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ACTIVE NOT RECRUITING
NCT04630730
PHASE2

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

Sponsor: Swiss Cancer Institute

View on ClinicalTrials.gov

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.

Official title: Intravesical Recombinant BCG (Bacillus Calmette Guérin) Followed by Perioperative Chemo-immunotherapy for Patients With Muscle-invasive Bladder Cancer (MIBC). A Multicenter, Single-arm Phase II Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

46

Start Date

2022-06-24

Completion Date

2030-06

Last Updated

2026-01-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

Recombinant intravesical BCG (Bacillus Calmette-Guérin VPM1002BC)

1 dose of VPM1002BC, live, 1-19.2 x 108 colony forming units (CFU) on day 1, 8 (+/- 1 day) and 15 (+/- 1 day)

DRUG

Atezolizumab

Neoadjuvant immunotherapy with atezolizumab, 4 cycles 1200 mg fixed dose iv infusion on d1 q3w starting 4-16 weeks after date of surgery

DRUG

Cisplatin

Neoadjuvant chemotherapy with cisplatin: 4 cycles 70mg/m2 iv infusion on d1 q3w (starting on d22)

DRUG

Gemcitabine

Neoadjuvant chemotherapy with gemcitabine: 4 cycles 1000 mg/m2 iv infusion on d1 and d8 q3w (starting on d22)

Locations (10)

Klinik Hirslanden - Onkozentrum Hirslanden

Zurich, Canton of Zurich, Switzerland

Kantonsspital Baden

Baden, Switzerland

Universitaetsspital Basel

Basel, Switzerland

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli

Bellinzona, Switzerland

Lindenhofspital

Bern, Switzerland

Kantonsspital Graubuenden

Chur, Switzerland

Hôpitaux Universitaires Genève HUG

Geneva, Switzerland

Luzerner Kantonsspital

Lucerne, Switzerland

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

UniversitaetsSpital Zuerich

Zurich, Switzerland