NEW YORK – Naveris said Wednesday that it has begun a Phase II clinical study in partnership with Memorial Sloan Kettering Cancer Center that will use its NavDx minimal residual disease assay to monitor patients treated for HPV-driven head and neck tumors and to identify those whose cancer is recurring.
The multicenter randomized study is evaluating the efficacy of HB-200, an investigational treatment for patients with HPV16-positive head and neck squamous cell cancer who test positive for circulating tumor DNA after prior treatment. According to the company, it is the first MRD-driven interventional trial in this population.
NavDx detects HPV DNA in the blood as an indicator of lingering or recurrent disease. The trial will test patients prior to, during, and following their initial curative-intent treatment. To be eligible for the trial drug, individuals are required to have a positive test result three or more months after they received their initial definitive treatment.
"The findings from this study will provide critical insights into the utility of treating patients identified at the early stage of molecular relapse," said Alan Ho, a head and neck oncologist at Memorial Sloan Kettering, the primary principal investigator for the study.