Foresight Diagnostics announced the launch of the PRECISE-HL clinical trial with the University of Washington School of Medicine and the Fred Hutch Cancer Center in Seattle.
The study will use Foresight CLARITY laboratory developed test (LDT), a circulating tumor DNA (ctDNA)-based MRD LDT, to investigate personalizing treatment for patients with advanced-stage classical Hodgkin lymphoma (cHL). The goal of the PRECISE-HL trial is to assess reducing chemotherapy exposure for patients who demonstrate early response to treatment.
The PRECISE-HL trial will enroll patients with newly diagnosed advanced-stage cHL, who will receive two cycles of nivolumab + AVD therapy (doxorubicin, vinblastine, and dacarbazine). After an interim assessment using Foresight CLARITY LDT, patients with undetectable ctDNA will transition to nivolumab monotherapy for two cycles after completing only four cycles of nivolumab + AVD, while patients with detectable ctDNA will continue with the full six cycles of nivolumab + AVD. End of therapy ctDNA-MRD analysis will also be an exploratory endpoint for the trial.