Successful implementation of a novel trial model: The Signature program.

106 Background: Here we describe 8 ongoing single agent clinical protocols under Novartis’ “Signature” program involving buparlisib (BKM120, PI3Ki), dovitinib (TKI258, multikinase inhibitor), binimetinib (MEK162, MEKi), encorafenib (LGX818, RAFi), ribociclib (LEE011, CDK4/6i), BGJ398 (FGFRi), ceritinib (LDK378, ALKi) and sonidegib (LDE225; SMOi). These are tissue-agnostic, genetic alteration-specific (mutation, amplification, translocation, etc.) protocols using patients (pts) identified via standard-of-care profiling. This brings the ‘Protocol to the Patient’ for pts with actionable genetic alterations and who would like access to drugs targeting those alterations. Methods: Pts with advanced solid and hematologic cancers and no standard therapeutic options are eligible. Pts are preidentified with a local test performed in a CLIA laboratory for an actionable genetic alteration. Indications where existing data showed no benefit, or key studies were planned, were excluded from accrual. The primary objective...