Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder
Status:
Not yet recruiting
Trial end date:
2025-01-01
Target enrollment:
Participant gender:
Summary
PEBBLE is an open-label, international, multicentre, window of opportunity phase II trial
that aims to evaluate the effects of short-term preoperative therapy with bintrafusp alfa in
patients with histologically confirmed urothelial carcinoma requiring radical surgery with
bilateral pelvic lymph node dissection. Eligible patients will receive 4 doses of bintrafusp
alfa (1200mg flat dose) at 14 day intervals before undergoing radical surgery. Patients will
attend study visits at 6, 12 and 24 weeks following their surgery. After the 24-week
post-surgical 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.