The US National Clinical Trials Network (NCTN) has teamed with DNA testing firm Natera to use biomarkers in a study focused on muscle-invasive urothelial cancer (MIUC).
The Phase II/III study – known as Alliance A032103 or MODERN – will use Natera’s personalized and tumor-informed molecular residual disease (MRD) test – called Signatera - to personalize treatment for the 1,000 or so people who take part in the study.
MRD-positive participants will have treatment randomized to either nivolumab, a PD-1 antibody, or escalation with nivolumab, a PD-1 antibody plus relatlimab, a LAG-3 antibody; LAG-3 and PD-1 are distinct inhibitory immune checkpoints.
MRD negative patients will be randomized to either nivolumab, a standard of care therapy, or de-escalation to surveillance, with the surveilled patients receiving treatment only upon future conversion to MRD-positive status based on serial testing.
Matthew Galsky, associate director for translational research at the Tisch Cancer Institute, described the collaboration as a step towards precision medicine in bladder cancer treatment.
“By using Signatera to measure residual cancer after surgery, the Alliance A032103 trial may ultimately help to tailor the use of immunotherapy after surgery and optimize the care of individual patients.”
Minetta Liu, managing director and chief medical officer of oncology at Natera, said that the collaboration would build on an earlier study – CIRCULATE - that also used Signatera to guide treatment.
“MODERN, like the CIRCULATE clinical trials in colorectal cancer, is a pivotal study that examines how Signatera-guided escalation and de-escalation pathways can potentially improve patient outcomes. We are grateful to collaborate with the Alliance on this important study.”
The NCTN is a group of organizations and clinicians that coordinates cancer clinical trials at more than 2,200 sites across the US, Canada, and internationally. NCTN provides the infrastructure for NCI-funded treatment and primary advanced imaging trials to improve the lives of people with cancer.
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