PH II TRIAL OF TRIMODALITY THERAPY +/- DURVALUMAB IN BLADDER CANCER
Research type
Research Study
Full title
A RANDOMIZED PHASE II TRIAL ASSESSING TRIMODALITY THERAPY WITH OR WITHOUT ADJUVANT DURVALUMAB (MEDI4736) TO TREAT PATIENTS WITH MUSCLE-INVASIVE BLADDER CANCER
IRAS ID
261447
Contact name
Simon Crabb
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Eudract number
2019-001310-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
This study is looking at whether a type of immunotherapy drug called durvalumab can be safely administered after the initial treatment received by patients. Durvalumab has been tested in many different types of cancers and works by allowing the immune system to detect cancer and reactivate the immune response. This may help to slow down the growth of cancer or may cause cancer cells to die.
It is unclear if the addition of durvalumab is beneficial in patients with bladder cancer who have completed initial surgery, radiotherapy and chemotherapy (trimodality therapy - TMT). This project sets out to address this question.
Following TMT, 238 adult participants, aged 18 years or older, with muscle-invasive bladder cancer will be equally randomized to receive either durvalumab (1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months) or surveillance only.
During this time, patients will come to hospital for treatment every 4 weeks. During these visits, patients will have some blood tests to make sure they are well enough to receive treatment and will sometimes be asked to complete a questionnaire, asking about their health and quality of life. Patients will have CT scans, every 4-12 weeks to measure changes in the size of their tumour.
At the end of the trial, we will compare the two groups of patients to see if there are differences in terms of survival, how long we can stop the disease from getting worse (progressing), quality of life and costs of treatment.
Also, we will collect blood and tumour samples which will be sent to a laboratory in Canada. They will be analysed to tell us more about how the treatments work and whether some patients may benefit more from treatment than others. This may help target treatments to those most likely to respond in the future.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
19/EE/0348
Date of REC Opinion
29 Jan 2020
REC opinion
Further Information Favourable Opinion