Subjects with newly diagnosed advanced-stage cHL will be enrolled in the trial. Credit: TippaPatt / Shutterstock.
Foresight Diagnostics and the University of Washington School of Medicine and Fred Hutch Cancer Center have announced the launch of the PRECISE-HL trial, which will use the Foresight Clarity laboratory-developed test (LDT) to examine personalised treatment for individuals with advanced-stage classical Hodgkin lymphoma (cHL).
Employing PhasED-Seq technology, the test is a circulating tumour DNA (ctDNA)-based minimal residual disease (MRD) LDT.
The trial aims to evaluate the possibility of decreasing chemotherapy exposure for subjects who show an early response to treatment.
Subjects with newly diagnosed advanced-stage cHL will be enrolled in the trial. They will receive two cycles of nivolumab combined with AVD therapy (doxorubicin, vinblastine, and dacarbazine).
Following the interim assessment using the test, subjects who have undetectable ctDNA will switch to nivolumab monotherapy for two cycles after only four cycles of nivolumab plus AVD.
In contrast, those with detectable ctDNA will progress with the full six cycles.
The trial will also explore end of therapy ctDNA-MRD analysis as an exploratory endpoint.
According to the company, the standard treatment for newly diagnosed advanced cHL patients currently involves multiple cycles of chemotherapy.
The University of Washington School of Medicine’s research showed that more than 70% of subjects reached undetectable MRD by the end of cycle two, when they were treated with a programmed cell death protein 1 (PD-1) inhibitor and chemotherapy combo.
Despite these outcomes, prolonged chemotherapy remains the standard care, often leading to long-term side effects, stated the company.
Foresight Diagnostics research head and chief medical officer Dr David Kurtz said: “The PRECISE-HL trial represents a significant milestone in our pursuit of using MRD to personalise therapy for patients. This study complements the SHORTEN-ctDNA trial in diffuse large B-cell lymphoma (DLBCL), that Foresight Diagnostics is also supporting, in seeking to reduce patient exposure to chemotherapy.
“The performance of the Foresight Clarity technology enables us to research more personalised treatment approaches that were previously not feasible.”
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