NCT03799835

Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients

An Open Label, Randomized, Phase III Trial, Evaluating Efficacy of Atezolizumab in Addition to One Year BCG (Bacillus CaLmette-Guerin) Bladder Instillation in BCG-naive Patients With High-risk Non-muscle Invasive Bladder cANcer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 517 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multicentric study in patients with high-risk non-muscle invasive bladder cancer who had never received BCG for this disease. The primary objective is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.

Detailed description

ALBAN study recruited 517 patients in 45 centers in Europe (France, Belgium and Spain), 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).

Conditions

• Bladder Cancer

Interventions

Type	Name	Description
DRUG	BCG	Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®
DRUG	Atezolizumab	IV perfusion

Timeline

• Start date: 2019-01-17
• Primary completion: 2025-06-01
• Completion: 2028-10-01
• First posted: 2019-01-10
• Last updated: 2024-12-11

Locations

38 sites across 3 countries: Belgium, France, Spain