PEBBLE

• Research type

  Research Study

• Full title

  A phase II study investigating preoperative bintrafusp alfa in operable urothelial carcinoma of the bladder.

• IRAS ID

  1003458

• Contact name

  Tom Powles

• Contact email

  orchidtrials@qmcr.qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Eudract number

  2020-004223-16

• ISRCTN Number

  ISRCTN17038127

• Clinicaltrials.gov Identifier

  NCT04878250

• Research summary

  Summary of Research
  PEBBLE is an open-label, international, multicentre, window of opportunity phase II trial that aims to evaluate the effects of shortterm
  preoperative therapy with bintrafusp alfa in patients with invasive bladder cancer (urothelial carcinoma) requiring surgical
  removal of the bladder (cystectomy). Eligible patients will receive 4 doses of bintrafusp alfa (1200mg flat dose) at 14 day intervals
  before undergoing surgery. Patients will attend study visits at 6, 12 and 24 weeks following their surgery. After the 24-week postsurgical
  visit, patients will enter a follow up phase during which they will be contacted annually for 2 years after their surgery to
  collect survival and disease status data. The efficacy of bintrafusp alfa will be assessed on CT/MRI scan images and tumour
  tissue samples collected at baseline and after treatment with bintrafusp alfa

  Summary of Results
  PEBBLE opened to recruitment in July 2021. Following the recruitment of two patients, the IMP manufacturer and study funder met with the Chief Investigator in October 2021 to discuss key data from their clinical trials portfolio involving bintrafusp alfa.
  Following on from these discussions, a request to stop recruitment and terminate the study was submitted to ethics committees and competent authorities in November 2021. At the time of termination there were two patients on treatment (UK=1 and Spain=1). These patients went on to have their cystectomy as per standard of care and the 6 week safety visit. Following this both patients came off study, with the last patient last visit taking place on 18 January 2022.
  As only two patients were recruited in the study the Sponsor will not proceed with data analysis. No results are therefore available

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  21/NW/0005

• Date of REC Opinion

  18 Feb 2021

• REC opinion

  Favourable Opinion