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Natera, Alliance for Clinical Trials in Oncology Partner for Urothelial Cancer Study

NEW YORK – Natera announced Monday that it launched a personalized cancer treatment clinical study in partnership with the Alliance for Clinical Trials in Oncology, part of the National Cancer Institute (NCI)-funded National Clinical Trials Network.

The Phase II/III Alliance A032103 (MODERN) trial will use Natera's blood-based Signatera minimal residual disease (MRD) assay to help guide treatment in patients diagnosed with muscle-invasive urothelial cancer (MIUC) after bladder removal.

The trial will enroll approximately 1,190 patients across more than 300 sites in North America, with participants divided into either MRD-positive or MRD-negative cohorts. MRD-positive patients will be randomized to receive either nivolumab (Bristol Myers Squibb's Opdivo), a standard-of-care PD-1 antibody, or escalation with nivolumab plus relatlimab, a LAG-3 antibody. LAG-3 and PD-1 are both inhibitory immune checkpoints. MRD-negative patients will be randomized to receive either nivolumab or de-escalation to surveillance. Surveilled patients will only receive treatment in the event that they convert to MRD-positive status following serial testing.

The MODERN trial follows results from the pivotal CheckMate 274 trial, which established the safety and efficacy of adjuvant nivolumab in MIUC and is currently the only therapy in this disease setting approved by the US Food and Drug Administration.

"By using Signatera to measure residual cancer after surgery, the Alliance A032103 (MODERN) trial may ultimately help to tailor the use of immunotherapy after surgery and optimize the care of individual patients," Matthew Galsky, codirector of the Center of Excellence for Bladder Cancer and the study's principal investigator, said in a statement.

Natera has been testing the use of its Signatera circulating tumor DNA test in guiding treatment decisions in the ongoing CIRCULATE studies. The company recently partnered with two French hospitals to support an ongoing randomized Phase III trial studying MRD-guided adjuvant treatment in stage II colorectal cancer.