Pediatric low-grade gliomas (PLGGs) are the most common brain tumours in children, and often necessitate systemic therapy as they are inoperable due to their location. Presently, chemotherapy constitutes the standard care, albeit with a low response rate and frequent disease progression after initial treatment.

Prior clinical trials indicate that MEK inhibitors (MEKi), when used alone for patients with relapsed, refractory, or progressive PLGG, result in a tumour size reduction of more than 70 percent and provide excellent tolerance and quality of life. To expand on these remarkable results, the ACCESS Clinical Trials theme is supporting a first-of-its-kind clinical trial that aims to revolutionize the treatment options for newly diagnosed patients with PLGG by employing a combination approach (chemotherapy plus MEKi) for treatment.

The Canadian-led MIRV (MIRdametinib and Vinblastine) phase 1/2 multi-centre clinical trial will assess the safety and efficacy of mirdametinib, an MEKi combined with vinblastine (chemotherapy) in newly diagnosed PLGG patients.

The trial’s primary objective is to determine the effect of the combination therapy on tumour reduction. The secondary objectives of the trial include evaluating the safety and tolerability of the combination therapy as well as assessing the impact of the combination therapy on survival, disease progression and neurological function.

The Clinical Trials research theme is dedicated to facilitating the participation of every eligible child in this trial and grant access to the latest and most promising treatment for PLGG patients. This will be done by involving a minimum of nine Canadian centres and integrating the use of satellite sites, where possible, to minimize travel time for patients and families, aiming to enhance outreach to communities and minorities historically underrepresented in clinical trials.