The Phase 3 clinical trial (NCT04660344) investigating atezolizumab as adjuvant therapy for high-risk, ctDNA-positive muscle-invasive bladder cancer reached its primary completion on 2025-06-15. This randomized, placebo-controlled study evaluated the efficacy and safety of atezolizumab in participants following cystectomy.
Background
Atezolizumab (marketed as Tecentriq) is being investigated as an adjuvant treatment for participants with high-risk muscle-invasive bladder cancer (MIBC) who are circulating tumor deoxyribonucleic acid (ctDNA) positive following cystectomy. This population is considered to be at high risk for recurrence.
Trial design
The trial, identified as NCT04660344, is a global Phase 3, randomized, placebo-controlled, double-blind study. It enrolled 761 participants diagnosed with muscle-invasive bladder cancer (MIBC) who were ctDNA positive and at high risk for recurrence after cystectomy. The study was designed to compare the efficacy and safety of adjuvant treatment with atezolizumab against placebo.
What this means
The primary completion of this Phase 3 trial for atezolizumab in high-risk MIBC marks a significant milestone in its development. While specific results are not yet available, the completion of this phase indicates that the study has concluded its primary data collection period. The findings from this trial will be crucial for understanding the potential role of atezolizumab as an adjuvant therapy in this specific patient population, particularly those with ctDNA positivity post-cystectomy, who face a high risk of recurrence.
Source
The information regarding the primary completion of this trial was sourced from ClinicalTrials.gov, a public database of clinical studies. The record for study NCT04660344, titled "A Study of Atezolizumab Versus Placebo as Adjuvant Therapy in Participants With High-risk Muscle-invasive Bladder Cancer (MIBC) Who Are ctDNA Positive Following Cystectomy," indicates a primary completion date of 2025-06-15 on clinicaltrials.gov.