Atezolizumab Trial for High-Risk Bladder Cancer Reaches Primary Completion

By Hipa.ai Research · June 30, 2025

Synced daily from openFDA and ClinicalTrials.gov. Last sync: June 12, 2026.

The Phase 3 trial (NCT03799835) investigating atezolizumab in patients with high-risk non-muscle invasive bladder cancer reached its primary completion on June 30, 2025. This study, which enrolled 517 participants, aims to evaluate the efficacy of atezolizumab as measured by Event-Free survival when combined with one-year BCG bladder instillation in BCG-naive patients.

Background

Atezolizumab is an intervention being investigated for its role in treating bladder cancer. This specific trial focuses on patients with high-risk non-muscle invasive bladder cancer who have not previously received BCG for their disease, exploring a combination therapy approach.

Trial design

The study, officially titled "Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients" (NCT03799835), is an open-label, randomized, multicentric Phase 3 trial. It enrolled 517 participants. The trial investigates the combination of atezolizumab with one-year BCG bladder instillation in patients diagnosed with high-risk non-muscle invasive bladder cancer. These participants were specifically selected as they had never received BCG for this disease. The primary objective of the study is to evaluate the efficacy of atezolizumab as measured by Event-Free survival.

What this means

The primary completion of this Phase 3 trial is a significant milestone, indicating that the collection of data for the study's primary endpoint is now complete. This allows researchers to proceed with the comprehensive analysis of the collected data. The findings from this study will be crucial in understanding the potential role of atezolizumab in combination with BCG for patients with high-risk non-muscle invasive bladder cancer, particularly those who are BCG-naive.

Source

The information regarding the primary completion of this trial was obtained from ClinicalTrials.gov, a public database of clinical studies. The update for study NCT03799835, titled "Atezolizumab Plus One-year BCG Bladder Instillation in BCG-naive High-risk Non-muscle Invasive Bladder Cancer Patients," was posted on June 30, 2025, on clinicaltrials.gov.