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

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.

Timeline

Start

2022-06-24

Primary completion

2026-06

Completion

2030-06

Publications

• Petrausch U, Spahn M, Schneider M, Hayoz S, Rentsch CA, Rothschild S, Omlin A, Cathomas R. Novel sequential treatment strategy for patients with muscle-invasive bladder cancer (MIBC): intravesical recombinant BCG, followed by neoadjuvant chemoimmunotherapy, radical cystectomy plus pelvic lymphadenectomy and adjuvant immunotherapy - protocol of a multicentre, single arm phase 2 trial (SAKK 06/19). BMJ Open. 2023 Jun 7;13(6):e067634. doi: 10.1136/bmjopen-2022-067634.

Drugs

Indications