NCT04630730View on ClinicalTrials.gov

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

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

June 24, 2022

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2030

Conditions
Bladder Cancer
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)

Trial Locations (10)

1211

Hôpitaux Universitaires Genève HUG, Geneva

3012

Lindenhofspital, Bern

4031

Universitaetsspital Basel, Basel

5404

Kantonsspital Baden, Baden

6000

Luzerner Kantonsspital, Lucerne

6500

Istituto Oncologico della Svizzera Italiana - Ospedale Regionale Bellinzona e Valli, Bellinzona

7000

Kantonsspital Graubuenden, Chur

8032

Klinik Hirslanden - Onkozentrum Hirslanden, Zurich

8091

UniversitaetsSpital Zuerich, Zurich

9007

Kantonsspital St. Gallen, Sankt Gallen

All Listed Sponsors
lead

Swiss Cancer Institute

OTHER