US-based clinical genetic testing company Natera said that its Signatera test will be utilised in the newly activated ARCHER trial, a Phase III study sponsored by NRG Oncology.
The trial focuses on muscle-invasive bladder cancer (MIBC) and aims to assess whether a shorter radiation course can match current treatment outcomes.
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Signatera is included as a secondary endpoint for monitoring molecular residual disease (MRD) through circulating-tumour DNA (ctDNA).
The ARCHER trial is part of the US National Cancer Institute鈥檚 National Clinical Trials Network. It is anticipated to involve more than 100 sites across the US and Canada.
Investigators will use Signatera to track ctDNA clearance patterns during treatment and follow-up, providing a predictive marker for treatment response and recurrence. The trial will also explore urine tumour DNA for further data.
According to Natera, Signatera has been clinically validated to identify recurrence in MIBC months ahead of standard imaging and to predict recurrence risk after curative-intent therapy independently.
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By GlobalDataThe company claims that using ctDNA in MRD assessment allows for early detection of relapse through a sensitive and personalised approach.
Natera oncology chief medical officer Minetta Liu said: 鈥淏y exploring whether we can safely reduce the intensity and duration of therapy without compromising outcomes, ARCHER has the potential to ease patient burden and improve quality of life.
鈥淭he use of serial Signatera testing in ARCHER represents an important step forward in determining how MRD insights can guide more precise patient management.鈥�
Earlier this month, Natera announced that the Phase III IMvigor011 study demonstrated Signatera鈥檚 effectiveness in predicting which patients would benefit from adjuvant immunotherapy post-cystectomy.
This late-stage trial is sponsored by Roche鈥檚 Genentech.
In IMvigor011, around 760 patients underwent serial Signatera testing for up to 12 months after surgery. Patients testing positive were randomised to receive atezolizumab or placebo, with results showing improved disease-free and overall survival for those receiving treatment.
