1st line treatment with MEDI4736 in urothelial bladder cancer (DANUBE)

• Research type

  Research Study

• Full title

  A phase III, randomised, open-label, controlled, multi-centre, global study of first-line MEDI4736 monotherapy and MEDI4736 in combination with tremelimumab versus standard of care chemotherapy in patients with unresectable stage IV urothelial bladder cancer

• IRAS ID

  186328

• Contact name

  Tom Powles

• Contact email

  thomas.powles@bartshealth.nhs.uk

• Sponsor organisation

  AstraZeneca

• Eudract number

  2015-001633-24

• Clinicaltrials.gov Identifier

  NCT02516241

• Duration of Study in the UK

  3 years, 8 months, 25 days

• Research summary

  This study is being done to compare 2 potential new treatments to the current Standard of Care treatment in patients who have bladder cancer. The study will aim to determine if the new treatments are as good as, or better, than the currently available treatments in terms of control of the tumour.

  In order to be able to take part in this study participants must be aged 18 years or above and be able to provide a tumour biopsy sample that was taken in the last 3 years, or, if this is not available, have a sample taken at the start of the study.

  Participants who are shown to be eligible for treatment will be randomly assigned to one of 3 treatment groups:
  • MEDI4736 in combination with tremelimumab – 12 months treatment
  • MEDI4736 alone – 12 months treatment
  • Standard of Care therapy – 6 cycles of treatment over approximately 6 months

  Participants allocated to treatment with either MEDI4736 and tremelimumab and complete the first 4 months of treatment, or MEDI4736 alone and complete the full 12-months of treatment, may have the option to restart treatment if the tumour starts to grow again.

  The treatment will be given by intravenous infusion, directly into a vein, over the course of 1-2 hours.

  Participants who are eligible for the study will visit the hospital site around once a month and will probably need to be there between half and one day. During that time they will undergo various tests such as blood and urine tests, Computerised Tomography(CT) or Magnetic Resonance Imaging (MRI) scans, electrocardiograms (ECGs) and physical examinations. Participants will also be given an electronic device (like a mobile phone) to take home with to complete some questionnaires on a weekly basis.

  Approximately 700 patients will be enrolled worldwide in order to treat 525 patients with approximately 18 patients taking part in the UK.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  15/LO/1612

• Date of REC Opinion

  13 Nov 2015

• REC opinion

  Further Information Favourable Opinion