NCT04878250

Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder

A Phase II Study Investigating Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (estimated)
• Sponsor: Queen Mary University of London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Transitional Cell Carcinoma
• Bladder Cancer

Interventions

Type	Name	Description
DRUG	Bintrafusp alfa	4 doses of bintrafusp alfa (1200mg flat dose) administered intravenously at 14 day intervals before undergoing radical cystectomy.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-07-01
• Completion: 2025-01-01
• First posted: 2021-05-07
• Last updated: 2021-05-07