EPILOGUE
Phase I/II combination umbrella trial in relapsed pediatric low-grade glioma (pLGG).Progressive, relapsed and refractory paediatric low-grade glioma (pLGG) is a serious and potentially fatal disease for which there is currently no standard of care (SOC) after systemic frontline SOC treatments. pLGGs are a group of tumors that affect children, teenagers, and young adults. They are the most common tumors of the brain and spinal cord in young people.
pLGG is considered a chronic disease and patients with pLGG can suffer from significant damage to vital functions and long-lasting side effects throughout their lives.
The EPILOGUE trial applies an intra-individual dose escalation concept to achieve the optimal tolerable dose for each patient for different (combination) treatment arms. The study design is an exploratory, open label, combination phase I/II umbrella trial of ulixertinib, tovorafenib, and vinblastine in pediatric patients with relapsed/refractory/progressive pLGG.
Population: Paediatric | Intervention type: Interventional