https://orcid.org/0000-0001-7654-4889
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Abstract
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.
Plain language summary
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)
Financial & competing interests disclosure
B Szabados has received travel expenses and research funding from Roche, Genentech, Merck Sharp & Dohme, Pfizer and Bristol Myers Squibb and has received honoraria from Merck, Roche, Pfizer, Ellipses and Ipsen. T Powles has received travel expenses and research funding from Roche, Pfizer, MSD, AstraZeneca, Ipsen, BMS, Merck, Exelixis, Novartis, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson and Eisai and has received honoraria from Roche, Pfizer, MSD, AstraZeneca, Ipsen, BMS, Merck, Exelixis, Incyte, Novartis, Seattle Genetics, Merck Serono, Astellas, Johnson & Johnson and Eisai. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
No writing assistance was utilized in the production of this manuscript.
Ethical conduct of research
The study was designed collaboratively by the sponsor and lead study investigators. The protocol was approved by the sites’ institutional review boards and is being conducted in accordance with the Declaration of Helsinki and the International Council for Harmonisation Harmonized Tripartite Guidelines for GCP. All patients are required to provide written informed consent. An independent Data Monitoring Committee will review safety data approximately every 6 months. All authors will have access to the results, which will be analysed in collaboration with the sponsor.