The ARCHER study will evaluate shortened radiation therapy while using ctDNA testing to monitor treatment response and disease recurrence.
Natera Inc has announced the activation of the NRG Oncology ARCHER trial (NRG-GU015), a randomized phase III study in muscle-invasive bladder cancer that incorporates the company’s Signatera molecular residual disease test as a pre-specified secondary endpoint.
The study will evaluate whether a shorter course of radiation can achieve outcomes comparable to current standard of care while using circulating tumor DNA testing to monitor treatment response. The trial is sponsored by NRG Oncology through the National Cancer Institute’s National Clinical Trials Network and is expected to enroll patients from more than 100 sites across the US and Canada.
Signatera, Natera’s personalized, tumor-informed molecular residual disease test, will be collected and reported to investigators during treatment and follow-up at defined timepoints. The test will enable investigators to evaluate real-time ctDNA clearance patterns in each treatment arm as a predictive marker of treatment response and recurrence.
Focus on Quality of Life and Treatment Optimization
Muscle-invasive bladder cancer accounts for approximately one-quarter of all bladder cancer cases in the US and typically requires aggressive treatment. The ARCHER trial aims to identify therapeutic approaches that can achieve promising clinical outcomes while maximizing patient quality of life.
“With Signatera as a key assessment in the ARCHER trial, we aim to evaluate ctDNA dynamics to detect early molecular signs of disease recurrence in real time and refine our clinical surveillance toolbox beyond imaging and cystoscopy,” says Catherine Spina, MD, PhD, co-chair of translational science for the study, in a release.
The study design reflects growing interest in bladder-sparing treatment options and the potential for molecular testing to guide treatment decisions. Signatera has been clinically validated in muscle-invasive bladder cancer to detect recurrence months before standard imaging and to independently predict recurrence risk following curative-intent therapy.
Expanding Clinical Evidence Base
Natera will also assess urine tumor DNA as an exploratory endpoint in the ARCHER trial, adding to the company’s growing body of evidence in muscle-invasive bladder cancer. The launch follows recent positive topline results from the randomized phase III IMVigor011 trial, which demonstrated Signatera’s ability to predict adjuvant immunotherapy benefit in patients post-cystectomy.
“By 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,” says Minetta Liu, MD, chief medical officer of oncology at Natera, in a release. “The use of serial Signatera testing in ARCHER represents an important step forward in determining how MRD insights can guide more precise patient management.”
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