CONNECT TarGeT
We are thrilled to announce the official launch of the CONNECT molecularly-guided phase II umbrella trial TarGeTĀ (Targeted pediatric high-grade Glioma Therapy), offering an innovative precision medicine treatment approach for children and young adults (age 12 months to </=39 years) newly-diagnosed with high-grade glioma (HGG), including DIPG.
All patients will undergo comprehensive molecular tumor characterization with rapid return of results to guide arm assignment to one of several biologically-targeted treatment arms (following and/or concurrent with upfront radiation) based on their individual tumor genomic profile, as illustrated in the schema below.
The first protocols to open will be TarGeT-SCR (overarching screening protocol, which all patients must initially enroll on, with 3 options for screening) and TarGeT-A (ribociclib and everolimus for HGG/DIPG with cell cycle and/or PI3K/mTOR pathway alterations), with several other treatment arms soon to follow.
Patients can enroll on the screening protocol up to 21 days post completion of radiation, though we encourage screening as early as possible. All patients must begin radiation by 31 days following definitive surgery, and patients must start treatment on TarGeT-A by 35 days post completion of radiation.
This trial will be open at CONNECT consortium sites, first opening in the US, and then expanding to international sites.