The standard-of-care for muscle-invasive bladder cancer is radical surgery with neoadjuvant cisplatin-based chemotherapy. Despite curative intent from these interventions, relapse rates post-surgery remain high, with approximately 50% of patients developing local or distant recurrence within 2 years of surgery and a 5-year survival of only 50-60%. Identifying patients who are high risk for relapse post-surgery is a priority. Monitoring patients for circulating tumor DNA (ctDNA) is a minimally invasive approach that appears attractive for selecting patients potentially suitable for adjuvant treatment with checkpoint inhibitors. IMvigor011 (NCT04660344) is a global, double-blind, randomized phase III study assessing the efficacy of atezolizumab (anti-PD-L1) versus placebo in patients with high-risk muscle-invasive bladder cancer who are ctDNA positive post-cystectomy. The primary end point is disease-free survival in participants who are ctDNA positive within 20 weeks of cystectomy.
Keywords: adjuvant therapy; atezolizumab; biomarkers; bladder cancer; ctDNA; immune checkpoint inhibitors; upper tract tumors; urothelial carcinoma.
Imvigor011 is a clinical trial looking at whether selecting patients who have signs of residual cancer molecules in their blood after having an operation for bladder cancer is better than the standard-of-care surveillance CT scans. This may be useful in picking up cancer that has come back after surgery, before it would be visible on CT scans. Patients who have had surgery for bladder cancer will have regular blood tests for 1 year after their surgery. If this cancer molecule is detected in their blood, it may indicate that the cancer has come back. These patients are then allocated by chance into one of two groups: receiving either an anticancer treatment or a placebo. Previous studies have suggested that giving anticancer treatment to patients who have this residual cancer molecule in their blood will improve how well they do after surgery. Clinical Trial Registration: NCT04660344 (ClinicalTrials.gov).