||Professor Nicholas James
||University of Birmingham
||AstraZeneca UK Ltd
Chemoradiotherapy /Immunotherapy/ Phase II Randomised, clinical trial of Investigational Medicinal Product (CTIMP)
|UKCRN Study ID: (if applicable)
|ISRCTN Referance Number:
|Open to new sites?
|Recruitment start date:
|| 9th October 2020
|Anticipated Recruitment end date
|| 31st August 2022
|CRCTU Study Management Team:
||Late Phase Trial Management Team A
|Study E-mail Address:
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.
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