Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- 614
Summary
- Conditions
- Bladder Cancer
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
ALBAN study will randomize 516 patients in 30 centers in France, according to a ratio 1:1 in the following arms of treatment: Arm A (control arm): BCG only Arm B (experimental arm): BCG+ atezolizumab The are two factors of stratifications (center and CIS).
ALBAN study will randomize 516 patients in 30 centers in France, according to a ratio 1:1 in the following arms of treatment: Arm A (control arm): BCG only Arm B (experimental arm): BCG+ atezolizumab The are two factors of stratifications (center and CIS).
Tracking Information
- NCT #
- NCT03799835
- Collaborators
- Hoffmann-La Roche
- Investigators
- Principal Investigator: Morgan Roupret, MD-PHD Hôpital Pitié-Salpétrière Principal Investigator: Yohann Loriot, MD Gustave Roussy, Cancer Campus, Grand Paris
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