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Preoperative Bintrafusp Alfa in Operable Urothelial Carcinoma of the Bladder

NCT04878250 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2021-05-07

No results posted yet for this study

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

Interventions

DRUG

Bintrafusp alfa

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

Sponsors & Collaborators

  • Queen Mary University of London

    lead OTHER

Principal Investigators

  • Thomas Powles · Queen Mary University of London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-30
Primary Completion
2023-07-31
Completion
2025-01-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04878250 on ClinicalTrials.gov