not killed by the immune system. This is because some patients’ cancer cells start to produce proteins that stop the body’s immune system from recognising and killing them. Programmed Death Ligand 1 (PD-L1) is one such protein. Durvalumab, a so called immunotherapy agent, is a type of drug called a monoclonal antibody that is designed to bind to and inactivate PD-L1 thus increasing the immune response. It is hoped that by blocking this protein the immune cells will once again be able to slow down cancer growth. Durvalumab is licenced for use in the UK for the treatment of certain types of non-small cell lung cancer and is licenced in the USA for bladder cancer, and it is being tested alone or combined with other treatments in a number of other cancers. A US study in cancer of the bladder has shown that concurrent durvalumab and radiotherapy followed by durvalumab is well tolerated. Immunotherapy with drugs like durvalumab is already approved in the UK for patients whose cancer returns after initial treatment with radiotherapy. Recent research has shown that radiotherapy also has the ability to boost the body’s immune response to cancer cells. Hence, there is interest in combining immunotherapy with radiotherapy to further increase anti-tumour responses and thus lead to improved outcome.

In the RadIO trial we are going to compare standard chemoradiotherapy treatment to standard chemoradiotherapy treatment given in combination with durvalumab to see if the addition of durvalumab leads to improved survival.

Please note that the trials team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.

Study Protocol

Clinical study protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional or refer to the CancerHelp website.

Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference. 

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