Clinical Trial

Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC

Active, Not Recruiting Phase 2
View on ClinicalTrials.gov →
Record status
This record was last updated January 21, 2026 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.
Summary
Current treatment of localized muscle-invasive bladder cancer is still associated with high relapse and death rate as well as the need for complete bladder resection or irradiation. The primary objective of this trial is to increase the rate of pathologic complete remission (pCR) at the time of radical cystectomy by the combination of local bladder instillation with Bacillus Calmette Guérin (BCG) in combination with systemic immunotherapy with atezolizumab and standard chemotherapy with cisplatin/gemcitabine. The trial tests the hypothesis whether BCG can enhance systemic and local immune response and thereby increase pCR rate and consequently also event-free survival. Improving pCR rate would be a next step to the ultimate goal of omitting radical surgery or extensive local radiotherapy to the bladder for these patients.
Protocol Amendment History 17 amendments
This ClinicalTrials.gov record has been amended 17 times since 2020-11-13; most recent amendment 2026-01-16.
Status change: Recruiting → Active, Not Recruiting 2025-05-07
Status change: Active, Not Recruiting → Recruiting 2023-08-22
Status change: Suspended → Active, Not Recruiting 2023-08-17
Status change: Active, Not Recruiting → Suspended 2022-11-03
Status change: Recruiting → Active, Not Recruiting 2022-10-28
Status change: Not Yet Recruiting → Recruiting 2022-04-05
Trial Details
NCT Number NCT04630730
Lead Sponsor Swiss Cancer Institute
Conditions Bladder Cancer
Enrollment 46 participants
Start Date 2022-06-24
Primary Completion 2026-06 (estimated)
Study Completion 2030-06 (estimated)
Updated on ClinicalTrials.gov 2026-01-21